Continuous Capture and Continuous Recovery – Novel Ideas for Product Recovery from Perfusion Process Using ATF

Alvotech developed an intensified fed-batch process using a cell retention device for the production of a complex fusion protein. The process uses the novel technique of High Productivity Harvest (HPH), which involves a traditional FB process and a clarification process using a cell retention device. Implementing the new process resulted in higher vcd and viability, improved product quality, and a reduction of cost of manufacture compared to the conventional fed-batch process.
Presented by Dr. Kerstin Lange, Team Lead Process Technology and Innovation, Advanced Bioprocessing At Alvotech

Kerstin obtained her Diploma and PhD degree in Biochemical Engineering from the TU Dortmund University in Germany. She joined Alvotech in 2017 and has been actively contributing to the development of new upstream processes. Today she is the team lead in the Process Technology and Innovation group, heading the Advanced Bioprocessing team. The team focuses on the investigation of innovative processes, process intensification, and process optimization.
And Andrew Falconbridge Vice President Process Technology and Innovation, Alvotech

Over 30 years in the Biotechnology industry. Over that time worked in the manufacturing and development of Vaccines, therapeutic/Diagnostic enzymes, and Mabs. Started career at  Welcomes then at Genzyme as before moving to Alvotech where has been for 5 years developing Biosimlers as Director of Drug substance development and Now Vice President  of Process Technology and Innovation, responsible for driving new technologies and innovation within Alvotech for development and manufacturing
 
Followed by Earl Pineda Sr. Manager, Upstream Field Applications EU/APAC at Repligen

Earl Pineda is currently managing the Repligen Field Applications Scientists team for Europe and Asia.  Earl has been in the biotech industry for 20 years, working at Refine Technologies and at Repligen Corporation, helping hundreds of companies successfully implement the XCell ATF® technology in Europe and Asia.  Earl previously worked at major biotech companies such as Amgen, Novartis, and Biomarin, performing different research functions in process development, MSAT, and technical transfer.  An expert in perfusion processes, Earl has experience with cell retention technologies, including XCell ATF®, KrosFlo® TFF, gravitational cell settlers, acoustic cell retention, centrifugation, and microcarrier-based systems.  At Biomarin, Earl helped develop several commercial perfusion processes for Aldurazyme and Naglazyme.  At Refine and Repligen, Earl helped develop the XCell ATF® Single-use System and designed user interfaces for several ATF controllers.

Inspiring advances in bioprocessing, Repligen is a technology leader in filtration, chromatography, systems, process analytics, and Protein A ligand development for bioprocessing and gene therapy. Propelled by a culture of innovation and collaboration, and with a focus on cost and process efficiencies, our people and our technologies help address critical steps in the production of therapeutics, vaccines, and diagnostics worldwide. Named one of the fastest growing biotech companies in the USA, Repligen is headquartered in Boston, MA with major manufacturing sites in Massachusetts, California, New Jersey, Sweden, and Germany.