Key Organics is a UK-based contract research organization with over 28 years of experience in synthetic organic chemistry. They provide integrated drug discovery and development services from hit identification through pre-clinical development. Their services include custom synthesis, focused library design and synthesis using in-house fragment libraries and computational tools, hit-to-lead and lead optimization chemistry, process research and development, and delivery of pre-clinical batches. They emphasize transparent communication with customers and flexibility to adapt to changing project needs and timelines.
Ko services brochure-online-hi-jan2021bSteve Brough
• Fragment Libraries
• Screening compounds
• Large collection of building blocks and intermediates
• PROTACs
• Custom and contract synthesis
• Scale up and route development
• Stable label synthesis
Don’t Feed the Trolls – Crazy Powders and Electrostatic Charge in Continuous ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3to7vDj
Shifting pharmaceutical manufacturing of solid dosage forms from batch to continuous, feeding of excipients and API has gained significant relevance. New critical material attributes determine accurate and consistent performance. For stable long-term operation, understanding of risks for material adhesion is key.
Powder feeding is crucial for a robust continuous manufacturing (CM) operation and product quality. Even with modern gravimetric feeders, this can be a crossroad for CM as different powders interact distinctively with a given equipment. Due to the complex nature of powders, their behavior needs to be considered in a multivariate manner.
We will identify sources of feeding problems, present a set of experiments with a wide range of excipient powders and extract critical material attributes for successful feeding. We will show how feeding may alter powders, and specifically their electrostatic charge. Finally, we will present the effect of relative humidity (RH) on charge and related powder adhesion.
In this webinar, you will learn:
• Why feeding is highly relevant for continuous manufacturing
• How powder properties affect feeding performance
• Which feeding-induced alterations to powder properties may occur
• How relative humidity affects electrostatic charging and material adhesion
Successful Drug Development with Synthetic Lipids: Critical Aspects and Strat...MilliporeSigma
Lipid-based formulations and lipid nanoparticles are administration strategies of increasing importance in the pharmaceutical world. On the way to a successful drug product registration, there are numerous challenges to be overcome – from formulation development to meeting regulatory requirements and submission. In particular, care must be taken to choose appropriate lipids with respect to their type, source and quality, as these factors greatly affect the performance of the final formulation and also play a role in financial considerations.
In this webinar, you will:
● Explore critical aspects relating to synthetic lipids as raw materials for lipidic formulations
● Learn strategies to minimize risk when choosing lipidic raw materials for drug product development
● Gain insights into tailored manufacturing and lipids with optimized properties such as conjugation of targeting moieties
Fast-track solutions to address challenges with Host Cell Proteins in early d...Merck Life Sciences
Watch this webinar here: https://bit.ly/3fFRXDb
This webinar illustrates a customer case study about the challenges related to the removal of Host Cell Proteins from bioreactor harvest, the selected fast-track approach and outcome.
Our customer had one month to reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial. The high level of HCPs (1,000,000 in the harvest and 700 ppm at the end of purification) unfavorably impacted the planned clarification process and subsequent downstream steps.
The goal was to reduce the level of HCPs to maximum of 300 ppm at the end of process purification and ensure clarification of the entire 2000L harvest.
In this webinar, you will learn about:
- Challenges with Host Cell Proteins
- Fast-Track Approach using caprylic acid precipitation followed by filtration using Clarisolve® filters
- The impact of Design of Experiment
Watch the presentation of this webinar here: https://bit.ly/3ELoVzo
Understanding how your mAb behaves under various conditions is a crucial part of product characterization and quality assurance programs. Join this panel-style webinar to gain insights into key aspects of stability testing, from regulatory expectations to timeline and design considerations.
To ensure product safety and enhance understanding of product attributes, careful study of the effects of environmental conditions on your mAb is required throughout all phases of development.
Long and short-term stability studies are a critical part of a product development program and required by ICH guidelines. However, stability programs require extensive preparation and without this proper planning you may face additional hurdles.
Join our experts, Drs. Greg Pirozzi and Pamela Hamill, in a panel style discussion to learn how to proactively plan and execute a testing program to assess changes in stability that may impact product purity, potency and safety.
In this webinar, you will learn:
• Key considerations on when and how to effectively plan your stability testing program
• How to ensure the right selection of assays for your testing package
• How forced degradation/accelerated studies may fit into your overall plan, and evaluating repeat stability requirements after CMC changes
Presented by:
Greg Pirozzi, Ph.D.
Senior Project Manager, Custom Projects
Pamela Hamill, Ph.D.
Technical Consultant, Field Technology Management
Overview of Global Regulatory Affairs for Gene Therapy 2019Mridula Shukla
Presented by:
Mridula Shukla
Regulatory Affairs Global Lead
Author: RAPS study-guide for Global RAC
“International Regulatory Affairs (Chapter on Orphan Drugs)”
The document discusses the differences between discovery and development chemistry in drug development. Discovery chemistry focuses on synthesizing hundreds of compounds to explore biological activity, while development chemistry aims to optimize one or two compounds for regulatory approval. Both require synthetic chemistry expertise but development chemistry must consider scale-up, manufacturing, and regulatory requirements. The presentation provides examples of reaction maps to understand challenges and opportunities in synthetic processes during drug development.
The Butterfly Effect: How to see the impact of small changes to your ADCMilliporeSigma
This document summarizes key aspects of characterizing antibody drug conjugates (ADCs), including:
1) A case study examining how different polyethylene glycol (PEG) linker sizes affect ADC structure and target binding. Peptide mapping by mass spectrometry showed conjugation sites varied with linker size. Hydrogen/deuterium exchange mass spectrometry showed conjugation induced conformational changes.
2) Methods for assessing ADC mechanisms of action, including measuring internalization, cytotoxicity, and effector functions.
3) An overview of MilliporeSigma's comprehensive ADC product characterization and biosafety testing services across multiple sites.
Ko services brochure-online-hi-jan2021bSteve Brough
• Fragment Libraries
• Screening compounds
• Large collection of building blocks and intermediates
• PROTACs
• Custom and contract synthesis
• Scale up and route development
• Stable label synthesis
Don’t Feed the Trolls – Crazy Powders and Electrostatic Charge in Continuous ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3to7vDj
Shifting pharmaceutical manufacturing of solid dosage forms from batch to continuous, feeding of excipients and API has gained significant relevance. New critical material attributes determine accurate and consistent performance. For stable long-term operation, understanding of risks for material adhesion is key.
Powder feeding is crucial for a robust continuous manufacturing (CM) operation and product quality. Even with modern gravimetric feeders, this can be a crossroad for CM as different powders interact distinctively with a given equipment. Due to the complex nature of powders, their behavior needs to be considered in a multivariate manner.
We will identify sources of feeding problems, present a set of experiments with a wide range of excipient powders and extract critical material attributes for successful feeding. We will show how feeding may alter powders, and specifically their electrostatic charge. Finally, we will present the effect of relative humidity (RH) on charge and related powder adhesion.
In this webinar, you will learn:
• Why feeding is highly relevant for continuous manufacturing
• How powder properties affect feeding performance
• Which feeding-induced alterations to powder properties may occur
• How relative humidity affects electrostatic charging and material adhesion
Successful Drug Development with Synthetic Lipids: Critical Aspects and Strat...MilliporeSigma
Lipid-based formulations and lipid nanoparticles are administration strategies of increasing importance in the pharmaceutical world. On the way to a successful drug product registration, there are numerous challenges to be overcome – from formulation development to meeting regulatory requirements and submission. In particular, care must be taken to choose appropriate lipids with respect to their type, source and quality, as these factors greatly affect the performance of the final formulation and also play a role in financial considerations.
In this webinar, you will:
● Explore critical aspects relating to synthetic lipids as raw materials for lipidic formulations
● Learn strategies to minimize risk when choosing lipidic raw materials for drug product development
● Gain insights into tailored manufacturing and lipids with optimized properties such as conjugation of targeting moieties
Fast-track solutions to address challenges with Host Cell Proteins in early d...Merck Life Sciences
Watch this webinar here: https://bit.ly/3fFRXDb
This webinar illustrates a customer case study about the challenges related to the removal of Host Cell Proteins from bioreactor harvest, the selected fast-track approach and outcome.
Our customer had one month to reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial. The high level of HCPs (1,000,000 in the harvest and 700 ppm at the end of purification) unfavorably impacted the planned clarification process and subsequent downstream steps.
The goal was to reduce the level of HCPs to maximum of 300 ppm at the end of process purification and ensure clarification of the entire 2000L harvest.
In this webinar, you will learn about:
- Challenges with Host Cell Proteins
- Fast-Track Approach using caprylic acid precipitation followed by filtration using Clarisolve® filters
- The impact of Design of Experiment
Watch the presentation of this webinar here: https://bit.ly/3ELoVzo
Understanding how your mAb behaves under various conditions is a crucial part of product characterization and quality assurance programs. Join this panel-style webinar to gain insights into key aspects of stability testing, from regulatory expectations to timeline and design considerations.
To ensure product safety and enhance understanding of product attributes, careful study of the effects of environmental conditions on your mAb is required throughout all phases of development.
Long and short-term stability studies are a critical part of a product development program and required by ICH guidelines. However, stability programs require extensive preparation and without this proper planning you may face additional hurdles.
Join our experts, Drs. Greg Pirozzi and Pamela Hamill, in a panel style discussion to learn how to proactively plan and execute a testing program to assess changes in stability that may impact product purity, potency and safety.
In this webinar, you will learn:
• Key considerations on when and how to effectively plan your stability testing program
• How to ensure the right selection of assays for your testing package
• How forced degradation/accelerated studies may fit into your overall plan, and evaluating repeat stability requirements after CMC changes
Presented by:
Greg Pirozzi, Ph.D.
Senior Project Manager, Custom Projects
Pamela Hamill, Ph.D.
Technical Consultant, Field Technology Management
Overview of Global Regulatory Affairs for Gene Therapy 2019Mridula Shukla
Presented by:
Mridula Shukla
Regulatory Affairs Global Lead
Author: RAPS study-guide for Global RAC
“International Regulatory Affairs (Chapter on Orphan Drugs)”
The document discusses the differences between discovery and development chemistry in drug development. Discovery chemistry focuses on synthesizing hundreds of compounds to explore biological activity, while development chemistry aims to optimize one or two compounds for regulatory approval. Both require synthetic chemistry expertise but development chemistry must consider scale-up, manufacturing, and regulatory requirements. The presentation provides examples of reaction maps to understand challenges and opportunities in synthetic processes during drug development.
The Butterfly Effect: How to see the impact of small changes to your ADCMilliporeSigma
This document summarizes key aspects of characterizing antibody drug conjugates (ADCs), including:
1) A case study examining how different polyethylene glycol (PEG) linker sizes affect ADC structure and target binding. Peptide mapping by mass spectrometry showed conjugation sites varied with linker size. Hydrogen/deuterium exchange mass spectrometry showed conjugation induced conformational changes.
2) Methods for assessing ADC mechanisms of action, including measuring internalization, cytotoxicity, and effector functions.
3) An overview of MilliporeSigma's comprehensive ADC product characterization and biosafety testing services across multiple sites.
Kemwell provides extensive mammalian cell culture-based formulation development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology-transfers and process characterization.
The document summarizes a presentation given by Eric Kurzhals on the development of a cutting-edge CHO cell culture medium called the ActiCHO Media System. It discusses typical issues with existing cell culture media, such as being unbalanced and complex. The presentation then outlines how the ActiCHO system addresses these issues by having components designed to work together optimally and being fully chemically defined. It also describes how the system was developed through extensive experimentation and can be easily scaled from shake flasks to 1000L bioreactors with high productivity and batch-to-batch conformity.
Hot melt extrusion with PVA – solubility enhancement, supersaturation perform...Merck Life Sciences
Hot melt extrusion has successfully emerged as an innovative manufacturing technology in pharmaceutical industry for the creation of amorphous solid dispersions (ASDs).
In this webinar you will learn about the potential of hot melt extrusion to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA) as a matrix polymer. We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as actual formulation trends. You will get insights in potential down-stream options to create your final dosage form and you will gain ideas on how to speed up your formulation development.
A detailed background of PVA will be provided including its physical properties as well as its regulatory status. PVA is more than a polymer. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release. This highlights the versatility of PVA as an advanced polymer for HME applications and we will guide you through our latest research activities so that you can leverage our knowledge to improve your formulations.
This webinar includes:
- The current status and further potential of HME in pharmaceutical industry
- Advantages of PVA in the field of ASDs: Solubility improvement, impact on supersaturation potential, stability data generated on sample formulations & downstream options
- Deep dive into latest research activities: Permeation studies with Caco-2 cell membranes, pH shift studies to investigate supersaturation potential, ongoing research activities to get to know a more detailed understanding of matrix systems and their intermolecular interactions
In this webinar, you will learn:
- which potential hot melt extrusion has, to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA)
- why PVA is more than just a polymer
- how to create your final dosage form and speed up your formulation development
Oral presentation at ESACT 2015 (Barcelona) - Identification of process param...Albert Paul
Monoclonal antibodies (mAbs) are successful biotherapeutics in the treatment of various diseases. During manufacturing of mAbs higher molecular weight (HMW) aggregates can be formed during upstream (USP) and downstream (DSP) processing, which negatively influence product yields, reduce the therapeutic efficacy of the mAbs and trigger immunogenic responses upon administration. Reducing the level of aggregates during USP could improve the production of biopharmaceuticals and reduce the burden on expensive DSP removal of the HMW species. However, the lack of analytical tools to detect mAb aggregates in USP restricts understanding the origin of the aggregates and identifying cell culture conditions influencing product quality to reduce the level of mAb aggregates. We present a high-throughput compatible method which allows quantification of mAb aggregate formation directly in cell culture samples of Chinese hamster ovary (CHO) cells replacing falsifying, laborious and time-consuming chromatographic methods. Using this new methodology, we have screened for different culture conditions effecting mAb aggregate formation in a non-producing and a mAb producing CHO cell line. Finally, we have identified important process parameters to influencing protein aggregation in mammalian cell culture. Hence, our work demonstrates that the formation of mAb aggregates can be assessed directly in mammalian cell culture and product quality can be controlled by the selection of certain cell culture process parameters.
Extractables profiles for chromatography resins - adapted approach of upcomin...MilliporeSigma
Watch the webinar here: https://bit.ly/36JaZpx
In biopharmaceutical industry there is a trend towards comprehensive risk assessments of drug manufacturing processes. Extractables studies for chromatography resins based on the adapted requirements of the upcoming USP <665> support risk evaluation for your specific chromatography steps.
In this webinar, you will learn about:
- Study design for extractables profiles of chromatography resins
- The new category Emprove® Chromatography
- Communication of extractables data as part of Emprove® Dossiers
Description:
Detailed information on any component or material in contact with the drug substance/ product is required to conduct a compreshensive risk assessment of a biopharmaceutical manufacturing process. No explicit guidelines providing required testing procedures for chromatography steps are in place yet. In the upcoming USP <665> chapter chromatography steps are in focus as well as any other plastic or polymeric component and can as such assessed as to the described criteria. To support our chromatography resin users an adapted extractables study approach was developed. The webinar will demonstrate our study design and the communication of the extractables profiles within our Emprove® Program.
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
Mohan Raj is a research scientist with 12 years of experience in synthetic organic chemistry and process development. He currently works at Piramal Healthcare developing APIs and pursuing process improvements. Some of his accomplishments include developing new patented processes, receiving awards for yield improvements and cost reductions, and successfully completing projects from lab to plant scale. He is seeking a position that allows him to apply his expertise in organic synthesis, analytical characterization, quality assurance, and production.
Stabicon Life Sciences is a contract research organization located in Bangalore, India. It was established in 2010 and is approved by regulatory agencies in India, Canada, and the US. The company offers formulation development, analytical testing, stability studies, and other CRO services. It has a dedicated cGMP and cGLP compliant laboratory with experienced professionals and facilities for method development, validation, microbiology testing, and more. Stabicon aims to deliver high quality services to pharmaceutical clients at competitive costs while maintaining confidentiality and assisting throughout product development and registration.
From Screening to QC: Development Considerations for Octet MethodsKBI Biopharma
- The document discusses the development of potency assays using the Octet platform for biotherapeutics.
- Case studies are presented showing potency assays can be developed in 5-6 days using Octet compared to 5-7 days using other technologies like ELISA or SPR.
- Assays developed on Octet show good accuracy, precision, specificity, linearity and range meeting regulatory guidelines.
- Potency assays have been used to support process development and manufacturing through to quality control.
Open PHACTS (Sept 2013) EBI Industry ProgrammeSciBite Limited
This is a talk i'm giving for the EBI's industry programme on 18th Sept. The slides are mostly what you may have seen before with a few new ones thrown in to not make it too boring! With grateful acknowledgment of all the folks in Open PHACTS who make this stuff happen.
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Optimization of Glycosyation & Charge Distribution Through Culture Parameters...KBI Biopharma
This document summarizes three case studies conducted by Kinetic Biosciences Inc. regarding process optimization. Case Study 1 describes using a PAT approach involving daily charge variant testing to determine the optimal harvest day in three cGMP runs. Case Study 2 demonstrates how supplements can be used to customize product quality attributes like glycosylation. Case Study 3 shows that adding copper to the culture improved viability, titer and reproducibility that had been inconsistent due to variable pH changes after feeding. The document emphasizes the importance of analytics and surrogate markers in process development.
This document provides information about the ADC Summit conference to be held on May 23-24, 2016 in London. It includes:
- An agenda for the two-day conference featuring presentations and workshops on topics related to antibody-drug conjugates (ADCs), including developments, innovations, challenges and lessons learned.
- Information about two half-day post-conference workshops on May 25th regarding ADC payloads and developments in high potency API manufacturing.
- Details on registration, discounts, speakers, sponsors and exhibition opportunities for the conference.
Natural products company Hypha Discovery has signed a deal with Domainex to develop novel oncology drugs. Hypha has identified a pipeline of natural products with activity against tumor cell lines, including the HD148 chemical series inspired by compounds from a tropical mushroom. Domainex will use its drug development platform and medicinal chemistry expertise to optimize the HD148 series and deliver an advanced lead molecule and clinical candidate. Both companies look forward to the collaboration advancing Hypha's oncology programs.
Mohammed Akhlaq has over 20 years of experience in laboratory automation, assay development, and project support. He is an accomplished scientist with expertise in enzymatic, ligand-binding, and cell-based assays. Key achievements include implementing an acoustic dispensing platform and founding an automation user group. He has experience in liquid handling, detection methods, and informatics platforms.
Speed to GMP: Moving from Rapid Process Development to High Throughput Tech T...KBI Biopharma
This document discusses strategies for rapidly transferring biologics manufacturing processes from development to commercial production. It provides examples of how KBI Biopharma employs standardized platform processes and integrated development approaches to minimize changes between scales. For antibody processes, extensive use of platform cell lines, media, and unit operations allows seamless transfer. Non-antibody processes require more customization but subsequent products can still leverage a base platform. Tech transfer timelines are established early and deliverables like batch records are reviewed. This enables timely preparation for cGMP manufacturing and regulatory filings.
Our Mission: Launching & growing new Israeli biotech companies developing innovative protein-based biotherapeutics from early stage to late-clinical phase
Biodextris specializes in providing analytical development, process development, and quality control testing services for vaccines and biologics in clinical development. Comprised of experienced scientists located in Laval, Quebec, the group has worked together since 2002 developing numerous vaccine and biologic products. They offer a range of analytical, biophysical, physiochemical, immunological, and microbial characterization assays to support product development. Biodextris also provides process development, formulation, biomanufacturing, technology transfer, project management, and regulatory consulting services.
This document outlines a presentation on innovative strategies to accelerate drug development. It discusses Pfizer's locations in the UK and facilities for research, manufacturing, and commercial operations. Predictive science approaches using advanced data and technologies are described to enable accelerated development from molecule to medicine. Continuous manufacturing platforms and modular facilities are presented as ways to improve efficiency.
Kemwell provides extensive mammalian cell culture-based formulation development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology-transfers and process characterization.
The document summarizes a presentation given by Eric Kurzhals on the development of a cutting-edge CHO cell culture medium called the ActiCHO Media System. It discusses typical issues with existing cell culture media, such as being unbalanced and complex. The presentation then outlines how the ActiCHO system addresses these issues by having components designed to work together optimally and being fully chemically defined. It also describes how the system was developed through extensive experimentation and can be easily scaled from shake flasks to 1000L bioreactors with high productivity and batch-to-batch conformity.
Hot melt extrusion with PVA – solubility enhancement, supersaturation perform...Merck Life Sciences
Hot melt extrusion has successfully emerged as an innovative manufacturing technology in pharmaceutical industry for the creation of amorphous solid dispersions (ASDs).
In this webinar you will learn about the potential of hot melt extrusion to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA) as a matrix polymer. We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as actual formulation trends. You will get insights in potential down-stream options to create your final dosage form and you will gain ideas on how to speed up your formulation development.
A detailed background of PVA will be provided including its physical properties as well as its regulatory status. PVA is more than a polymer. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release. This highlights the versatility of PVA as an advanced polymer for HME applications and we will guide you through our latest research activities so that you can leverage our knowledge to improve your formulations.
This webinar includes:
- The current status and further potential of HME in pharmaceutical industry
- Advantages of PVA in the field of ASDs: Solubility improvement, impact on supersaturation potential, stability data generated on sample formulations & downstream options
- Deep dive into latest research activities: Permeation studies with Caco-2 cell membranes, pH shift studies to investigate supersaturation potential, ongoing research activities to get to know a more detailed understanding of matrix systems and their intermolecular interactions
In this webinar, you will learn:
- which potential hot melt extrusion has, to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA)
- why PVA is more than just a polymer
- how to create your final dosage form and speed up your formulation development
Oral presentation at ESACT 2015 (Barcelona) - Identification of process param...Albert Paul
Monoclonal antibodies (mAbs) are successful biotherapeutics in the treatment of various diseases. During manufacturing of mAbs higher molecular weight (HMW) aggregates can be formed during upstream (USP) and downstream (DSP) processing, which negatively influence product yields, reduce the therapeutic efficacy of the mAbs and trigger immunogenic responses upon administration. Reducing the level of aggregates during USP could improve the production of biopharmaceuticals and reduce the burden on expensive DSP removal of the HMW species. However, the lack of analytical tools to detect mAb aggregates in USP restricts understanding the origin of the aggregates and identifying cell culture conditions influencing product quality to reduce the level of mAb aggregates. We present a high-throughput compatible method which allows quantification of mAb aggregate formation directly in cell culture samples of Chinese hamster ovary (CHO) cells replacing falsifying, laborious and time-consuming chromatographic methods. Using this new methodology, we have screened for different culture conditions effecting mAb aggregate formation in a non-producing and a mAb producing CHO cell line. Finally, we have identified important process parameters to influencing protein aggregation in mammalian cell culture. Hence, our work demonstrates that the formation of mAb aggregates can be assessed directly in mammalian cell culture and product quality can be controlled by the selection of certain cell culture process parameters.
Extractables profiles for chromatography resins - adapted approach of upcomin...MilliporeSigma
Watch the webinar here: https://bit.ly/36JaZpx
In biopharmaceutical industry there is a trend towards comprehensive risk assessments of drug manufacturing processes. Extractables studies for chromatography resins based on the adapted requirements of the upcoming USP <665> support risk evaluation for your specific chromatography steps.
In this webinar, you will learn about:
- Study design for extractables profiles of chromatography resins
- The new category Emprove® Chromatography
- Communication of extractables data as part of Emprove® Dossiers
Description:
Detailed information on any component or material in contact with the drug substance/ product is required to conduct a compreshensive risk assessment of a biopharmaceutical manufacturing process. No explicit guidelines providing required testing procedures for chromatography steps are in place yet. In the upcoming USP <665> chapter chromatography steps are in focus as well as any other plastic or polymeric component and can as such assessed as to the described criteria. To support our chromatography resin users an adapted extractables study approach was developed. The webinar will demonstrate our study design and the communication of the extractables profiles within our Emprove® Program.
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
Mohan Raj is a research scientist with 12 years of experience in synthetic organic chemistry and process development. He currently works at Piramal Healthcare developing APIs and pursuing process improvements. Some of his accomplishments include developing new patented processes, receiving awards for yield improvements and cost reductions, and successfully completing projects from lab to plant scale. He is seeking a position that allows him to apply his expertise in organic synthesis, analytical characterization, quality assurance, and production.
Stabicon Life Sciences is a contract research organization located in Bangalore, India. It was established in 2010 and is approved by regulatory agencies in India, Canada, and the US. The company offers formulation development, analytical testing, stability studies, and other CRO services. It has a dedicated cGMP and cGLP compliant laboratory with experienced professionals and facilities for method development, validation, microbiology testing, and more. Stabicon aims to deliver high quality services to pharmaceutical clients at competitive costs while maintaining confidentiality and assisting throughout product development and registration.
From Screening to QC: Development Considerations for Octet MethodsKBI Biopharma
- The document discusses the development of potency assays using the Octet platform for biotherapeutics.
- Case studies are presented showing potency assays can be developed in 5-6 days using Octet compared to 5-7 days using other technologies like ELISA or SPR.
- Assays developed on Octet show good accuracy, precision, specificity, linearity and range meeting regulatory guidelines.
- Potency assays have been used to support process development and manufacturing through to quality control.
Open PHACTS (Sept 2013) EBI Industry ProgrammeSciBite Limited
This is a talk i'm giving for the EBI's industry programme on 18th Sept. The slides are mostly what you may have seen before with a few new ones thrown in to not make it too boring! With grateful acknowledgment of all the folks in Open PHACTS who make this stuff happen.
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Optimization of Glycosyation & Charge Distribution Through Culture Parameters...KBI Biopharma
This document summarizes three case studies conducted by Kinetic Biosciences Inc. regarding process optimization. Case Study 1 describes using a PAT approach involving daily charge variant testing to determine the optimal harvest day in three cGMP runs. Case Study 2 demonstrates how supplements can be used to customize product quality attributes like glycosylation. Case Study 3 shows that adding copper to the culture improved viability, titer and reproducibility that had been inconsistent due to variable pH changes after feeding. The document emphasizes the importance of analytics and surrogate markers in process development.
This document provides information about the ADC Summit conference to be held on May 23-24, 2016 in London. It includes:
- An agenda for the two-day conference featuring presentations and workshops on topics related to antibody-drug conjugates (ADCs), including developments, innovations, challenges and lessons learned.
- Information about two half-day post-conference workshops on May 25th regarding ADC payloads and developments in high potency API manufacturing.
- Details on registration, discounts, speakers, sponsors and exhibition opportunities for the conference.
Natural products company Hypha Discovery has signed a deal with Domainex to develop novel oncology drugs. Hypha has identified a pipeline of natural products with activity against tumor cell lines, including the HD148 chemical series inspired by compounds from a tropical mushroom. Domainex will use its drug development platform and medicinal chemistry expertise to optimize the HD148 series and deliver an advanced lead molecule and clinical candidate. Both companies look forward to the collaboration advancing Hypha's oncology programs.
Mohammed Akhlaq has over 20 years of experience in laboratory automation, assay development, and project support. He is an accomplished scientist with expertise in enzymatic, ligand-binding, and cell-based assays. Key achievements include implementing an acoustic dispensing platform and founding an automation user group. He has experience in liquid handling, detection methods, and informatics platforms.
Speed to GMP: Moving from Rapid Process Development to High Throughput Tech T...KBI Biopharma
This document discusses strategies for rapidly transferring biologics manufacturing processes from development to commercial production. It provides examples of how KBI Biopharma employs standardized platform processes and integrated development approaches to minimize changes between scales. For antibody processes, extensive use of platform cell lines, media, and unit operations allows seamless transfer. Non-antibody processes require more customization but subsequent products can still leverage a base platform. Tech transfer timelines are established early and deliverables like batch records are reviewed. This enables timely preparation for cGMP manufacturing and regulatory filings.
Our Mission: Launching & growing new Israeli biotech companies developing innovative protein-based biotherapeutics from early stage to late-clinical phase
Biodextris specializes in providing analytical development, process development, and quality control testing services for vaccines and biologics in clinical development. Comprised of experienced scientists located in Laval, Quebec, the group has worked together since 2002 developing numerous vaccine and biologic products. They offer a range of analytical, biophysical, physiochemical, immunological, and microbial characterization assays to support product development. Biodextris also provides process development, formulation, biomanufacturing, technology transfer, project management, and regulatory consulting services.
This document outlines a presentation on innovative strategies to accelerate drug development. It discusses Pfizer's locations in the UK and facilities for research, manufacturing, and commercial operations. Predictive science approaches using advanced data and technologies are described to enable accelerated development from molecule to medicine. Continuous manufacturing platforms and modular facilities are presented as ways to improve efficiency.
The document provides information about creating an effective biochemistry resume through BestResumeHelp.com. It discusses the services offered, including expert writers who specialize in biochemistry and can highlight skills, customized resumes tailored to each individual, keyword optimization for applicant tracking systems, and insights into industry trends. Tips are provided on what sets a strong biochemistry resume apart, such as an objective statement, education emphasis, technical skills, research experience, and relevant work or internship experience.
This document provides an overview and agenda for the 2nd annual conference on drug discovery taking place on March 21st-22nd, 2018 in London. The conference will feature presentations and discussions on:
1) New technologies to improve discovery cycles in chemistry and drug discovery processes, including the role of artificial intelligence and new modalities like PROTACs and antibodies.
2) Advances in small molecule therapeutics from Roche and challenges in validating targets with CRISPR from Epizyme.
3) The role of open access chemical probes from the SGC and how Bayer uses them in drug discovery.
4) How artificial intelligence can transform drug design and discovery efforts at companies like Exscient
This document announces a 10th anniversary conference for COMPOUND LIBRARIES celebrating developments in compound library design, screening, and collaborations over the past decade. The conference will include presentations and workshops on topics such as next generation library design for protein-protein interactions and epigenetic targets, exploring new chemical spaces, and leveraging large datasets and analytics to enhance hit identification and optimization. It provides an agenda with over 60 speakers from pharmaceutical and biotechnology companies discussing challenges and opportunities in medicinal chemistry and compound library design and screening.
10th International Conference Compound Libraries 2014Torben Haagh
VISIT THE CONFERENCE WEBSITE HERE:
http://bit.ly/CompoundLibrariesSlideshare
Maximizing information in early-phase R&D for an optimal library design and target selection
We are excited to conduct the 10th annual meeting of the formerly known Compound Libraries conference! Over the last decade we have provided the pharmaceutical R&D community with a wonderful platform for exchanging knowledge and ideas about how best to optimize the qualification of drug candidates.
We have hosted almost all major pharmaceutical companies and heard dozens of case-studies relating to important and acute issues. When returning back to the programs from previous years, it is interesting to look at the timeline of changing approaches, trends and market-related developments. Our topical spectrum ranged from compound management and acquisition to collaboration frameworks, open access, library design, screening and analysis.
This year we bring you 15 case studies about the most burning issues in early-stage discovery today and offer you a valuable trend-analysis and networking with peers and colleagues from pharmaceutical companies, biotechs, CROs and academic research institutes.
Don’t miss our 10th anniversary and join us in Berlin to take part at our legacy conference!
Benefit from participating in discussions about the following topics:
-10 years perspective on synthesizing and designing compound libraries
-What is the role of ligand efficiency metrics in drug discovery? Have your say in this controversial debate!
-Next generation library design - working towards better PPI and epigenetic libraries
-Exploration of bioactive and novel chemical space by application of privileged structure concept design
-Learn from Janssen’s experience with the assembly of the IMI European Lead Factory (ELF) library
-What is the real potential of macrocycles and are they the drugs of the future?
Xcelience is a contract research organization that has provided formulation development and clinical trial manufacturing solutions for pharmaceutical companies since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Core services include: API Characterization, Analytical Development and Stability Services, Formulation Development, and Clinical Trial Manufacturing, Packaging and Labeling. For more detailed information about Xcelience, visit www.xcelience.com
This document discusses analytical solutions for assessing the biosimilarity of a potential biosimilar to OPDIVO (nivolumab). It provides a pre-developed analytical master file containing preliminary critical quality attributes of OPDIVO, analytical methodologies to test these attributes, and preliminary reference data using OPDIVO. This master file can help support biosimilar development and provide a head start in assessing biosimilarity compared to de novo development. A comprehensive testing strategy is proposed to thoroughly characterize the biosimilar candidate and establish its biosimilarity to OPDIVO.
Medicilon is an integrated contract research organization (CRO), providing comprehensive one-stop R&D services for pharmaceutical enterprises and scientific research institutions around the world. https://www.medicilon.com/
Biosimilar CMC Analytical Master Files & Development SolutionsCovance
The successful development of a biosimilar presents unique challenges compared to that of an innovator biologic. In particular, one must prove the biosimilar candidate's structural and functional differences do not have a meaningful impact on the clinical safety and efficacy profile already established for the innovator. Comprehensive and rigorous analytical testing to assess biosimilarity is thus the foundation upon which the successful development of a biosimilar begins.
Hyderabad Laboratories Private Limited (HLPL) is a service providing organization based in Hyderabad, India that provides cost-effective chemistry solutions to pharmaceutical and chemical companies as well as academic researchers. HLPL uses experts to provide complex chemistry solutions like medicinal chemistry, custom synthesis, materials chemistry, and analytical services. HLPL's vision is to be a preferred global provider of quality research solutions to the pharmaceutical and chemical industries through dedicated efforts while protecting society and the environment.
The document is a resume for Kanagasabapathi S., highlighting his expertise and 10+ years of experience in bioanalytical method development and drug discovery. It summarizes his responsibilities developing over 1000 analytical methods for small molecules, conducting ADME assays, and managing projects. Currently he works as a Research Scientist at Syngene International Ltd, where he leads projects and trains junior scientists.
Clinical Research Organization Services | Contract Research Company - PepgraPEPGRA Healthcare
Pepgra is a global contract research organization and drug development services company. It provides various phases of clinical research trials services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development.
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
India: +91 9884350006
United Kingdom: +44- 74248 10299
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is specialized in managing product quality process, upgrading and introducing advanced technology into products. we are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business.
To learn more visit:
https://insidescientific.com/webinar/cutting-edge-conversations-discovering-new-innovations-in-oncology/
Starting off the conversation, Dr. David Bunka will present specific case studies for prostate cancer, multiple myeloma and chronic myelomonocytic leukaemia, highlighting the ability of Optimer technology to deliver novel targeted therapeutics for cancer treatment. Optimer binders are small, highly target specific oligonucleotide-based affinity binders. The Optimer platform offers the ability to develop specific binders targeted to a specific biomarker or to an oncological cell phenotype without the need for known biomarkers. Optimer therapeutics are enabling new strategies in cancer treatment, including the targeted delivery of diverse payloads to cancer cells for precision chemotherapy, or gene therapy approaches.
Dr. Cathie Miller will discuss how archived tissues contain valuable information for clinical research. For over thirty years, BioIVT has worked to expand the characterization of their archived tissues. BioIVT offers complete NGS project management that ensures success. In this presentation, Dr. Miller will review BioIVT’s comprehensive process, their strengths in sample collection through library prep, their in-house and validated partnership capabilities and how BioIVT elevates science.
Finally, Henry Sebesta will introduce KromaTiD’s proprietary technology, Directional Genomic Hybridization™, as an analytical solution for gene & cell therapy oncology treatments. Specifically, Mr. Sebesta will be addressing what Directional Genomic Hybridization is, how it works, and how it can be used to monitor highly important clinical safety metrics including therapeutic vector integration, and genome wide structural rearrangement events.
GVK BIO is one of the largest India-based Discovery, Development and Manufacturing solutions provider to the Biopharma industry. GVK BIO provides a continuum of Drug
Discovery solutions from pre-Hit to candidate
selection. Our expertise spans across
numerous therapeutic areas with a focus on
Oncology, Pain and Metabolic diseases. We
leverage our expertise in Chemistry, Biology,
CADD, ADMET/PK and Animal Disease models
to provide a customised and truly integrated
model for Drug Discovery leading to preclinical
candidates.
When your focus is small molecules, biomarkers, or protein biotherapeutics,
QPS’ LC-MS/MS laboratories provide a full range of
bioanalytical solutions to support drug development
from discovery through clinical development.
2. The Key Organics
Advantage
During the last 28 years, Key Organics has created value for its
customers through its intellectual and hands-on scientific input
which have accelerated their drug discovery projects into clinical
development and product launch.
Through our creative input, we continue to add inventive and patentable
intellectual property as well as developing new chemistries on a wide
range of intellectually and scientifically demanding projects that we
typically deliver to tight deadlines. Our staff have backgrounds from major
pharmaceutical, biotechnology and CRO/CMO’s that include AstraZeneca,
Pfizer, Evotec, Chiroscience, BTG and Novartis.
Our highly flexible business model comprises of FTE and custom chemistry which is carried
out under strict confidentiality. We operate a highly transparent and effective FTE project
management and communications programme that provides our customers with direct access
to project plans and data through our Accelrys Notebook, a Cloud-based e-notebook system.
Hit
Identification
DISCOVERY SERVICES EARLY DEVELOPMENT
Hit-to-lead
Lead
Optimization
Candidate
Selection
Pre-
Clinical
API
Supply
Key Organics Facts:
Who are we?
A UK-based CRO with over 28 years
expertise in synthetic organic chemistry.
Part of the Tennant Group of companies
(founded c. 1700) with >1,000
employees worldwide.
Our customers:
We work for a diverse range of
international life-science companies,
from pharmaceutical and biotechnology
firms to academic laboratories and new
start-up’s.
Our Services:
We offer a wide-range of integrated
bespoke chemistry solutions, from the
custom synthesis of a single compound
to multiple, long-term FTE programmes.
Flexibility:
We work in a close and flexible structure
with our customers as project milestones
often change and resources need to be
re-deployed.
Why work with us?
With established library design
capabilities, an extensive BIONET
product portfolio and a proven track
record in synthetic organic chemistry,
Key Organics is able to fully support
your drug discovery and development
chemistry needs. Our project managers
and scientists are highly experienced
at managing complexity and we
utilise Accelrys Notebook to facilitate
information exchange during our
FTE programmes.
We have worked on thousands
of demanding projects for many
of the world’s leading Life Science
companies from hit identification
to pre-clinical development,
successfully delivering value
through our innovative approach,
creativity and product supply.
Delivering Drug Discovery,
Lead Optimisation and Candidate
Development Support Services
Key Organics has experience in the following phases of
drug discovery and development:
• Hit Identification, fragments, library synthesis,
• Hit to Lead
• Lead Optimisation
• IP exemplification
• Isotope-labelled synthesis
• Route scouting
• Early Process Research & Development
• Delivery of pre clinical batches
• Process Related Impurity (PRI) Identification & Quantification
3. Hit identification, Computational Chemistry & Library Design
Key Organics provides a range of established strategies to deliver high-quality and validated hit compounds. With
substantial pharmaceutical industry experience and a highly experienced team of research scientists, we have
undertaken many successful hit-identification projects to produce synthetically-tractable hit series which have
advanced into the hit-to-lead phase.
We have drug discovery and development experience with small and large molecules (e.g. peptides) across a broad
range of therapeutic areas and biological drug-target classes.
Through our collaboration with Prosarix Limited, we offer a unique
computational library generation service, . These ‘ready to
run’ virtual libraries are combined with fast follow-on synthesis, and offer
a number of advantageous features:
• Novel and large drug-like chemistry space designed to a specific
target family (e.g. Kinases and SP1R)
• Library design based on in-house BIONET reagents and templates
which enables rapid synthesis
• Virtual screen of library aligned against Customers target
pharmacology profile
• Design and synthesis of compounds delivered
• Provides unique service capability for target class -
bespoke design and chemistry
KeyFinder Process
Novel chemotypes
for target class
Client target
selection
Library designs
Library screen
Ready to screen...
Virtual library
construction
Synthetic
candidate selection
Synthesis and
delivery
Testing
In-house reagents
Hit-to-Lead
We have undertaken numerous
projects involving the design
and synthesis of novel
molecules, either singletons
or using our parallel chemistry
techniques to prepare focused
arrays (typically up 10 to 50
compounds at 1 - 50mg scale)
with chemical purities of
≥95% (by LC-MS and NMR) for
in vitro screening and ADME
profiling.
Lead Optimization
We have extensive experience of collaborative R&D where we are able to move customer projects forward
through the milestones of Lead Optimisation. We add value through the analysis of data and providing
rationale suggestions on future targets using computational tools such as Data Warrior which is further
supported by our expertise in synthesis – driven target selection. Our approach is focused on enhancing
potency, improved physico-chemical properties, metabolic profile and building a strong IP position. Our
project management structure is highly flexible and we are able to respond rapidly to project changes.
This approach, coupled with a high level of productivity, enables a robust and efficient design/make/test
cycle to be established and maximises the use of resources.
In later Lead Optimisation, our team are highly experienced in the synthesis and investigation of more
challenging chemistry as the SAR is better understood and the need for more “bespoke” compounds
becomes clearer as well as establishing early route improvements for pre candidate compound
batches. We also have in depth experience of the synthesis of project support compounds such as
deuterium and 13
C labels for PK/PD studies and synthesis of competitor compounds to assist in profiling
and benchmarking.
Early PR&D Pre-clinical Candidate Delivery
Key Organics has supported many drug discovery programmes, from hit validation to preclinical studies. We have particular expertise in
the scale-up of synthetic routes to prepare multi-gram quantities of a lead compound for further studies. As many of our customers work
to tight deadlines, we seek to optimise the efficiency of a scale-up route, in terms of time and material costs, by reducing the number of
steps and finding alternatives to chromatographic purification. Our synthetic chemists work closely with our in-house analytical team to
ensure that final compounds meet or exceed the purity specification required by the customer.
The approach facilitates the generation of
novel lead candidates and associated new IP.
4. Isotope-labelledSynthesis
Through our Custom Synthesis programme,
we can provide deuterium and/or 13
C labeled
API’s, intermediates or metabolites.
One, non confidential, example was the recent
synthesis of the dual labeled form of Algoliptin,
the orally administered anti-diabetic drug in
the DPP-4 inhibitor class, originally developed
by Syrrx.
Through an established partnership, we can
also offer hot labeled API’s, also produced
under GMP conditions if required.
Synthetic Chemistry
Our team of highly experienced chemists have acquired extensive synthetic organic
chemistry capabilities and expertise that cover the following areas:
• Multi-step complex custom synthesis
• Asymmetric synthesis
• Heterocyclic chemistry
• Synthesis of literature standards
• Cold labelled compounds
• Pro-drug synthesis
• Manufacturing impurities and metabolites
• High pressure reactions (100mL – 4L autoclaves)
• Hydrogenations
• Carbonylations
• High temperature ammonia reactions
Unique, Proprietary Fragment Libraries
Key Organics has designed and synthesized several unique, proprietary
fragment libraries that includes; CNS, Premium Fragments
and a Fluorine set. Our new “2nd generation BIONET Premium
Fragment Library” (to be launched in Q1 2015) has been developed in close
collaboration with The Broad Institute (Cambridge MA, USA) and NMX Research
and Solutions (Montreal, Canada) according to the following design criteria:
• Rule of 3 compliant: MW ≤300, cLogP ≤ 3, number of HBA/HBD ≤ 3, PSA ≤ 60 and Number rotatable bonds ≤3
• Heavy atom count (HAC) ≤ 16
• Does not include substructures identified as promiscuous or reactive by empirically determined rules
(BMS, PAINS, Kazius and Bursi toxicophores, Lilly Med Chem Rules)
• Inclusion of diverse scaffolds that are present in bioactive compounds and that have 3-dimensionality
• Clustering and Diversity analysis
• Passes chemist visual inspection
• Solubility at 1mM in PBS buffer and signs of aggregation determined by 1
H NMR spectra
“Selection by scaffolds” is a powerful way of selecting molecules to yield synthesizable and recognizable structures.
The goal of selection will be to find fragment-like molecules with diverse scaffolds that are present in bioactive
compounds and that have 3-dimensionality. This unique library also maintains good diversity in functional groups.
13
CD3
-Alogliptin
N
N
NH2
N
O
O
D
13
C
D
D
N
5. How We Make a Difference
Transparent, Efficient & Honest Communication
For all FTE projects, we utilise the Accelrys Notebook, a Cloud-based e-notebook system that is both reliable and
secure. Customer project plans and experimental data can be readily accessed 24/7 through a free user-license. This
software and data transparency complements our communications approach that includes weekly or daily project-
update meetings as well as written reports as required by the client.
Access to our Proprietary BIONET Collection
Our proprietary BIONET product portfolio now contains over 80,000 R&D products that provide
a valuable resource for both FTE and custom synthesis projects. Many of our BIONET products
are available in Kg quantities and come with assured quality. Most are available in >97%
purity with full Certificate of Analysis that includes LC-MS and 400 MHz NMR data.
We add new BIONET products weekly through our own in-house R&D as well as external
alliances. We offer an unrivalled 100% guarantee for all of our BIONET products.
Key Endorsements
Our FTE-based collaborations involving medicinal and developmental
chemistry are regularly renewed and extended, demonstrating customer
confidence in our capabilities and ability to deliver outstanding results.
Endorsement by some of our recent customers:
“Over the past 6 years Key Organics
has successfully delivered both
FFS contracts and FTE contracts
for Heptares Therapeutics. I have
been particularly impressed with
the intellectual input provided
by Key Organics’ scientists,
their consistently high level of
productivity and their creativity
for providing innovative solutions
to difficult problems. We are
delighted with the success of our
collaborations with Key Organics
and are pleased to acknowledge the
important contribution they have
made to Heptares Therapeutics’
drug discovery efforts.”
Dr Giles A. Brown,
Associate Director Chemistry,
Heptares Therapeutics
“During a five year multiple FTE project, Key
Organics developed and assisted in patenting
a novel series of selective JAK3 inhibitors
and delivered over 200 compounds from
the initial hit to lead phase that resulted in
three candidates that had nm potency &
excellent JAK family selectivity. A granted
USA patent was obtained through their
input and contribution with PCT filings
pending in Europe, Japan & Canada. They
established and maintained an excellent
project management role with our biology
partner, Reaction Biology Corporation (RBC)
based in the United States and provided
an outstanding level of strategic as well as
hands-on synthetic chemistry throughout
the programme”.
Managing Director,
Synerga Limited.
Extensive, growing compound collection
Next-day courier delivery in EU
Dedicated customer support
>90% deliverable ex-stock
Novelty and Diversity
Same-day dispatch
High quality
Our BIONET Guarantees:
Intermediates
Fragment Libraries
Biochemicals
Screening Compounds
>80,000 Compounds
Products
“I have been extremely impressed by Key
Organics’ professionalism and candour during
separate multi-gram re-synthesis and route
development projects carried out recently.
In particular, Key communicated clearly
and rapidly with me when any obstacles to
project delivery were encountered. Their swift
and frank communication gave us time to
jointly devise solutions which ensured that
objectives were achieved while working to
tight deadlines. Key’s ability to formulate
innovative routes to important organic
compounds is also first rate. In this regard,
they dramatically improved the availability
of one of our crucial intermediates by
developing some neat chemistry that relied
upon unconventional thinking.”
Dr Matthew Fyfe,
Head of Chemistry,
TopiVert Pharma Ltd