Scynexis Fully Integrated Drug Discovery & Development 2011 Overviewbrycechaney
SCYNEXIS provides fully-integrated contract research solutions including medicinal chemistry, discovery biology, ADMET-PK, bioanalysis and analytical chemistry, process chemistry and cGMP manufacturing. We have delivered 11 Preclinical Candidates (PCCs) to our clients since 2005. We are FDA and DEA inspected.
Ask yourself - Do you want compounds... Or do you want DRUGS?
Innovative Drug Pipeline Solutions: Medicinal Chemistry, Process Chemistry, cGMP API Manufacturing. 105+ global clients. 120,000 sq.ft. facilities located in Research Triangle Park, NC USA. FDA inspected and DEA registered.
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
Scynexis Fully Integrated Drug Discovery & Development 2011 Overviewbrycechaney
SCYNEXIS provides fully-integrated contract research solutions including medicinal chemistry, discovery biology, ADMET-PK, bioanalysis and analytical chemistry, process chemistry and cGMP manufacturing. We have delivered 11 Preclinical Candidates (PCCs) to our clients since 2005. We are FDA and DEA inspected.
Ask yourself - Do you want compounds... Or do you want DRUGS?
Innovative Drug Pipeline Solutions: Medicinal Chemistry, Process Chemistry, cGMP API Manufacturing. 105+ global clients. 120,000 sq.ft. facilities located in Research Triangle Park, NC USA. FDA inspected and DEA registered.
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
TetraQ - Integrated Preclinical Drug Development Solutions Presentationguest55305
TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005.
Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.
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
Expanding the Compound Management toolkit: leveraging technology to streamlin...Pierre Baillargeon
The continual evolution of compound management labs in terms of sample capacity and capabilities provides opportunities to improve the associated QA and QC operations. As new technologies enable support of greater plate densities and library sizes, new approaches to QA and QC must follow suit.
• Review of potential for error in compound management labs and impact of new technology on QA/QC efficiency
• Leveraging sample color to quickly identify problems
• Novel methods for monitoring the health of large sample libraries over time
• Correlating visual properties of solubilized samples to experimental results and calculated properties
CoreRx, is a contract pharmaceutical development and manufacturing organization that helps get you into the clinic faster, providing a complete spectrum of cGMP solutions for pharmaceutical dosage form development. Our wide range of support services, extensive instrumentation and rigorous quality systems provide timely results communicated in a clear, efficient and consistent manner.
Established in 2012, EFRAC is a USFDA Inspected & BSE Listed Company having ISO
17025:2005 Accreditation in Chemical & Biological disciplines. Drugs & Cosmetics Division at
EFRAC is and advanced Pharmaceutical Testing Facility with Cutting-Edge Technology, 21 CFR Part
11 enabled & DQ, IQ, OQ, PQ, Qualified Instrumentation. EFRAC conducts a wide range of Tests in
Strict adherence to the Scientifically Approved Protocols and Standards by Drug Regulators like
CDSCO, WHO, MHRA & USFDA.
Watch the interactive recording here: https://bit.ly/30FTDG0
The quest for a viable upstream process relies on generation of a cell line expressing the protein of interest. Unfortunately, the search for the best-producing clone is often compared with looking for a needle in a haystack. Making this more challenging is the pressure to get it right the first time, quickly and while mitigating risk and costs.
Although a lot of efforts are made on the clonal selection, there is often few to none optimization done on the expression cassette, including promoter and enhancer selection, or signal peptide. The statistical approach on how many clones should be screened to get to a good producer is often overlooked as well.
We combined a new generation of promoters and enhancers to improve strategies on pool and mini pool screening with both CHO-K1 and our own CHOZN® GS which helped deliver high-producing clones in an accelerated timeline. In addition, we are able to begin process development in parallel with cell line development, further reducing timelines.
In this webinar, you will learn:
* How the strategy approach can help reducing the overall timeline of cell line generation
* How we have expanded our platform by designing a completely new vector/cell/process template
* How we have worked on promoters, enhancers, pool/mini-pool approach as well as on timelines from DNA to clone
Key to Successful Formulation Development for Lipid Based RNA Delivery and Va...MilliporeSigma
In this webinar, we will discuss:
• The application of RNA therapeutics and the different drug delivery routes used in the clinic.
• Design principles for developing lipids-based RNA formulations.
• Critical parameters to consider for cost effective development and consistent performance of RNA therapeutics and vaccines.
RNA therapeutics are changing the way we address diseases. Applications range from gene therapy, oncology, to vaccines for infectious diseases such as COVID-19.
The performance of RNA therapeutics critically depends on its formulation. Key decisions have to be made early on in the drug development process; choosing the appropriate drug delivery method and novel excipients. Raw material source and judicious choice of chemistry, ultimately determine the quality of novel lipid excipients which, in turn, has a big impact on the performance, reproducibility, costs, and regulatory approval timelines. This webinar will propose solutions to maximize the probability of success while formulating RNA therapeutics and vaccines.
Participate in the interactive webinar now: https://bit.ly/2xXMZlm
Explore our webinar library: www.emdmillipore.com/webinars
We focus on providing you lab testing services that accelerate R&D intensive projects. Follow us to share & learn about analytical testing research and more.
TetraQ - Integrated Preclinical Drug Development Solutions Presentationguest55305
TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005.
Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.
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
Expanding the Compound Management toolkit: leveraging technology to streamlin...Pierre Baillargeon
The continual evolution of compound management labs in terms of sample capacity and capabilities provides opportunities to improve the associated QA and QC operations. As new technologies enable support of greater plate densities and library sizes, new approaches to QA and QC must follow suit.
• Review of potential for error in compound management labs and impact of new technology on QA/QC efficiency
• Leveraging sample color to quickly identify problems
• Novel methods for monitoring the health of large sample libraries over time
• Correlating visual properties of solubilized samples to experimental results and calculated properties
CoreRx, is a contract pharmaceutical development and manufacturing organization that helps get you into the clinic faster, providing a complete spectrum of cGMP solutions for pharmaceutical dosage form development. Our wide range of support services, extensive instrumentation and rigorous quality systems provide timely results communicated in a clear, efficient and consistent manner.
Established in 2012, EFRAC is a USFDA Inspected & BSE Listed Company having ISO
17025:2005 Accreditation in Chemical & Biological disciplines. Drugs & Cosmetics Division at
EFRAC is and advanced Pharmaceutical Testing Facility with Cutting-Edge Technology, 21 CFR Part
11 enabled & DQ, IQ, OQ, PQ, Qualified Instrumentation. EFRAC conducts a wide range of Tests in
Strict adherence to the Scientifically Approved Protocols and Standards by Drug Regulators like
CDSCO, WHO, MHRA & USFDA.
Watch the interactive recording here: https://bit.ly/30FTDG0
The quest for a viable upstream process relies on generation of a cell line expressing the protein of interest. Unfortunately, the search for the best-producing clone is often compared with looking for a needle in a haystack. Making this more challenging is the pressure to get it right the first time, quickly and while mitigating risk and costs.
Although a lot of efforts are made on the clonal selection, there is often few to none optimization done on the expression cassette, including promoter and enhancer selection, or signal peptide. The statistical approach on how many clones should be screened to get to a good producer is often overlooked as well.
We combined a new generation of promoters and enhancers to improve strategies on pool and mini pool screening with both CHO-K1 and our own CHOZN® GS which helped deliver high-producing clones in an accelerated timeline. In addition, we are able to begin process development in parallel with cell line development, further reducing timelines.
In this webinar, you will learn:
* How the strategy approach can help reducing the overall timeline of cell line generation
* How we have expanded our platform by designing a completely new vector/cell/process template
* How we have worked on promoters, enhancers, pool/mini-pool approach as well as on timelines from DNA to clone
Key to Successful Formulation Development for Lipid Based RNA Delivery and Va...MilliporeSigma
In this webinar, we will discuss:
• The application of RNA therapeutics and the different drug delivery routes used in the clinic.
• Design principles for developing lipids-based RNA formulations.
• Critical parameters to consider for cost effective development and consistent performance of RNA therapeutics and vaccines.
RNA therapeutics are changing the way we address diseases. Applications range from gene therapy, oncology, to vaccines for infectious diseases such as COVID-19.
The performance of RNA therapeutics critically depends on its formulation. Key decisions have to be made early on in the drug development process; choosing the appropriate drug delivery method and novel excipients. Raw material source and judicious choice of chemistry, ultimately determine the quality of novel lipid excipients which, in turn, has a big impact on the performance, reproducibility, costs, and regulatory approval timelines. This webinar will propose solutions to maximize the probability of success while formulating RNA therapeutics and vaccines.
Participate in the interactive webinar now: https://bit.ly/2xXMZlm
Explore our webinar library: www.emdmillipore.com/webinars
We focus on providing you lab testing services that accelerate R&D intensive projects. Follow us to share & learn about analytical testing research and more.
Bioanalytical Capabilities -- Thought-Leading Science Armed with the Latest T...Covance
Helping your drug development program succeed is what we do. Keeping your timeline on track requires scientific expertise, operational experience and up-to-date knowledge of the regulatory environment. Whether you need preclinical or clinical bioanalysis, local support or global capabilities, Covance is the partner that you can trust to help deliver on your bioanalytical timelines every day, every time.
Therapure leverages its extensive experience & fully equipped analytical development control testing space to create robust and reliable analytical methods. Our expertise: Protein Characterization, Physiochemical analysis, Microbiological testing, etc.
Strand SmartLab - Enabling Precision Medicine at community HospitalsHarsha Rajasimha
Strand SmartLab is a complete soup to nuts solution that enables a community hospital to establish precision medicine testing services in-house. This enables the retention of revenues internally rather than loosing them to external third party laboratories. Genomics driven precision medicine for Cancer and other diseases require highly skilled people, lab equipment, processes, regulatory experts, bigdata software, databases and curation, medical geneticists to interpret the results in clinical settings and genetic counselors. Strand SmartLab brings all these to your institution in a pre-packaged solution.
Deputy Manager QA, working exp in beverage, juice water , sauces ketchup, mayonnaise and Jam & new product development. FSMS , HACCP & FSSC implementation& auditing
Bioanalytical Capabilities - Thought-Leading Science Armed with the Latest Te...Covance
Helping your drug development program succeed is what we do. Keeping your timeline on track requires scientific expertise, operational experience and up-to-date knowledge of the regulatory environment. Whether you need preclinical or clinical bioanalysis, local support or global capabilities, Covance is the partner that you can trust to help deliver on your bioanalytical timelines every day, every time.
T.Rama Rao is a Sr.Consultant & Promoter of M/s.Saipharma Consultancy with Team Members having rich experience in handlig Project Management, Audits & Compliance Management, Regulatory Affairs, Pharmaceutical Product Development, GxP Training/ Operational Excellence
We work with Micro ,Small ,Medium and Large Enterprises in Pharma Formulations/Intermediates ,APIs,& Chemicals / Medical Devices/ BioTech / AYUSH/ Primary Pkg Mtrs/ Clinical Research Organisation .
Please visit our web site www.saipharmaconsultants.com for further details
I am a highly motivated scientist and an effective collaborator with 10 years of Research experience in the field of Protein Biochemistry and Bio-Analytical. Experience in developing Analytical methods for Carbohydrates, Protein purification and quantitation methods, Protein characterization, formulation development and Enzyme assays for protein engineering projects. Worked closely with different functional groups across global sites to determine best practices to execute the projects. Currently leading the Analytical team to support Neutraceutical projects.
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
𝐓𝐉 𝐂𝐨𝐦𝐬 provides unlimited package services including such as Event organizing, Event planning, Event production, Manpower, PR marketing, Design 2D/3D, VIP protocols, Interpreter agency, etc.
Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬:
➢ 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH
➢ SUPER JUNIOR-L.S.S. THE SHOW : Th3ee Guys in HO CHI MINH
➢FreenBecky 1st Fan Meeting in Vietnam
➢CHILDREN ART EXHIBITION 2024: BEYOND BARRIERS
➢ WOW K-Music Festival 2023
➢ Winner [CROSS] Tour in HCM
➢ Super Show 9 in HCM with Super Junior
➢ HCMC - Gyeongsangbuk-do Culture and Tourism Festival
➢ Korean Vietnam Partnership - Fair with LG
➢ Korean President visits Samsung Electronics R&D Center
➢ Vietnam Food Expo with Lotte Wellfood
"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
India Orthopedic Devices Market: Unlocking Growth Secrets, Trends and Develop...Kumar Satyam
According to TechSci Research report, “India Orthopedic Devices Market -Industry Size, Share, Trends, Competition Forecast & Opportunities, 2030”, the India Orthopedic Devices Market stood at USD 1,280.54 Million in 2024 and is anticipated to grow with a CAGR of 7.84% in the forecast period, 2026-2030F. The India Orthopedic Devices Market is being driven by several factors. The most prominent ones include an increase in the elderly population, who are more prone to orthopedic conditions such as osteoporosis and arthritis. Moreover, the rise in sports injuries and road accidents are also contributing to the demand for orthopedic devices. Advances in technology and the introduction of innovative implants and prosthetics have further propelled the market growth. Additionally, government initiatives aimed at improving healthcare infrastructure and the increasing prevalence of lifestyle diseases have led to an upward trend in orthopedic surgeries, thereby fueling the market demand for these devices.
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RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
www.seribangash.com
Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
Premium MEAN Stack Development Solutions for Modern BusinessesSynapseIndia
Stay ahead of the curve with our premium MEAN Stack Development Solutions. Our expert developers utilize MongoDB, Express.js, AngularJS, and Node.js to create modern and responsive web applications. Trust us for cutting-edge solutions that drive your business growth and success.
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Falcon stands out as a top-tier P2P Invoice Discounting platform in India, bridging esteemed blue-chip companies and eager investors. Our goal is to transform the investment landscape in India by establishing a comprehensive destination for borrowers and investors with diverse profiles and needs, all while minimizing risk. What sets Falcon apart is the elimination of intermediaries such as commercial banks and depository institutions, allowing investors to enjoy higher yields.
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
Unveiling the Secrets How Does Generative AI Work.pdfSam H
At its core, generative artificial intelligence relies on the concept of generative models, which serve as engines that churn out entirely new data resembling their training data. It is like a sculptor who has studied so many forms found in nature and then uses this knowledge to create sculptures from his imagination that have never been seen before anywhere else. If taken to cyberspace, gans work almost the same way.
Accpac to QuickBooks Conversion Navigating the Transition with Online Account...PaulBryant58
This article provides a comprehensive guide on how to
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2. History
Founded in San
Diego by Biotech
Investment Group
2005
2009
2010
2012
2013
2015
Grown to 600
employees in Beijing
and acquired by PPD
Recipient of Pfizer’s
2010 Difference
Maker Award
Formex joins Biotech
Investment Group,
operating in a 44,000
sq. ft. cGMP facility
92,000 sq. ft.
Shanghai facility
opened to meet
growing client
demand
BioDuro reacquired
from PPD, BioDuro
and Formex merge to
enable broad range
of service offering
Overview
BioDuro
3. Overview
BioDuro
Vision: Speed development and delivery of better drugs, because PATIENTS are waiting
Mission: To be the BEST, world class drug discovery, development, and manufacturing integrated partner
of choice
Accountability
We take responsibility for our actions
and behavior at all times, and conduct
ourselves to established metrics of
high performance.
Vision, Mission, and Corporate Values
Results
We establish clear measures of
success, and deliver results to our
internal and external stakeholders.
Respect
We deeply Respect our employees
and clients, within a Family structure,
based on Equality and Understanding.
Integrity
We are honest with ourselves and
transparent in our actions, and hold
Intellectual Property (IP) standards at
the highest level.
Tenacity
We know we may face adversity, but
will never give up, but persevere to
succeed.
4. Overview
BioDuro
San Diego USA
Corporate headquarters.
Home to development and
manufacturing operations.
Size: 44,000 sq. ft.
Featured Capabilities: Tableting,
Coating, Hot Melt Extrusion, Spray
Dried Dispersion
Beijing China
Supporting discovery operations with
300 regular fume hoods and 18 scale
up hoods since 2006.
Size: 100,000 sq. ft.
Featured Capabilities: Monoclonal
Antibody Discovery,
Synthetic Chemistry
Shanghai China
Center for Integrated Drug Discovery, with
turnkey approach to medicinal chemistry,
discovery biology, and DMPK
Size: 92,000 sq. ft.,18,000 sq. ft. Vivarium
Featured Capabilities: In Vitro ADME, In Vivo
PK
Facilities
6. Overview
BioDuro
BioDuro Discovery and Development Continuum
of Services
Early
Lead
Lead
Series PDC IND NDA
Target
Identification
Target
Validation
Lead
Identification
Lead
Optimization
Preclinical
Development
First In
Man
Phase
1
Phase
2 a/b
Phase
3
Approval
▪ Feasibility Evaluation
▪ Assay Development
▪ Reference Compounds
▪ Library Design
▪ De novo Design
▪ Virtual Screen
▪ Hit Triage
▪ Hit-to-Lead
▪ Lead Optimization
▪ Medicinal Chemistry
▪ Assay Development
▪ Pre-Clinical Formulation
▪ ADME/DMPK
▪ API Development
▪ Human Dose Prediction
▪ In-vivo PK (dog, monkey)
▪ Non-GLP Tox Studies
▪ Pre-Formulation
▪ API cGMP manufacturing
▪ Formulation Development
▪ Formulation Optimization
▪ cGMP CTM Manufacturing
▪ Analytical Method Dev/Valid
▪ Release and Stability Testing
GLP Toxicology and API cGMP manufacturing outsourced to partners.
7. 12 Years
Maintaining great working
relationships with our
clients since 2005
20 compounds
A track record of 20
compounds successfully
delivered to the clinic
100% success rate
A superior record of
successful cGMP
manufacturing campaigns
1:4 PhD to Non-PhD
An industry leading staff
ratio to support quality
science
10-100 fold solubility enhancement
Formulation development expertise
that guarantees significant solubility results
The Proof is in the Data
Overview
BioDuro
9. Medicinal
Hit selection
Hit to lead chemistry
Multiple-parameter lead
optimization to Target
Product Profile
Patent preparation and filing
Chemistry
Synthetic
Organic synthesis
Bioorganic synthesis
Process discovery &
development
Parallel chemistry
Scale-up to non-GMP drug
substance
Analytical
Method development
Routine purification
Chiral separation
Impurity analysis
Thermal analysis
Particle size, shape
and crystallinity
determination
Computational
Small molecule modeling
Conformational analysis
ADME and physicochemical
property prediction
Homology modeling
Library design, enumeration and
diversity analysis
• Strong operational support for material
sourcing and compound management
• Reproducible high-quality data
• State-of-the-art equipment
The BioDuro
Advantage
Overview
BioDuro
• Responsive project management
• Broad therapeutic area expertise
10. Overview
BioDuro
Why Work With BioDuro?
People
- 350+ experienced, well-educated scientists
- 15% PhD; 50% MS; 35% BS
- On average >6 years work experience
- Excellent problem-solving skills
- Frequent, clear and transparent
communication
- Focus on delivering quality products, data
and support
Infrastructure
- Excellent infrastructure
support enables scientists
to focus on chemistry
Systems
- Effective and efficient
systems ensure smooth
logistics from project
start to finish
11. Overview
BioDuro
Our People
Group Leaders
• Typically PhD chemists with many years experience (>7 years on
average)
• Most group leaders have been with BioDuro for more than 6 years
• Lead day-to-day lab operations on their projects; design and
troubleshoot routes
• Excellent chemistry, project management and communication skills
• Almost daily interaction with clients as key point of contact
• Supervise and train ~10-20 bench chemists
Directors
• Seasoned scientists with ~10-25 years working experience
• Responsible for 3-4 clients; 4-5 group leaders; ~60 bench
chemists
• Provide scientific and managerial oversight
• Lead MedChem and Integrated projects
• Communicate directly with clients to ensure satisfaction
• Coach group leaders to become more effective leaders and
communicators
Bench Chemists
• High number of experienced chemists with many years of service
• BS - average 7 years of experience
• MS - average 5 years of experience
• PhD – average 4 years of experience
12. Overview
BioDuro
- Easy access to essential equipment in the labs
- CombiFlash or Biotage (1 per 15 chemists)
- Microwave (1 per 30 chemists)
- Prep-HPLC
- Every chemist has access to SciFinder
- Literature requests are fulfilled in less than 24 hours
- Quick turn-around times for critical services
- LC-MS – 30 min
- H-NMR – 1 h
- Prep-HPLC – 1-2 d (depends on scale)
- SFC – 1-2 d (depends on scale)
Our LabsWell-equipped modern labs in Beijing and Shanghai
(500 fume hoods)
13. Overview
BioDuro
- Provides both analysis and purification support for all projects
- Method development
- Maintain instruments
- Open-access systems, train chemists
- Purification including chiral separation
- 12 x LC-MS (Agilent, Shimadzu)
- 22 x HPLC/UPLC (Agilent, Shimadzu, Waters)
- 6 HPLC/UPLC for purity determination
- 6 HPLC for method development
- 6 prep-HPLC purification systems (3 MS-triggered)
- 2 large scale prep HPLC systems – up to 10 g/day/instrument
- 2 chiral HPLC - 0.5-2 g/day
- 2 x SFC (Thar): Analytical X5 & Prep-80 – 1-5 g/day
- GC-MS (Shimadzu)
- 4 x NMR (2 Varian, 2 Bruker)
Analytical Chemistry & Purification
14. Overview
BioDuro
Services Key Equipment
• Scale up services (up to 5 kg)
• Synthesis of intermediates, building blocks,
references, metabolites, impurities
• Synthesis of non-GMP tox and clinical materials
• Process Discovery and Development
• Optimization of reaction conditions
• Route discovery, selection and development
• Development of robust and scalable route
• Pilot Production and Manufacturing (with Partners)
• Synthesis of non-GMP intermediates and API
• 20 hoods including 8 large walk-in rooms and
5 large walk-in hoods
• 2L - 100L Reactors
• 50L Separatory flasks
• 20L Evaporators
• DSC (TA, Q20)
• Drying ovens
Scale-up Chemistry
20. Overview
BioDuro
Our Team Our Leadership Our Quality
Overview
Our well established team
consists of scientists skilled in
the following areas:
▪ Bioanalysis
▪ In vitro ADME
▪ In vivo PK
▪ Vivarium Management
A group of respected experts
in drug discovery and
development with an average
of 8-15 years experience
working at CROs and
Universities.
Committed to highest
standards of quality and to
exceeding customers
expectations.
All client reports undergo
quality control by group
leaders and quality will be
assured by study directors.
21. Overview
BioDuro
Services
In Vitro ADME
• Physicochemical properties
• In vitro drug metabolism
• Permeability measurement
• Drug-Drug Interaction
In Vivo PK
• Tissue distribution studies
• Metabolite identification and quantification
• Formulation development
• In-life dosing and sampling
• Bioanalytical method development; bioanalysis
DMPK
Capabilities
PO, IV, SC, IP, IN; IV/PO cassette
dosing
Multiple dosage routes
Multiple cannulation models
Liver microsome/hepatocyte stability
CYP phenotyping
Metabolite ID (phase I and II)
Caco-2
PAMPA
CYP inhibition assay
Time dependent inhibition
GSH trapping assay
Overview
BioDuro
22. Overview
BioDuro
In vitro ADME Bioanalysis
Capabilities
- Physicochemical properties
- logD
- Solubility
- Permeability (PAMPA , Caco-2)
- In vitro drug metabolism
- Stability in microsomes,
hepatocytes, solution, plasma,
blood, etc.
- Metabolite Profiling and
Identification (Phase I and
Phase II)
- Drug-Drug Interaction Profiling
- Cyp phenotyping
- Cyp inh. / time-dependent inh.
- Plasma and Tissue Protein
Binding
- Bioanalytical method
development; bioanalysis
- HPLC or LC-MS/MS for
Small Molecule
- LC-MS/MS for
peptide/protein
- ELISA for
protein/antibody, ADC
Others
- PK/PD Studies
(Oncology and
metabolic disease)
- In Vivo/In Vitro
Correlation Analysis
- IND-enabling Studies
for CFDA
In vivo PK
- Rodent PK
- Rodent Tissue Distribution
- Dog/Monkey PK
- Exploratory Safety in
Rodent/Dog/Monkey
- Metabolite identification and
quantification
- Formulation development
- In-life dosing and sampling
- PO, IV, SC, IP, IN;
- IV/PO cassette dosing
- Multiple dosage routes
- Multiple cannulation models
23. Overview
BioDuro
Equipment and Facilities
The BioDuro Advantage
Vivarium
AAALAC accredited vivarium (1,500 sq. m) for rodent
PK/tissue distribution and dog PK studies
Small animal room (rodents): SPF; Dog animal room:
conventional
Internal Institutional Animal Care and Use Committee (IACUC)
-internal and external experts
Review SOPs; Review and approve protocol; Monitor animal
use and welfare
Instruments
Total of 8 LC-MS/MS systems
2 API-5500; API-4000Qtrap; API-4500Qtrap and 4 API-
4000; Typical LOQ: 1 nM or lower
2 UPLCs - Shimadzu LC-30AD and Waters H-class
We take great pride in adhering to strict
regulatory standards and work in a
professional GLP like environment.
We maintain a high quality AAALAC
accredited vivarium and run our studies on
quality controlled instruments.
BioDuro is strongly committed to ensuring
the welfare of animals used in our research.
We treat the animals we use humanely, and
adhere to strict standards of care and ethical
principles in providing for their welfare.
26. Overview
BioDuro
Animal Models for Metabolic Disease
- High fat diet induced obese (DIO) rats/mice
- Streptozotocin (STZ) induced type 1
diabetic rats/mice
- High fat diet (HFD) + STZ induced type 2
diabetic rats/mice
- KKAy mice with NASH, retinopathy,
nephropathy
- ob/ob and db/db mice
- GK (Goto-Kakizaki ) rats
- ApoE KO mice
- Myocardial infarction and reperfusion injury
in rats/mice
- Renal ischemia and reperfusion injury in
rats/mice
27. Overview
BioDuro
Animal Models for Immunology and Inflammation
Cytotoxic T cell (CD8+)
Helper T cell (CD4+)
Reg/Supp T cell (CD4+ CD25+)
Memory T cell
Deposition of Immuno-complex
Cytokines secretion
Eosinophil apoptosis
IgE production
Immune suppressor
T-Cell as Target B-Cell as Target Cytokines as Target Others
- Systemic Lupus Erythematosus
- Rheumatoid Arthritis
- Type I Diabetes
- Experimental Autoimmune
Encephalomyelitis
- Inflammatory Bowel Disease
- Atopic Dermatitis
- Psoriasis
- Type IV hypersensitivity
- Systemic Lupus Erythematosus
- Rheumatoid Arthritis
- Type I Diabetes
- Experimental Autoimmune
Encephalomyelitis
- Inflammatory Bowel Disease
In vivo Models:
- Rheumatoid Arthritis
- Inflammatory Bowel Disease
- Psoriasis
- Asthma
- Type IV hypersensitivity
TNFα;
IL-1;
IL-17; IL-17R
IL-6; IL-6R;
IL-12/23;
Memory B cell
Follicular B cell
Marginal Zone B cell
Reg/Supp B cell
Deposition of Immuno-complex
Plasma Blast
Plasma Cell INFγ; IL-4
IL-12; IL-2 Histamine receptor
mTOR
- LPS Induced Cytokine Secretion
- Concanavalin Induced Cytokine
Secretion
- Asthma
- Atopic Dermatitis
- Rheumatoid Arthritis
28. Overview
BioDuro
Multiple Sclerosis Intestinal Bowel
Disease
Rheumatoid Arthritis
Animal Models for Immunology and Inflammation
- MBP-induced
EAE in Lewis
rats
- PLP-induced
EAE in SJL/J
mice
- MOG35-55
induced EAE in
C57BL/6 mice
- DSS-induced
colitis in
C57BL/6 mice
- DSS-induced
colitis in rat
- Collagen-Induced
arthritis (CIA) in
DBA/1 mice
- Collagen-induced
arthritis (CIA) in
Lewis rats
- Adjuvant-Induced
arthritis(AIA)in
Lewis rats
- G6PI-induced
arthritis in DBA/1
Mice
Asthma
- OVA-induced
asthma in mice
29. Overview
BioDuro
Systemic lupus Erythematosus (SLE)
- Pristane-induced lupus in mice
- MRL/lpr mice
Animal Models for Immunology and Inflammation
Delayed Type Hypersensitivity (DTH)
- Oxazolone-induced DTH in mice
Psoriatic Model
- Imiquimod-induced psoriasis in mice
FITC Induced Dermatitis
- FITC-induced dermatitis in mice
LPS-induced Acute Inflammation
- LPS-induced cytokine secretion in mice
- LPS-induced acute lung inflammation in
BALB/c mice
Concanavalin A-Induced Cytokine Secretion
- Concanavalin A - induced cytokine
production in Lewis rats and mice
The BioDuro
Advantage
Extensive drug discovery and development experience
enabling support of fully integrated programs, including
study design and data interpretation. Special expertise in
metabolic and inflammatory diseases is coupled with a
commitment to working with clients to develop
customized models for rare diseases.
32. Overview
BioDuro
Services
Oncology therapeutic target discovery and validation
Compound and biologics efficacy and early safety
evaluation
Consultation
Oncology drug discovery
Oncology
Capabilities
Cellular model based assays
• 2D culture, 3D spheroid culture, hTME-3DX Screen and Verify™
Cancer animal models
• CDX
• PDX
Immuno-oncology
• Syngeneic mouse model
• Humanized immunity system model
Overview
BioDuro
33. Overview
BioDuro
In Vivo Models
- CDX: Cancer cell line
derived xenograft
models (>220 lines and
64 validated models)
- PDX: Patient-derived
xenograft models
- Syngeneic mouse
tumor models (for
cancer immunotherapy)
- Subcutaneous tumor
models
- Orthotopic tumor
models (breast, liver
and lung cancer)
- Experimental
metastatic tumor
models
- Systemic leukemia,
lymphoma and multiple
myeloma models
- Tumor growth
inhibition (TV, TW,
Luciferase based in
vivo imaging)
- Tumor growth delay
- General toxicity (BW,
animal behavior
observation)
- PK/PD, Histology,
Down-stream signaling
(qRT-PCR, Western
blot, FACS)
34. Overview
BioDuro
In Vitro Assays
- Drug target
expression: RT-PCR,
Western Blot, IHC,
FACS
- Drug target validation:
Gene over-expression
and knockdown
Drug efficacy evaluation
- Enzyme activity:
ELISA, Biochemistry
assay
- 2D and 3D culture
(hTME-3DX Screen
and Verify™, Low
adherence/spheroid)
- Cell proliferation:
MTS, CTG, BrdU
- Cell-based assays:
Apoptosis, Migration
& invasion
- Histology staining:
Paraffin blocks
preparation, H&E, IHC
35. Overview
BioDuro
Advanced Models for Human Cancer:
hTME-3DX Screen and Verify™
hTME-3DX
Screen and
Verify
Patient-Derived
Xenograft (PDX)
PDX Surrogacy, In vitro - In
vivo Companion, Fine Tuning
MoA and Pharmacology
Greatest Patient Diversity, Lower Autocrine
Bias, Higher Throughput, Time & Cost
Savings
• Human Tumor Cells
• Murine ECM (Human TME
Alignment)
• Humanized TME
• Human Tumor Cells
• Murine ECM
• Murine TME
Better Patient Diversity (vs. CDX),
PK/PD Studies, Broader MoA
36. Overview
BioDuro
Advanced Modeling for Human Cancer:
High Take-rate in Humanized TME
*Molecular Response, LLC 2016; ✝Siolas & Hannon 2013 Cancer Res;✧Dangles-
Marie, et al. 2007 Cancer Res and Gillet, et al. 2013 JNCI
Patient 3DX-TGA PDX; CDX Cell Culture
CRC
Breast
Ovarian
GI
Lung
CNS
HCC Panc
Bladder
> 95%* 23-75%✝ 10-50%✧
Loss of paracrine
dependent tumors
Selection bias to
autocrine tumors
Murine TMEHumanized TME Limited TME
Humanized Tumor
Microenvironment
TumorMicroenvironment(TME)
Superior Pharmacogenomics (PGx)
38. Overview
BioDuro
Immuno-oncology
- PBMC, B, T and NK cell
isolation
- T and NK cell activation
and proliferation
- Immune-phenotyping
with multi-color FACS
- Immunocytes and
cytokine infiltration
assay in 3D tumor cell
spheroids
- Multiplex cytokine
analysis, MSD
- PBMC or NK cell
mediated toxicity
- Antibody dependent
cell-mediated
cytotoxicity assay with
multiple assay formats
- Syngeneic mouse
model and humanized
immunity system model
39. Overview
BioDuro
Integrated Drug Discovery at BioDuro
The BioDuro Advantage
All major discovery functions in Shanghai for
single site execution
Enhanced program communication and
reduced cycle times
Seamless transfer of programs to San Diego
for formulation and IND study support
Reliable external partners ready to
supplement our core expertise
- Integrated with client
- Functions at one site
- Minimize cycle times
In vitro
DMPK;
in vivo PK
Program
Management
Formulation
Development
Analytical
Services
In Vivo
Pharmacology
Biology, Assay
Development
Medicinal
Chemistry
SBDD
Computational
Chemistry
Fragment
screening
X-ray
crystallography
GPCR
screening
42. Overview
BioDuro
Pre-Formulation
Physical, chemical and biological
characterization
Using drug attributes to predict the best formulation approach:
Aqueous solubility (pH dependent)
Solvent/oil solubility
Thermal stability
Polymer miscibility/interaction
Partitioning (logP, logD)
Particle size
Excipient compatibility
43. Overview
BioDuro
Overview
BioDuro
Formulation Development
Formulation Solution Engine
Drug characteristics drive development choices
Custom solutions platform enables rapid development
Understanding Delivery Needs
Improving solubility, maximizing stability, engineering rate and location of drug
release
Full use of technologies such as Spray Dried Dispersion, Hot Melt Extrusion,
Coating, Matrix tablets, etc.
Lead prototype identification, scale-up and technology transfer to manufacturing,
overseen by formulations scientists
44. Overview
BioDuro
Examples of Recent
Formulations Developed
Patent Application for Oral
Protein Delivery Filed
Patent Application for
Gastroretentive
Formulation Filed
Formulation Development: Key Experience
- Standard oral formulations
- Amorphous dispersion
based formulations
(SDD/HME)
- Controlled release dosage
forms
- Coated
tablets/capsules/particulates
- Matrix/gelling tablets
- Dissolution controlled
particulates
- Topical formulations
- Oral protein formulations
- High activity retention after
processing
- Protection from denaturing
conditions
- High activity density
45. Overview
BioDuro
Solubility Enhancement Techniques
Amorphous Dispersion Feasibility
• <.05 g of API
• MicroEvap Processing- PreClinical Solubilization
• Small samples for Discovery/Early Development
• Screen Excipients for SDD, HME
Amorphous Dispersion Development/Scale-Up
• 5+ g of API, 100g-500g Dispersion
• HME (Leistritz Nano 16mm or ZSE
18mm)
• SDD (Anhydro MS-35 and MS-150)
API Availability
Discovery (Selection), Early Tox, Early Preclinical
Candidate
• 0.5-5 g of API, 2g-10g of Dispersion
• MiniExtrusion with Haake MiniCompounder
• MiniSDD with Buchi Nano B90, B290 Spray
Dryer
46. Overview
BioDuro
Data-Driven Drug Development : The BioDuro Advantage
Solutions
• Melting Point
• Crystallinity
• Solubility
• Aqueous
• Micelles
• Solvent
• Solvent Stability
• Thermal Stability
• Powder Flow
• Max. Absorbable Dose
• Max. Tolerated Dose
• Permeability/Efflux
• Absorption Window
• Relative Bioavailability
• Pharmacokinetics
• Dose Format
• Tablet/Capsule/Other
• Solubilization Approach
• Nanosuspension
• Amorphous API
• Solution
• Controlled Release Approach
• Enteric Coating/Matrix
• Matrix Disso Rate
• Release Profile (Cmax,Tmax)
• Dose Limits
• Bolus Delivery/Permeability
Enhancement
Final Dosage Form
Pre-FormulationData
Chemical/PhysicalBiological
ISSUES
• Dosage Form for Best
Compliance
• Solubility Limits BA
• Stability in GI Tract
• Narrow Therapeutic Window
• GI Regional Absorption
• Poor Permeability
47. Overview
BioDuro
Analytical expertise that drives sound formulation and process
development decisions
Analytical methods developed
compatible with formulation
properties
Analytical Chemistry
Timely release testing of
manufactured clinical trial material
Seamless transfer of robust
methods, and validated in phase-
appropriate manner
ICH compliant stability
monitoring to ensure product
quality
Flexible teams supporting stand-
alone, and fully integrated projects
48. Overview
BioDuro
- Provides analytical support through continuum of
services for discovery and development
- Purification
- Compound Characterization
- Process Scale Up
- cGMP Manufacturing
- Release and Stability Testing
- Key Analytical Equipment
- LC-MS (Agilent, Shimadzu)
- HPLC/UPLC (Agilent, Shimadzu, Waters) including Prep-
HPLCs and Chiral HPLC
- SFC (Waters Thar)
- GC-MS (Shimadzu) and GC (Agilent)
- NMR (2 Varian, 2 Bruker)
Global Analytical Chemistry Capabilities
49. Overview
BioDuro
Analytical Chemistry
The BioDuro Advantage
Close integration with formulation
development, process development
and manufacturing teams for
coordinated and timely analytical
support throughout the entire
program.
Analytical Development
Method evaluation
Method optimization
Method transfer
Method development
Phase-appropriate method validation
Stability/QC testing
Release testing of raw materials
Release and stability testing of drug product/CTM
In-process testing during manufacturing
Stability program management, testing and storage
Cleaning verification
50. Overview
BioDuro
cGMP Manufacturing
High quality clinical trial material
manufacture through Phase III
Dosage Forms
Tablets
Capsules
Beads, Pellets and Granules
Oral Liquids
Topicals
API in a capsule (Xcelodose®)
Final Product Packaging and Labeling
CTM Storage and DistributionHot Melt Extrusion
Spray Dried Dispersion
Roller Compaction
Pan Coating and Wurster Coating
Granulation (wet, dry, high shear)
Fluid Bed Drying
Milling Blending, Compression
Encapsulation
Process Technologies
Packaging, Labeling, Distribution
51. cGMP Manufacturing
The BioDuro Advantage
Seamless transfer of formulation
knowledge from development to scale-up
to GMP manufacturing
Flexible and reliable manufacturing
operations designed to customize
production according to client needs
Transparency and open communication
with clients during manufacturing
Engage at process development or directly to GMP manufacturing
Scalable and mobile equipment for 9 manufacturing suites
Formulation scientists in the suites during production
In suite process observation by clients
Real time status updates from technical/project lead
Compliance oversight by experienced QA auditors
52. Overview
BioDuro
Project Management Quality Assurance
Supporting Functions
Drive project initiation process
Define and monitor project timelines
Provide weekly or biweekly project updates
Management of project scope and budget
One primary communication contact
Coordination of activities
Risk management
Conflict resolution and escalation of issues
Review of cGMP documentation
Employee training
Conduct internal audits
Hosting regulatory and client audits
Vendor management programs
Creation, review and approval of SOPs
Change control management
Quality metrics
53. Overview
BioDuro
Integrated Drug Development at BioDuro
All functions in San Diego for single site
execution
Product and process development know-
how maintained at single CRO
Seamless and efficient transfer from pre-
formulation to CTM manufacturing, from
preclinical through to Phase 3
- Integrated with client
- Integrated internally
within teams
Program
Management
Pre-
formulation
Formulation
Development
Analytical
Development
Engineering
batch
manufacturing
cGMP CTM
manufacturing
Release and
stability
testing
Packaging and
Distribution
The BioDuro Advantage
54. Experienced and Client Focused
Broad range of scientific backgrounds
Scientists as project leads providing real time updates
Effectively use project management system and tools
Adherence to top scientific and strict quality standards
Effective collaboration and teamwork across departments
Responsive and flexible to meet client needs
Our team
Overview
BioDuro
55. San Diego USA Beijing China Shanghai China
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