Extractables from Single-Use Bioreactors/Bags and Impact on Cell Culture Performance
22nd January 2019 | 10.00 am EST | Yasser Nashed-Samuel, Principal Scientist at Amgen and Donald Young, Sr. Product Manager at Thermo Fisher Scientific |WATCH FOR FREE
Attribute Sciences, Process Development, Amgen Biopharmaceuticals are drugs manufactured by growing genetically engineered cells in bioreactors to produce a therapeutic protein. Plastic single-use bioreactors are of interest to biopharmaceutical drug manufacturers due to their significant environmental and cost benefits and flexibility over stainless steel bioreactors. Effect of plastics on the biomanufacturing process is not yet completely understood. A case study on extractables from single-use bioreactors/bags and impact on cell culture performance will be presented.
Presented by Yasser Nashed-Samuel, the Principal Scientist at Amgen
Yasser Nashed-Samuel is the Principal Scientist with fifteen years of biopharmaceutical experience and founder of the E&L and forensic function at Amgen. Currently, leading a central analytical group supporting cross-function activities (upstream, downstream and fill finish) related to analytical methods (development, qualification, validation, transfer), E&L, drug product development, device/primary containers development and qualification, single use systems (SUS), raw materials and forensic investigations throughout the Product Lifecycle. Recognized as a thought leader in product contact assessment, published 50+ journal articles and presented 25+ talks at conferences, presented strategy to the FDA and co-published paper with the FDA staff that influenced the E&L regulatory landscapes.
His specialities include Method development, E&L, Forensics (NC, CAPA, BPDR), Raw materials, Primary containers (PFS, vials, DS containers), Devices, Single-Use Systems, Glass delamination, Combination products, Process characterization, Manufacturing, Protein surface interactions to containers and trace analysis, CMC. To date his major accomplishments include:
- Founder of Amgen E&L program and developed successful E&L regulatory strategy.
- Scientific lead on drug/syringe/device with successful regulatory filings.
- • Started and led a new analytical functional team focusing on forensic investigation.
- Identified key leachables (from SUS, syringes, devices…) that impacted cell culture yield and/or patient safety.
- Led SUS/syringe/device manufacturers to redevelop their products.
- Presented lunch and learn seminar on E&L at the FDA (Sep. 2013)
Thermo Fisher Scientific supports developers and manufacturers of biological-based therapeutics and vaccines with a world class product portfolio that spans the bioprocessing workflow from discovery through large-scale commercial production. Starting with production-grade raw materials and supply chain logistics, we provide solutions and services across the manufacturing value stream and through QC release of finished goods, including upstream cell culture, downstream purification, analytical and QC testing, end-to-end single-use technologies, and comprehensive measurement and control solutions.
Followed by Donald Young, Sr. Product Manager at Thermo Fisher Scientific
Donald Young is the Product Manager for BioProcess Containers, at Thermo Fisher’s BioProduction Division facility in Logan, Utah. He has a Bachelor of Arts degree in Biology and a Master of Science degree in Public Health. Don has 10 years’ experience as a product manager. Don started his career as a laboratory technician specializing in cell culture and joined Thermo Fisher after working as a medical science liaison at Abbott Laboratories and Merck, Sharp and Dohme for 12 years. Don’s management of BioProcess Containers entails participation on cross-functional teams that manage change control, pricing, supply chain, film portfolio, training, product customization, and component library maintenance.