Posted by Julia Adam | Under Analytical development, Process development, Regulatory, webinar
Monday Mar 10, 2014
Posted by Julia Adam | Under Conference announcement, Quality, Quality by design, Vaccines
Monday Mar 10, 2014
To ensure the safety and efficacy of biopharmaceutical products administered to patients, manufacturers are expected to measure and control impurities in their products, including the host cell components and process additives that may leach into the process stream and final product. Tracking the clearance of these residuals is an essential part of process development and characterization. Since residuals are typically present at varying levels throughout the process, analytical method development and optimization can be challenging. In addition, detailed regulatory guidance on acceptable limits does not exist for all residuals.
In this 75-minute Biopharm International webinar sponsored by Eurofins Lancaster Laboratories, Dr. Sheila Magil, Senior Consultant, will provide an overview of manufacturing challenges presented by residuals in biopharmaceutical manufacturing, as well as regulatory expectations. We encourage you to register for this webinar to learn about challenges presented by residuals in biopharmaceutical manufacturing, regulatory expectations, analytical approaches for cell- and process-associated residuals, a platform method technology for residuals, and matrix effects. In the meantime, if you like to learn more about BPTC’s CMC analytical, quality, and/or regulatory consulting services, please email Julie Adam (jadambptccom) .
Posted by Julia Adam | Under Conference announcement, Outsourcing
Friday Mar 7, 2014
Dr. Keith Wells, Senior Consultant, will be presenting at the IABS International Scientific Workshop, “New Technologies, New Vaccines,” being held from March 23-26 in Wilmington, Delaware. This conference is the eighth in a series that began in 2006, and was previously titled “New Cells, New Vaccines”. Over the years the conference has followed the progress of new vaccines made using new cell substrates and new technologies from concept through clinical development to new products. Keith’s talk on “QbD in Process Development of Live Virus Vaccines” will be presented on the afternoon of Tuesday, March 25 and will focus on the application of quality by design (QbD) principles to the early stages of live virus vaccine development. To learn more about BPTC’s expertise in vaccine development, please contact Keith (kwellsbptccom) to pre-arrange a meeting at the conference.
Posted by Julia Adam | Under Raw materials, Supply chain
Thursday Mar 6, 2014
Once again BPTC will be venturing west to sunny San Diego to participate in IBC’s BDP Week where several BPTC consultants will be featured in key roles at the conference. Susan Dana Jones will chair a session on Developability Assessments and Candidate Molecule Selection in the Antibody Development and Production-Upstream track at 1:10 PM on Tuesday, March 25 during which speakers from Genentech, Jansen, and Bayer will discuss their latest data on antibody discovery, lead selection, and approaches to improve process control and product quality. If you’re looking for a CMO or have questions about technology transfer, be sure to attend the session on New Models for Increasing Efficiency in Outsourcing and Technology Transfer in the Contract Manufacturing & Technology Transfer track at 1:45 PM on Monday, March 24. In this session you will hear first-hand from Patti Seymour and Justin Skoble on how to effectively manage the CMO selection process and take full advantage of the knowledge and experience gained by a Sponsor during product development to ensure that technology transfer to a CMO goes smoothly. And, to wrap up your conference experience, plan on attending the Innovation and Efficiency in Process Development and Manufacturing track at 4:00 PM on Wednesday, March 26 where Howard Levine will host keynote presentations on creating value through innovation in biomanufacturing.
To learn more about how BPTC can assist you with all aspects of your product development and manufacturing needs or to schedule a meeting with one of us in San Diego, please contact Julie Adam. (jadambptccom)
Posted by Julia Adam | Under Conference announcement, Disruptive technologies, Manufacturing technology
Thursday Mar 6, 2014
Tom Ransohoff (transohoffbptccom) and Sheila G. Magil (smagilbptccom)
It’s a given that the quality of raw materials impacts the quality of biopharmaceuticals. When manufacturers change the processes to produce raw materials, release testing is conducted to confirm that the materials still meet specifications. However, these specifications are based on the supplier’s notion of the critical quality attributes. Identifying the critical quality attributes of a raw material requires an understanding of the relationship of the raw material and its impact on the quality of the drug being produced. However, early in development, biopharmaceutical companies cannot always identify critical attributes. Without this knowledge, the developer cannot evaluate the impact of raw material changes on product quality. Given the potential for unforeseen effects of raw material changes on a biopharma manufacturing process, how can the customer ensure that suppliers inform them when important changes in production or testing are made? Two-way communication is key.
Raw material suppliers understand their products and test to specification, but changes in their manufacturing processes, which they may not view as significant, may have a major impact on their customer’s product quality. For many customers the only communication of a raw material’s attributes may be the Certificate of Analysis shipped with their purchase. Can a customer reasonably expect notice of every change a raw material supplier intends to make before the chance is made? Can the suppliers afford to inform every customer about every change? One approach customers can implement is to develop quality agreements with material suppliers whose products have a high probability of impacting product quality. However, for small, early stage drug developers the solution may not be this straightforward as they may lack the knowledge and resources to address the issue. Yet, risk assessments and information networks may be two useful tools for early stage product companies to help identify the critical materials within their supply chain.
One recent example of an information network is the June 2011 symposium convened to discuss the problem of glass delamination. Present were representatives from the pharma and biopharma industry, glass manufacturers and representatives from the FDA and USP. In summarizing the results of the RX-360 Symposium, one of the key points identified was the need for improved communication and partnering between glass suppliers and pharmaceutical manufacturers. Specifically, customers and suppliers need to openly communicate on glass manufacturing processes, aspects of glass formulations, and aspects of (bio)pharmaceutical formulations.
Clearly, the customer cannot expect the raw material supplier to understand all their needs for a particular material. But neither should the supplier assume that the testing they provide is sufficient for all customers. Biopharma companies are relying on an ever-increasing range of suppliers for raw materials and disposable processing components. As the biopharma supply chain increases in complexity, so does the need for a true, information-sharing partnership between customers and suppliers.
Tom Ransohoff, Vice President and Senior Consultant, will lead a panel session at Interphex 2014 titled, “Thinking Outside the Column: New Approaches to Downstream Processing.” The panel will include experts from industry to review alternatives to traditional batch chromatography in addressing future needs for biopharmaceutical purification. To schedule a meeting with Tom at the conference, click here (transohoffbptccom) .