The key technological advances in assay development in recent years have been the use of magnetic microspheres and polymer beads as the solid phase in automated immunoassays. This has enabled automation, faster reactions, increased sensitivity, and shorter assay times. Magnetic beads and polymer beads allow assays to work in three dimensions, dramatically increasing surface area and sensitivity compared to traditional ELISAs or coated tubes. IVD manufacturers must consider factors like accuracy, reproducibility, stability, and ease of adaptation when developing assays for instrument systems. Forming collaborations with academic researchers is important for assay development to help discover new biomarkers and opportunities to add new tests.
- Neusentis is a regenerative medicine subsidiary of Pfizer focused on developing cell-based therapies.
- Their portfolio includes collaborations on stem cell-derived retinal pigment epithelial (RPE) cells to treat macular degeneration, and allogenic adult multipotent stem cells to treat inflammatory bowel disease.
- Major challenges for developing and commercializing cell therapies include cell biology and manufacturing complexities, rigorous clinical trial design and supply logistics, and demonstrating a clear business case for pricing and reimbursement.
This document discusses Neofluidics, a company developing microfluidic technology to improve drug discovery and medical diagnostics. It summarizes that current well plate technology is over 50 years old, inefficient, and costly. Neofluidics' microfluidic chips provide more efficient workflows by reducing sample and reagent volumes by up to 99%, eliminating large capital costs, and facilitating point-of-care testing. The document outlines the opportunities in drug screening, diagnostics markets and Neofluidics' progress in developing and commercializing its technology.
DCN Diagnostics offers OEM development services for complete lateral flow diagnostic systems. They have expertise in assay development, product engineering, manufacturing process development and commercialization assistance. Their services include reagent development, assay design, reader integration, design of plastic cassettes and cartridges, and manufacturing transfer. DCN has experience across various industries like medical diagnostics, veterinary, food testing, and can develop qualitative or quantitative lateral flow assays.
Lateral flow assays are the most robust, mature immuno sensor available today. Performance in some applications has historically been limited by difficulties in multiplexing and quantification. Novel approaches have been developed and commercialized in recent years that allow for the development and manufacturing of highly multiplexed arrays in lateral flow assays. The patented Symbolics (tm) approach is one such methodology. Symboics (tm) allows for the creation of arrays in lateral flow fields that develop evenly, allowing in turn for the creation of highly complex features such as letters and symbols and also allows for creation of multiplex assays with advanced features such as internal controls. This presentation introduces the principles of multiplexed arraying and the Symbolics technology
This document summarizes PCT's vision and history as a leader in cell therapy manufacturing. PCT aims to make transformative cell-based therapies accessible to all through providing high-quality and scalable manufacturing services. Over 30 years, PCT has gained unprecedented expertise manufacturing over 20 cell therapy products and treating over 6,000 patients. PCT partners with companies from start-ups to large pharmaceutical companies, and aims to guide clients through the entire development and manufacturing process.
1b fe inscore sr research scientist resume 2019inscore
Frank Inscore has over 15 years of experience as a senior research scientist and analytical spectroscopist with expertise in spectroscopy, characterization, analysis, and chemistry. He has managed research projects and labs, published scientific papers, and led teams developing new materials and products. Currently he works as an independent consultant on various contracts involving nanomaterials.
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
This document summarizes a presentation given by Merck KGaA on post-approval changes for biologics manufacturing from a supplier's perspective. It discusses the challenges of post-approval changes, including unclear regulations and high regulatory burden. It provides examples of how suppliers can help customers justify lower risk categorizations for changes through comparative studies, improved analytics, and collaboration on change management protocols. The presentation aims to demonstrate how suppliers and customers can work together to make post-approval changes more efficient.
A Molecule’s Journey – Breaking Down Roadblocks to Commercial SuccessMilliporeSigma
Every biopharma executive must make important decisions early in clinical development that will impact their molecule’s journey – and ultimately the success of their commercial strategy. The key to this success is to make the right decisions at the right time. In this webinar, our experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety. To achieve this goal, companies must navigate the complexities associated with business planning, cell line development, process development, technology, and regulatory and risk assessment.
In this webinar, you will learn:
- Key business considerations for commercial success
- Key technical considerations
- Regulatory and risk assessment considerations
- Neusentis is a regenerative medicine subsidiary of Pfizer focused on developing cell-based therapies.
- Their portfolio includes collaborations on stem cell-derived retinal pigment epithelial (RPE) cells to treat macular degeneration, and allogenic adult multipotent stem cells to treat inflammatory bowel disease.
- Major challenges for developing and commercializing cell therapies include cell biology and manufacturing complexities, rigorous clinical trial design and supply logistics, and demonstrating a clear business case for pricing and reimbursement.
This document discusses Neofluidics, a company developing microfluidic technology to improve drug discovery and medical diagnostics. It summarizes that current well plate technology is over 50 years old, inefficient, and costly. Neofluidics' microfluidic chips provide more efficient workflows by reducing sample and reagent volumes by up to 99%, eliminating large capital costs, and facilitating point-of-care testing. The document outlines the opportunities in drug screening, diagnostics markets and Neofluidics' progress in developing and commercializing its technology.
DCN Diagnostics offers OEM development services for complete lateral flow diagnostic systems. They have expertise in assay development, product engineering, manufacturing process development and commercialization assistance. Their services include reagent development, assay design, reader integration, design of plastic cassettes and cartridges, and manufacturing transfer. DCN has experience across various industries like medical diagnostics, veterinary, food testing, and can develop qualitative or quantitative lateral flow assays.
Lateral flow assays are the most robust, mature immuno sensor available today. Performance in some applications has historically been limited by difficulties in multiplexing and quantification. Novel approaches have been developed and commercialized in recent years that allow for the development and manufacturing of highly multiplexed arrays in lateral flow assays. The patented Symbolics (tm) approach is one such methodology. Symboics (tm) allows for the creation of arrays in lateral flow fields that develop evenly, allowing in turn for the creation of highly complex features such as letters and symbols and also allows for creation of multiplex assays with advanced features such as internal controls. This presentation introduces the principles of multiplexed arraying and the Symbolics technology
This document summarizes PCT's vision and history as a leader in cell therapy manufacturing. PCT aims to make transformative cell-based therapies accessible to all through providing high-quality and scalable manufacturing services. Over 30 years, PCT has gained unprecedented expertise manufacturing over 20 cell therapy products and treating over 6,000 patients. PCT partners with companies from start-ups to large pharmaceutical companies, and aims to guide clients through the entire development and manufacturing process.
1b fe inscore sr research scientist resume 2019inscore
Frank Inscore has over 15 years of experience as a senior research scientist and analytical spectroscopist with expertise in spectroscopy, characterization, analysis, and chemistry. He has managed research projects and labs, published scientific papers, and led teams developing new materials and products. Currently he works as an independent consultant on various contracts involving nanomaterials.
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
This document summarizes a presentation given by Merck KGaA on post-approval changes for biologics manufacturing from a supplier's perspective. It discusses the challenges of post-approval changes, including unclear regulations and high regulatory burden. It provides examples of how suppliers can help customers justify lower risk categorizations for changes through comparative studies, improved analytics, and collaboration on change management protocols. The presentation aims to demonstrate how suppliers and customers can work together to make post-approval changes more efficient.
A Molecule’s Journey – Breaking Down Roadblocks to Commercial SuccessMilliporeSigma
Every biopharma executive must make important decisions early in clinical development that will impact their molecule’s journey – and ultimately the success of their commercial strategy. The key to this success is to make the right decisions at the right time. In this webinar, our experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety. To achieve this goal, companies must navigate the complexities associated with business planning, cell line development, process development, technology, and regulatory and risk assessment.
In this webinar, you will learn:
- Key business considerations for commercial success
- Key technical considerations
- Regulatory and risk assessment considerations
Analytical Science 5th Symposium Programme Registration Form (singlepages)?Graham Sithole?
The document is a program for the 5th Mintek Analytical Science Symposium taking place on October 30th, 2015 at Mintek in South Africa. The morning session will cover topics like celebrating 20 years of ISO17025 accreditation at Mintek and developments in guidance for using reference materials. The afternoon session will discuss root cause analysis, comparing analytical data from multiple laboratories, and applications of technologies like Fourier transform infrared spectroscopy.
Leveraging Data to Develop, Execute and Exceed the Expectations of Your Regu...April Bright
Scientific data, homegrown or from published literature, is essential to your regulatory strategy…be it establishing substantial equivalence in FDA 510(k) applications, qualifying a device as a legitimate predecessor in the context of a Technical File for CE Mark, predicting the performance of a device in development, judging a new device in verification and validation testing and, with proper planning, expanding indications for use and identifying new marketable claims of performance (or mitigation of risk and liability). In this session, participants will be exposed to various vital data sources and obtain practical examples for putting them to meaningful use.
Medax SRL is an Italian company that specializes in the production of biopsy needles and devices. The company aims to be a global provider and partner for its customers' biopsy needs. Medax offers a broad portfolio of soft tissue and hard tissue biopsy needles and devices to meet the requirements of various biopsy procedures. It prides itself on its in-house design, manufacturing, and customization capabilities.
Solutions that Integrate – BioCompatic: A Robust USP Class VI Silicone Altern...NorthwireCable
This White Paper from cable engineering company Northwire, Inc. and precision cable connector leader LEMO, discusses BioCompatic - their new, durable USP Class VI alternative to the silicone jacketed cable. Ideal for use in medical applications and beyond, BioCompatic highlights R&D advancements and next-generation technology offered by LEMO and Northwire in their pursuit of 100% reliability, extended life cycle, and safety in cables and connectors.
Program - 3rd Annual Drug Delivery and Formulation Summit 2013, San DiegoMark Blendheim
This document provides an agenda for a pharmaceutical development program taking place from April 30th to May 1st 2013 in San Diego, USA. The agenda includes:
- Welcome addresses and presentations on overcoming the patent cliff and improving clinical trial timelines on day 1
- Interactive workshops on oral drug delivery techniques and first-in-human formulation strategies
- Presentations on academic-government partnerships in nanotechnology and biologics development
- Panel discussion on improving development relationships and reducing costs and risk
- Additional presentations and workshops on topics including biologics modeling and simulation, enhancing solubility through micronization, and process validation.
LiquiLume Diagnostics develops molecular diagnostic devices that can detect individual molecules rapidly and inexpensively. Their initial focus is on nucleic acid testing (NAT) and protein biomarkers. They plan to first sell to research laboratories for research use only, then pursue FDA clearance to sell to clinical labs and hospitals. Their technology allows highly automated sample processing and analysis at low concentrations and low cost compared to standard methods.
The document discusses Thermo Scientific's leadership in serving science through analytical instruments, equipment, reagents, software and services. It highlights the company's size and scale, unmatched capabilities, portfolio of leading brands, and mission to make the world healthier, cleaner and safer. Key strengths include global industry leadership, ability to continuously invest in growth opportunities through R&D, and an excellent track record of financial performance. New products are presented for applications such as sample preparation, analysis, and data interpretation.
This document provides an overview of Anteo Diagnostics and their nanotechnology applications. Anteo has developed a patented nanoglue technology called Mix&Go that can bind biological molecules to synthetic surfaces. They are applying this technology in four business areas: 1) in vitro diagnostics and life sciences markets, 2) bioseparations, 3) medical devices, and 4) batteries. For each area, Anteo's nanoglue can improve functionality, sensitivity, and cost efficiency. The document outlines Anteo's revenue generation process, partnership achievements, and the vast potential of their drop-in nanotechnology.
The Life Science Product Manager's Toolkitprothenberg
A discussion about market research tools that can optimize each stage of the new product development process. Prepared by BioInformatics LLC exclusively for life science product and marketing managers.
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...MilliporeSigma
Are you ready to accelerate biosafety testing?
The pressure to shorten delivery times and reduce costs for biologics such as mAbs are driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. These traditional testing methods are often culture based and can take several weeks to produce the required result to allow for batch release. In this talk we will explore how new methods can be used to accelerate biosafety testing today, as well as how they can evolve to meet new manufacturing paradigms such as continuous processing and novel cell and gene therapy treatment modalities.
Participate in the interactive webinar now: http://bit.ly/BlazarWebinar
Explore our webinar library: www.emdmillipore.com/webinars
Autologous and Allogeneic Cell Therapy Industrialisation – Overcoming Clinical Manufacturing Hurdles Early
A presentation by Chief Operating Officer, Dr Stephen Ward
1) Anteo Diagnostics will partner with Atomo Diagnostics to develop a rapid blood test for early detection of heart attacks using Anteo's coating technology and Atomo's AtomoRapid platform.
2) Atomo received $100,000 in funding from the Advance Queensland Johnson & Johnson Innovation QuickFire Challenge to create a proof of concept for their rapid heart attack test.
3) If the proof of concept is successful, Atomo and Anteo will consider fully commercializing an AtomoRapid-based cardiac troponin test, which could improve on current tests in the large and growing $350 million point-of-care cardiac biomarkers market.
Memsift news focus article for membrane technolgy oct 2020 (1) (1)Antony Prince
Memsift Innovations has entered into an agreement with the Connecticut Center for Applied Separations Technologies (CCAST) at the University of Connecticut. This agreement will enable Memsift to explore application studies and pilot trials for its brine treatment and zero liquid discharge technologies in North America. The CEO of Memsift sees this agreement as an important steppingstone to enter the North American market by bringing its cutting-edge technologies to potential customers through CCAST's testing facilities.
This document summarizes a presentation given by Dr. Robert Boorstein on drivers of change in the laboratory market. Five key trends are discussed: laboratory consolidation, growth of central laboratories vs point-of-care testing, new delivery models, new technologies, and increased competition across sectors. Laboratory consolidation is driven by cost reductions and allows for standardization but may shift market power from sellers to buyers. Point-of-care testing is growing rapidly but poses challenges to quality control. New national laboratory companies are emerging focused on unique branded products.
Dr. Adrian Stevens received his Ph.D. in computational chemistry from the University of Portsmouth. He has since worked for 9 years at a contract research organization specializing in small molecule discovery research and collaborated with pharmaceutical companies. Following a brief time at another company, he joined Accelrys in 2008 and is now a Senior Product Marketing Manager responsible for the Discovery Studio product.
QIAGEN exceeded its goal of placing over 750 of its QIAsymphony modular laboratory automation systems in 2012, up from over 550 in 2011. The company expects placements to exceed 1,000 by the end of 2013. Approximately 70% of placements so far have been with molecular diagnostics customers. QIAsymphony offers integrated sample processing and real-time PCR and gives customers access to commercial assays while allowing custom tests.
Medvantage International has acquired rights to a new vascular coupling device called CUVASLAR that represents an alternative to manual suturing for connecting arteries and veins. The device is expected to reduce surgical time, minimize errors from suturing, and improve patient outcomes. Medvantage plans to submit the device for FDA approval over the next year and market it to the 340,000 microsurgery procedures performed annually in the US.
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
Major developments in point-of-care (POC) testing were highlighted at the 2015 American Association of Clinical Chemistry Annual Meeting:
1) Several companies announced new POC devices, including a low-cost, battery-powered molecular diagnostics platform from Cepheid and a smartphone-based chlamydia test.
2) Existing POC tests for influenza, diabetes, kidney disease, liver disease, and pregnancy from companies like Alere, DiaSys Diagnostics, and Abbott were demonstrated.
3) The large POC diagnostics market, estimated at $17 billion globally, was a focus for many exhibitors given the potential for rapid results at the point of care.
Analytical Science 5th Symposium Programme Registration Form (singlepages)?Graham Sithole?
The document is a program for the 5th Mintek Analytical Science Symposium taking place on October 30th, 2015 at Mintek in South Africa. The morning session will cover topics like celebrating 20 years of ISO17025 accreditation at Mintek and developments in guidance for using reference materials. The afternoon session will discuss root cause analysis, comparing analytical data from multiple laboratories, and applications of technologies like Fourier transform infrared spectroscopy.
Leveraging Data to Develop, Execute and Exceed the Expectations of Your Regu...April Bright
Scientific data, homegrown or from published literature, is essential to your regulatory strategy…be it establishing substantial equivalence in FDA 510(k) applications, qualifying a device as a legitimate predecessor in the context of a Technical File for CE Mark, predicting the performance of a device in development, judging a new device in verification and validation testing and, with proper planning, expanding indications for use and identifying new marketable claims of performance (or mitigation of risk and liability). In this session, participants will be exposed to various vital data sources and obtain practical examples for putting them to meaningful use.
Medax SRL is an Italian company that specializes in the production of biopsy needles and devices. The company aims to be a global provider and partner for its customers' biopsy needs. Medax offers a broad portfolio of soft tissue and hard tissue biopsy needles and devices to meet the requirements of various biopsy procedures. It prides itself on its in-house design, manufacturing, and customization capabilities.
Solutions that Integrate – BioCompatic: A Robust USP Class VI Silicone Altern...NorthwireCable
This White Paper from cable engineering company Northwire, Inc. and precision cable connector leader LEMO, discusses BioCompatic - their new, durable USP Class VI alternative to the silicone jacketed cable. Ideal for use in medical applications and beyond, BioCompatic highlights R&D advancements and next-generation technology offered by LEMO and Northwire in their pursuit of 100% reliability, extended life cycle, and safety in cables and connectors.
Program - 3rd Annual Drug Delivery and Formulation Summit 2013, San DiegoMark Blendheim
This document provides an agenda for a pharmaceutical development program taking place from April 30th to May 1st 2013 in San Diego, USA. The agenda includes:
- Welcome addresses and presentations on overcoming the patent cliff and improving clinical trial timelines on day 1
- Interactive workshops on oral drug delivery techniques and first-in-human formulation strategies
- Presentations on academic-government partnerships in nanotechnology and biologics development
- Panel discussion on improving development relationships and reducing costs and risk
- Additional presentations and workshops on topics including biologics modeling and simulation, enhancing solubility through micronization, and process validation.
LiquiLume Diagnostics develops molecular diagnostic devices that can detect individual molecules rapidly and inexpensively. Their initial focus is on nucleic acid testing (NAT) and protein biomarkers. They plan to first sell to research laboratories for research use only, then pursue FDA clearance to sell to clinical labs and hospitals. Their technology allows highly automated sample processing and analysis at low concentrations and low cost compared to standard methods.
The document discusses Thermo Scientific's leadership in serving science through analytical instruments, equipment, reagents, software and services. It highlights the company's size and scale, unmatched capabilities, portfolio of leading brands, and mission to make the world healthier, cleaner and safer. Key strengths include global industry leadership, ability to continuously invest in growth opportunities through R&D, and an excellent track record of financial performance. New products are presented for applications such as sample preparation, analysis, and data interpretation.
This document provides an overview of Anteo Diagnostics and their nanotechnology applications. Anteo has developed a patented nanoglue technology called Mix&Go that can bind biological molecules to synthetic surfaces. They are applying this technology in four business areas: 1) in vitro diagnostics and life sciences markets, 2) bioseparations, 3) medical devices, and 4) batteries. For each area, Anteo's nanoglue can improve functionality, sensitivity, and cost efficiency. The document outlines Anteo's revenue generation process, partnership achievements, and the vast potential of their drop-in nanotechnology.
The Life Science Product Manager's Toolkitprothenberg
A discussion about market research tools that can optimize each stage of the new product development process. Prepared by BioInformatics LLC exclusively for life science product and marketing managers.
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...MilliporeSigma
Are you ready to accelerate biosafety testing?
The pressure to shorten delivery times and reduce costs for biologics such as mAbs are driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. These traditional testing methods are often culture based and can take several weeks to produce the required result to allow for batch release. In this talk we will explore how new methods can be used to accelerate biosafety testing today, as well as how they can evolve to meet new manufacturing paradigms such as continuous processing and novel cell and gene therapy treatment modalities.
Participate in the interactive webinar now: http://bit.ly/BlazarWebinar
Explore our webinar library: www.emdmillipore.com/webinars
Autologous and Allogeneic Cell Therapy Industrialisation – Overcoming Clinical Manufacturing Hurdles Early
A presentation by Chief Operating Officer, Dr Stephen Ward
1) Anteo Diagnostics will partner with Atomo Diagnostics to develop a rapid blood test for early detection of heart attacks using Anteo's coating technology and Atomo's AtomoRapid platform.
2) Atomo received $100,000 in funding from the Advance Queensland Johnson & Johnson Innovation QuickFire Challenge to create a proof of concept for their rapid heart attack test.
3) If the proof of concept is successful, Atomo and Anteo will consider fully commercializing an AtomoRapid-based cardiac troponin test, which could improve on current tests in the large and growing $350 million point-of-care cardiac biomarkers market.
Memsift news focus article for membrane technolgy oct 2020 (1) (1)Antony Prince
Memsift Innovations has entered into an agreement with the Connecticut Center for Applied Separations Technologies (CCAST) at the University of Connecticut. This agreement will enable Memsift to explore application studies and pilot trials for its brine treatment and zero liquid discharge technologies in North America. The CEO of Memsift sees this agreement as an important steppingstone to enter the North American market by bringing its cutting-edge technologies to potential customers through CCAST's testing facilities.
This document summarizes a presentation given by Dr. Robert Boorstein on drivers of change in the laboratory market. Five key trends are discussed: laboratory consolidation, growth of central laboratories vs point-of-care testing, new delivery models, new technologies, and increased competition across sectors. Laboratory consolidation is driven by cost reductions and allows for standardization but may shift market power from sellers to buyers. Point-of-care testing is growing rapidly but poses challenges to quality control. New national laboratory companies are emerging focused on unique branded products.
Dr. Adrian Stevens received his Ph.D. in computational chemistry from the University of Portsmouth. He has since worked for 9 years at a contract research organization specializing in small molecule discovery research and collaborated with pharmaceutical companies. Following a brief time at another company, he joined Accelrys in 2008 and is now a Senior Product Marketing Manager responsible for the Discovery Studio product.
QIAGEN exceeded its goal of placing over 750 of its QIAsymphony modular laboratory automation systems in 2012, up from over 550 in 2011. The company expects placements to exceed 1,000 by the end of 2013. Approximately 70% of placements so far have been with molecular diagnostics customers. QIAsymphony offers integrated sample processing and real-time PCR and gives customers access to commercial assays while allowing custom tests.
Medvantage International has acquired rights to a new vascular coupling device called CUVASLAR that represents an alternative to manual suturing for connecting arteries and veins. The device is expected to reduce surgical time, minimize errors from suturing, and improve patient outcomes. Medvantage plans to submit the device for FDA approval over the next year and market it to the 340,000 microsurgery procedures performed annually in the US.
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
Major developments in point-of-care (POC) testing were highlighted at the 2015 American Association of Clinical Chemistry Annual Meeting:
1) Several companies announced new POC devices, including a low-cost, battery-powered molecular diagnostics platform from Cepheid and a smartphone-based chlamydia test.
2) Existing POC tests for influenza, diabetes, kidney disease, liver disease, and pregnancy from companies like Alere, DiaSys Diagnostics, and Abbott were demonstrated.
3) The large POC diagnostics market, estimated at $17 billion globally, was a focus for many exhibitors given the potential for rapid results at the point of care.
Auto-injectors: choosing the right path | Insight, issue 2Team Consulting Ltd
The auto-injector market is growing rapidly due to a shift towards self-administration of therapies and a need for product differentiation. Auto-injectors provide patients independence and convenience over traditional syringe administration. While auto-injectors offer benefits, pharmaceutical companies face a complex selection process in choosing a development path for their product. Key decisions include whether to develop a new device, use an off-the-shelf option, or license a technology. Proper upfront planning is important to define needs and requirements, assess development options and timelines, and ensure regulatory approval.
Welcome to the M Lab™ Collaboration Centers – where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlab
Welcome to the M Lab™ Collaboration Centers – where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlab
The document summarizes key happenings and trends from the 2014 AACC annual meeting and clinical lab expo in Chicago. Specifically:
- Point of care and infectious disease testing were highlighted areas with over 20% of exhibitors.
- Emerging "grassroots molecular" point of care systems were showcased, including systems from Cepheid, Quidel, Nanosphere, and others aiming to provide sample to result testing outside central labs.
- Animal diagnostics and emerging metabolomics offerings were other notable areas exhibited by some companies seeking new opportunities beyond traditional human diagnostics.
This document provides information about the "CNS Clinical Trials" conference taking place on September 16-17, 2010 in London. The conference will examine strategies for successful CNS drug development and overcoming challenges in clinical trial design, management, and recruitment. Key topics will include novel cognitive assessment methods, advances in neuroimaging, adaptive trial design, and the use of biomarkers to demonstrate early drug effects in CNS trials. Speakers will include representatives from pharmaceutical and biotechnology companies as well as academic institutions. Attendees will gain insights on improving various aspects of CNS clinical trials from development through regulatory approval. The conference also provides sponsorship and exhibition opportunities for companies to promote their products and services.
March 5, 2015 PoCDx Seminar - Wallace White, Stratos - Development of the Pan...BerkeleyPoCDx
The document discusses the development of the PanDx integrated diagnostic platform by UC Berkeley. It provides an overview of the project, which aims to create a portable diagnostic device that can quickly diagnose diseases like HIV, TB, and malaria using different sample types in resource-limited settings. The device is being designed to be affordable, reliable, and able to function in areas with limited electricity. Updates are provided on the development progress, including demonstration cartridges being tested for tuberculosis, HIV p24 antigen, and ALT clinical chemistry assays. The goal is to have fully functional breadboard prototypes and performance data from hundreds of demonstration cartridge tests in multiple assays by the end of the current development phase in September 2015.
Farm is an ISO 13485-certified and FDA-compliant product development consultancy with over 40 years of experience helping medical, life sciences, and consumer healthcare companies. It offers expertise in areas like user research, engineering, design, and regulatory compliance. Farm helps clients design devices that are safe, easy to use and effective by employing research, usability testing, and a process-driven development approach.
Future Diagnostics, In Vitro Diagnostiek "Bloedserieus"Health Valley
Future Diagnostics strives to become a leading developer of innovative diagnostic tests. It aims to be the preferred partner of top IVD companies for outsourced test development. The company was founded in 1997 and now has 60 employees working on 34 projects. It has two facilities and is certified under ISO and FDA quality standards. Future Diagnostics has experience developing assays for various analytes on automated platforms and is interested in point-of-care tests and new testing technologies.
Innovative Solutions to Advance Immune-Mediated Inflammatory Disease Drug Dev...Covance
Recent scientific advances have propelled our understanding of the immune system's regulation, as well as identified targets that play key roles in inflammatory and autoimmune diseases. Immune-Mediated Inflammatory Diseases (IMIDs) share common pathways, creating the opportunity to treat multiple inflammatory diseases and improve treatment for millions of people worldwide.
Optimizing the Output of Your Molecular Pathology LaboratoryJosh Forsythe
If you are a clinical lab looking to build or accelerate your NGS testing capability where do you start? The components of success can be overwhelming - planning, assay design, validation, clinical lab workflow, informatics, and interpretation.
During this one-hour webinar, BG Jones, SVP of Business Development for PierianDx, who has 23 years of experience in healthcare IT and genomics technology, will demonstrate how to pull it all together using "Actionable Intelligence" - a combination of machine learning and human expertise to achieve clinically actionable insights.
#InvitroStudies are critical to the #drug and #wellness product #development due to their ability to provide a basis for #clinical in vivo studies for predicting best delivery model to take Go/No-Go decision. #Our solution on in vitro analyses can provide proof of concept on delivery dosage form in the early stages or reverse pharmacology #development of the active process, when the selectively and possible interactions of the active process, when the selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established. Our team can provide solution map on case to case basis for your specific requirement . For more details please visit on https://www.stabicon.com/In-Vitro.php
“The Most Recommended Pharma & Life Sciences Solution providers in 2021” highlighting the pharmaceutical and healthcare industries help to improving the human health and forwarding life-expectancy one step further.
DIR Technologies | DIR looks to bring 100% real time infrared inspection to t...DIR Technologies
DIR Technologies has developed an infrared thermal imaging system called the Induction Integrity Verification System (I2VS) that allows for 100% real-time inspection of induction heat seals on pharmaceutical packaging. The technology scans bottle caps and detects defects in seals, providing pass/fail results for every unit. Major pharmaceutical firms are adopting the system to replace manual sampling methods. DIR is now launching a new I2VS Lite model to expand into food and consumer goods markets. The system promises to increase quality assurance and reduce costs from defects.
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 summarizes discussions from a conference on continuous biomanufacturing. Key presentations discussed Amgen's goal of 5 g/L productivity using intensified processes, and the FDA's support for continuous manufacturing. Conference participants also discussed different continuous approaches like steady-state perfusion and dynamic perfusion. Integrating upstream and downstream processes continuously is an area still needing investigation. The best approach depends on a company's existing infrastructure and product portfolio.
1. IN PERSON
IVD Technology: What have been the
biggest technological advances in
assay development during the past
few years?
Fabrice Sultan: Assay development
continues to challenge the IVD indus-
try, which must bring accurate, reliable,
robust, and cost-effective assays from
the conceptual phase to the end-user.
The use of magnetic microspheres
and polymer beads as the solid phase in
automated immunoassays—resulting in
automation, faster reactions, increased
sensitivity, and shorter time per assay—
has been one of the biggest technologi-
cal advances. The technical capability
to develop and produce, on an industri-
al scale, one bead or one microsphere
for one application could explain, at
least in part, the increasing demand in
the field of microsphere technology.
For instance, our production capabil-
ities allow us to produce batches larger
than 6 kg for some of our magnetic mi-
crospheres used in immunoassays, and
up to 12 kg for polymer beads used in
immunoturbidimetric assays or latex
agglutination on slides. To produce ef-
ficient and reproducible immobilization
of immunoglobulin or other ligands,
such as proteins, lipids, or polysaccha-
rides, we offer the choice of working on
many different surfaces—hydrophobic
or hydrophilic, carboxyl-modified,
amino-modified, or thiol-modified.
Different surface chemistries, of course,
should be considered and evaluated in
preliminary screening protocols. How-
ever, the solid phase is, without a doubt,
a critical and important part of the assay.
How have magnetic microspheres and
polymer beads contributed to the area
of assay development?
With ELISAs (enzyme-linked im-
munosorbent assays) or with coated
tubes, you can work in two dimensions.
The main advantage of using magnetic
or polymer microspheres is that they
allow you to work in three dimensions,
dramatically increasing the surface and
sensitivity, and the high reaction kinetics
of your assay.
The evolution of assay development
To keep pace with advances in detection technologies,
assay manufacturers must remain resourceful.
Over the last decade, automation and other technological break-
throughs have revolutionized the clinical diagnostics laboratory.
Driven by a demand for both higher throughput and reproducibility, as
well as for lower costs per test and smaller sample size requirements,
instrument manufacturers have made significant progress in alleviat-
ing many former testing bottlenecks.
While these advances have ultimately benefited patient care, they
have also created challenges for assay manufacturers. To take advan-
tage of increased laboratory capability and instrument sensitivity, as
well as refinements to traditional testing methods, new assays must
also continually evolve. In addition, IVD manufacturers need to forge
strong relationships with customers and researchers to be able to an-
ticipate the next trends in assay development,
To learn more about how technology changes are affecting assay
manufacturers, IVD Technology editor Richard Park spoke with Fab-
rice Sultan, PhD, international marketing and sales manager at Estapor
Microspheres, a division of Merck Chimie SAS (Fontenay Sous Bois,
France). In this interview, Sultan discusses the impact of miniatur-
ization, multiplexing, and molecular diagnostics on assays. He also
talks about the state of the European testing market, and how manu-
facturers can—and must—build better research relationships with
academia.
Fabrice Sultan, PhD, is international
marketing and sales manager at
Estapor Microspheres, a division of
Merck Chimie SAS (Fontenay Sous
Bois, France). He can be reached at
fabrice.sultan@merck.fr.
For In Vitro Diagnostics Development & Manufacturing
R
2. Magnetic beads are probably the most
powerful tools for IVD manufacturers
looking to automate their immunoassays
because many types of proteins and lig-
ands can be easily attached to their sur-
faces. And the surface for the reaction
mixture is much higher than with clas-
sical ELISA plates or coated tubes.
What factors must IVD manufactur-
ers consider when developing assays
for their instrument systems?
When developing immunoassays,
IVD manufacturers must consider not
only the accuracy and reproducibility of
a new immunoassay reagent, but also its
stability and ease of adaptation.
We must consider two types of stabil-
ity. The classical stability of the reagent
in the cartridge should be around 12–18
months. And once the cartridge is
opened, the reagent stability should be
at least one or two months.
You can validate a product if you ob-
tain the same reproducibility results.
However, some immunoassay reagents
have a very short stability once the car-
tridge is opened. If a reagent has a shelf
life of 20 or 24 months when the cartridge
is closed, but only two weeks once it is
opened, it can be very difficult to sell.
What other assay development trends
do you see?
The latest trends are geared toward
achieving classical, common goals: sen-
sitivity and signal-to-noise ratio. Both
must be higher than they are now.
Specificity of an immunoassay must
be better. The dynamic range must be
increased, especially if you want to de-
tect a very low concentration of analyte.
Any assay technology that enables the
end-user to eliminate, or at least reduce,
the number of false-positive results is
always extremely advantageous. Also,
the cost of the assay must be lower, to
answer the economic pressures on both
IVD companies and clinical labs, and
also on patients.
From several studies, we know that
labor accounts for 50–70% of the total
cost of tests. The most logical way to re-
duce this cost is the automation of com-
mon bioassays and immunoassays. Of
course, new automated tests can also
show better results than semiautomated
or manual ones.
How can IVD manufacturers address
these challenges?
A complete market survey is essential
before IVD manufacturers begin de-
signing and developing a new assay
product. Of course, a company’s strate-
gy will be different for a me-too product
than for a truly innovative one. For the
first, cost and services are the keys to
success. For the second, manufacturers
need to answer the following questions:
What is the clinical utility of this new
assay? What is the test volume? What
are the sales by geographic region and
the total profits? What market share do
I want to reach? What could be the pos-
sible alternative with a new technology
in the near future?
IVD companies must be faster than
ever and provide a broad menu of diag-
nostic tests. Time to market should be re-
duced to a minimum. It’s very easy now
for some big IVD companies to exter-
nalize part of their R&D to launch new
assays in a shorter period. But the chal-
lenge will be to keep the production
internal.
I can see two main options. IVD com-
panies can employ their own staff and
capabilities, or they can accomplish this
through codevelopment with other com-
panies or with universities. Any type of
collaboration must be a win-win agree-
ment. For example, large companies can
offer name recognition and a worldwide
sales force or distribution network,
which are both key advantages for small
IVD companies. And small IVD com-
panies can offer increased flexibility,
more freedom, and access to intellectu-
al property.
There have been a number of these
types of collaborations. For example,
Roche Diagnostics (Basel, Switzerland)
and Prionics AG (Schlieren, Switzer-
land) have worked together on a test for
bovine spongiform encephalopathy.
Beckman Coulter Inc. (Fullerton, CA)
and R&D Systems (Minneapolis) have
signed an agreement for developing as-
says and assay components for Beck-
man Coulter’s Access immunoassay
systems.
To secure sources of critical raw ma-
terial—both in quality and quantity—
IVD manufacturers should evaluate and
validate two possible suppliers: one
main supplier, and a secondary supplier
for the solid phase, the antibodies, or the
antigen. Of course, for some companies,
secondary antibodies and substrate sup-
plies must be secure, too.
We know that the cost to validate each
critical raw material is very high. But
this is critical for IVD manufacturers.
For security reasons, many IVD compa-
nies now produce their own antibodies
or antigens. And some of them have
their own solid-phase production. Of
course, doing so is much more secure,
but at what cost?
Do you expect IVD manufacturers
to continue forming these types of
collaborations?
Oh, yes. I can add to my examples
others like the ongoing partnership be-
tween Abbott (Abbott Park, IL) and
Axis-Shield Plc (Dundee, UK), as well
as the collaboration between Dade
Behring Inc. (Deerfield, IL) and The
Binding Site Ltd. (Birmingham, UK).
Merck partners with academics in
order to develop new magnetic particles
and polymer beads. We are always work-
ing with our customers to optimize our
products with their immunoassay
reagents.
Partnering with Academia
How important is it for IVD and di-
agnostics component manufacturers
to form relationships with academic
researchers to develop assays?
It’s fundamental to have an excellent
network between IVD manufacturers,
academic researchers, and hospital or
blood bank centers. From our viewpoint,
the majority of IVD manufacturers have
been working with academic researchers
in developing assays. Many new bio-
markers, like NT-proBNP, which has a
clinical utility for acute coronary syn-
drome, have been discovered by acade-
mic researchers. And after this research
has been conducted, diagnostics compa-
IN PERSON
3. nies have the opportunity to add new im-
munoassay reagents to their test menu.
One possibility for IVD manufactur-
ers is to establish, or even share, scien-
tific laboratories. For example, in France
there are a number of Unités Mixtes de
Recherches, or joint research units,
which are very efficient scientific col-
lectives between IVD companies like
bioMérieux or Bio-Rad France and
well-known scientific institutes like the
CNRS (French Center for Scientific
Research). Such collaborations can
increase the possibility of finding
new biomarkers or developing new
immunoassays.
How do IVD manufacturers go about
developing and nurturing these rela-
tionships with academia?
There are a few different ways. A
company can sign financial agreements
with academic researchers—to develop
a new immunoassay on a new biomark-
er, for example. Companies can also as-
sist researchers with grants or fellow-
ships. And again, I think having IVD
staff share the scientific laboratory with
scientific researchers is very important.
These scientists spend two to four
years in our lab working directly with
our R&D department. This is a very
common arrangement in France. We
share the results of the research with the
university.
It is the case in France, as I’m sure it
is in the rest of the world, that researchers
lack money. As a result, they need to find
new ways to obtain financing to contin-
ue their scientific work.
The sense that I get when speaking
with academic scientists is that they
are always seeking out industry
partnerships to commercialize their
projects.
Yes. I think that the development of a
new immunoassay can be viewed as a
two-step process. The first step involves
academics in the discovery of new bio-
markers with clinical utility. And after
some years—because it’s a long
process—it might be possible for a
company to use the results of this re-
search to develop its own immunoassay
reagent.
Adopting Molecular
Diagnostics
How have developments in molecular
diagnostics and pharmacogenomics
affected assay development?
In my opinion, diagnostics develop-
ments using the polymerase chain reac-
tion (PCR) and related methods will
have an impact primarily in the field of
infectious diseases. Immunoassays for
detecting HIV or a specific antigen can
easily be created by using classical
methods.
More and more molecular diagnostic
reagents have come onto the market in
recent years. Instead of detecting an an-
tibody or antigen, these types of tests
bind the nucleic acids from the cells and
amplify them through PCR or a similar
method. The infectious disease is then
detected and computed using the con-
tent of nucleic acid.
But for cardiac markers, en-
docrinology, drugs of abuse, or fertili-
ty tests, molec-ular diagnostics is not
having much of an effect on assay de-
velopment. These are sophisticated
methods. Of course, they are already
being used by many hospitals. But I
cannot think of any IVD manufacturers
that are poised to offer a large menu of
assays that use this kind of technical
approach.
In March of last year, some of the
foundational PCR patents, which are
owned by Roche Diagnostics, began
to expire. As additional Roche PCR
patents enter the public domain, do
you think more IVD companies will
embrace molecular diagnostics?
Probably, yes, because one limit so
far to developing such assays has been
cost. If you have to pay for the develop-
ment and the production, and the mar-
keting and the sales of such reagents—
and then you also have to pay for the
patent—in the end, profits will be very
low. And if the profit is low, many com-
panies might not consider the assays to
be wise investments.
But with the disappearance of fees for
PCR use, we probably will see more and
more molecular diagnostic reagents and
instruments coming onto the market in
the next few years.
How about further into the future?
Do you think that these technologies
will have more of an impact as they
mature? Say, in 10 years from now?
In the next decade, we will likely see
many IVD manufacturers working with
multiplexing assays, quantitative lateral-
flow assays, biochips, biosensors, and mi-
crofluidics. We will also see important
developments in the point-of-care field.
The Next Generation of IVDs
What future assay development chal-
lenges do you anticipate facing?
Miniaturization of immunoassays is
a major goal in medical diagnostics,
but also in food and environmental
analysis. There is an important need for
multiplex analyses with three main char-
acteristics: a high degree of automation,
fast analysis, and a small volume of
sample reagents.
Will IVD manufacturers in the assay
market become more involved with
nanotechnology and microarrays?
Yes, I think so. There’s been a lot of
cooperation in these areas between big
IVD companies working on classical
immunoassay instruments and some
new players in this field. In nanotech-
nology, there have been collaborations
regarding biochips and biosensors, as
well as microfluidics.
The business managers at large diag-
nostics companies have to keep an eye
on these new technologies because they
may prove to be a very efficient way to
reduce the costs of analysis. For exam-
ple, instead of using 10 or 20 ml of blood
to detect the HIV or hepatitis virus, in
the next few years, we may need only
a few microliters. And if the sample is a
few microliters, we will also need only
a few microliters of reagent.
What trends can we expect to see with
the use of magnetic microspheres and
polymer beads in assay development?
We are continuing to develop both
magnetic and polymer beads with new
surfaces in order to allow developers to
optimize and obtain the best reagents. But
we are also working on new types of
beads,suchasthoseusingmolecularprint.
With molecular printing, instead of using
an antibody or an antigen cut onto the