Ask the Experts

Increasing Productivity of IVT Reaction Using At-Line Monitoring by HPLC Chromatography

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This webcast features: Rok Sekirnik, PhD, Head of Process Development mRNA/pDNA, BIA Separations, now a Sartorius company. In Vitro Transcription (IVT) reactions are normally performed as batch processes. Considering their catalytic basis, it is possible to extend reaction times and yields by continuous addition of consumed reagents to the reaction mixture. However, fed-batch strategies reported to date have only managed to achieve a 40 – 100% increase in the production of mRNA. One of the main limitations of development has…

March 7, 2022

Improve Your Cell Line Development Workflows with Analytical Tools

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This webcast features: Dirk Müller, PhD, Manager of Media & Process Development, Sartorius, Lukas Klein, Scientist, Sartorius. Cell line development involves screening thousands of clones to find those that are stable, produce high yields of the bioproduct, and exhibit desired critical quality attributes (CQAs). While there are multiple CQAs that need to be monitored early in the development process, product yield, cell count and viability assessment remain the main attributes by which process conditions are optimized. Incorporating analytical techniques into…

March 2, 2022

Viral Clearance: A WuXi Advanced Therapies Perspective

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This webcast features: Kathleen Kenney, Associate Director, Viral Clearance, WuXi Advanced Therapies, R. Christopher Manzari, Manager, Viral Clearance – DSP/Virus Production, WuXi Advanced Therapies. Join us for a discussion on the risk-based approach in the development of Viral Validation studies, a key testing requirement for regulatory submissions of viral vector-based therapeutics, at WuXi Advanced Therapies. In this webinar, members of the Viral Clearance Management team will cover the basics of viral clearance, study development and the general timeline. Collaboration between…

February 24, 2022

Promoter Discovery for Optimized Viral Vector Development

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This webcast features: David W. Brighty, PhD, Head of Bioprocessing Research at OXGENE, WuXi Advanced Therapies. A primary determinant of gene expression is invariably the activity of the promoter upstream of the regulated gene. Viral vectors used to deliver a therapeutic transgene into target cells to treat disease are no exception. For viral vectors, the promoters used to drive transgene expression are typically constitutively active, often display little tissue-specificity, and frequently fail to express the therapeutic transgene at optimum physiological…

February 18, 2022

Addressing Purification Challenges for Complex Therapeutics with Custom Chromatography Resins

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This webcast features: Laurens Sierkstra, Business Segment Leader, Bioproduction Group, Thermo Fisher Scientific. Ongoing progress in biotherapeutics development has initiated an increasing range of complex molecules entering the drug development pipeline such as novel vaccines and therapeutic proteins. This often rises challenges in the manufacturing process of these newer modalities, with downstream operations as a focus point as this part of the production process frequently represents a bottleneck. Addressing downstream challenges requires novel purification strategies for commercial manufacturing which may…

February 16, 2022

Ask the Expert: A Scalable Platform for Production of High-Quality and GMP-Grade Plasmid DNA

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Demand continues to grow for clinical- and good manufacturing practice (GMP)-grade plasmid DNA (pDNA) amid the proliferation of therapies based on mRNA and viral vectors. At a newly acquired manufacturing facility in San Diego, CA, Wacker Chemie is expanding its capabilities with a scalable platform for pDNA production. In October 2021, Mack Kuo (associate director of bioprocess development at Wacker Biotech US) showcased the site’s capabilities and described how it can provide comprehensive, customizable services for plasmid production. Kuo’s Presentation…

February 4, 2022

Ask the Expert: Bolstering Manufacturing Capacity and Achieving Supply-Chain Resilience

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The novel coronavirus pandemic has exposed vulnerabilities in biopharmaceutical industry approaches to supply-chain management. Drug developers and manufacturers have tended to presume suppliers’ access to raw materials for bioprocess components. However, global crises disrupt reliable access. Ari Ojinaka (production manager at Astrea Bioseparations) joined BPI in October 2021 to explore strategies for navigating supply-chain uncertainty. He described how his company seeks to optimize manufacturing capacity, enhance communication with its suppliers and customers, and support a quality-driven company culture. Ojinaka’s Presentation…

February 4, 2022

Ask the Expert: Scale-Up Success for Cell Cultures in Single-Use Benchtop Bioreactors

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During process development (PD), single-use (SU) bioreactors can streamline cell-culture workflows and reduce risks for contamination and operator errors. But transferring cultures from laboratory- to benchtop- and pilot-scale vessels requires consideration of fundamental bioreactor principles. In October 2021, Ann D’Ambruoso (manager of product applications and marketing) and Cristina Bernal Martinez (applications support engineer, both at Getinge) reviewed factors for scale-up success and presented a case study involving transfer of cell cultures to Applikon AppliFlex SU stirred-tank (ST) reactors. The Presentations…

February 4, 2022

Ask the Expert: Optimized Cell Line Development for CHO DG44 Expression Systems

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In November 2021, Rathangadhara Nammalwar (manager of protein-based therapeutics at Sartorius) delivered a presentation describing the hallmarks of a robust cell line development (CLD) platform. Focusing on the importance of expression constructs, he then explained how collaboration with external partners has enabled Sartorius to optimize its Cellca CLD platform for mammalian-cell production of therapeutic proteins. Nammalwar’s Presentation Nammalwar identified key criteria for selecting a CLD platform, noting first that it should leverage a highly productive cell line that yields high-quality…

February 4, 2022

Ask the Expert: A Platform for Purification and In-Process Analysis of Adenovirus Vectors

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Despite safety-related setbacks in the early 2000s, adenovirus (Ad) again is gaining traction as a vector for advanced therapies and vaccines. Thus, Ad production is accelerating. In November 2021, Hana Jug (project manager in process development for viral vectors and vaccines at BIA Separations, a Sartorius company) described how her company’s updated platform process for Ad vectors could enhance their purification, maximizing recovery of critical vaccine components. Jug also highlighted BIA’s abilities to supply chromatographic columns consistently and to support…

February 4, 2022