Scale-out Manufacturing – A Critical Risk Mitigation Strategy for Biologics Production

Speed-to-market, flexibility and process efficiency are more important than ever in biopharmaceutical production. And so is the importance of single-use systems. Single Use Support enables innovative process solutions around aseptic fluid management and improves aseptic liquid transfer in various manufacturing facilities. And yet there is hesitation.Dr. Lorenzo De Benedictis provides insights and outlook on the future of single-use systems in Biopharma.

In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.

In this podcast, Richard Mirro, business manager at the Bioprocess Center of Eppendorf AG, explores how smart bioprocessing can help labs adapt to today’s demands, driving efficiency while making the development and production of next-generation molecules not only more economical, but also more reliable.

Metabolic Flux Analysis (MFA) is a powerful technique used to characterize metabolic phenotype driving to improved productivity in biomanufacturing. MFA is most powerful when absolute concentrations of the metabolic intermediates are measured, but doing so in practice is often impractical due to inherent limitations of conventional absolute quantitation by mass spectral analysis. Recently, advances in artificial intelligence (AI) have been applied to solving the problem of broad, untargeted, absolute quantitation in liquid chromatography-mass spectrometry (LC-MS). These new approaches extend readily to the determination of absolute concentrations of stable isotopically-labeled metabolic intermediates, offering a new tool for MFA. Dr Sam Yenne from Metalytics Inc., a company that specializes in the science of metabolic flux, has recently assessed and adopted Pyxis, a new tool for absolute quantitation of raw LC-MS data. Dr Yenne describes MFA, its utility in biopharmaceutical development, associated challenges and how Pyxis impacts those challenges.

After being diagnosed with Hodgkins lymphoma at age 15, Dr Joshua Schiffman was driven to pursue a career in medicine, starting as a pediatric oncologist, and was later drawn to the biotech side of the industry. Dr Schiffman was fascinated with a tidbit of knowledge: elephants almost never get cancer. He met Dr Avi Schroeder at a conference in Israel, and the two wondered how they could take this research about elephants’ cancer-fighting genes and apply it to humans. Together, they co-founded PEEL Therapeutics, the organization’s name meaning elephant in Hebrew, and currently work to bring together nature, medicine, and technology for the betterment of humankind. In this episode, Dr Schiffman provides a hopeful outlook on how nature and biotech can lead scientists to harness the power of evolution and create a bright future for medicine.

In this interview, we will talk about the advantages of changing from shake flasks to stirred-tank bioreactors, but also about the problems that can occur and things that have to be considered, in order to ensure proper cell growth.