Author Archives: BPI Contributor

Validated Quantitation and Activity Assay of Antibody Fragment Molecule (Fab) for Process Development and Quality Control

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The analytical group at Boehringer Ingelheim, Fremont, USA needed a robust assay to measure the biological activity of an antibody fragment (Fab) molecule for in-process testing as well as stability and lot release testing in their Quality Control (QC) department. The developed Fab activity assay is accurate and robust, with intermediate and intramediate precision less than 10%. Drug activity measurement using the Octet® system has become a critical parameter for their product evaluation and has resulted in increased Fab drug…

February 2, 2022

Improving Plasmid Design, Process and Manufacturing to Improve Viral Vector Yield

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This webcast features: Richard Parker-Manuel, Group Leader for Plasmid Engineering and Production at OXGENE, WuXi Advanced Therapies. Successful development of cell and gene therapies requires robust, scalable manufacturing processes which generate high-quality material. There are substantial challenges associated with producing high viral yields and with navigating the regulatory environment to bring a therapeutic to market, a process which is often expensive and inefficient. Many challenges are attributable to the plasmid design and manufacturing step, where plasmids are the building blocks…

January 28, 2022

Accelerate Biologic Process Development and GMP Manufacturing Using In-Line Concentration Measurement

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This webcast features: Ramsey Shanbaky, Associate Director, Bioprocess Applications, Repligen In-process measurement is the key to process monitoring and control. It can save time and money by helping you identify key aspects of your process in real-time. In this webcast, we will demonstrate how the CTech™ FlowVPX™ Slope Spectroscopy System, when directly integrated in one or more locations of a process stream, has helped reveal process characteristics that until now have been hidden due to the limitations of the most…

January 27, 2022

Security of Supply Risk Mitigation in HCP Monitoring

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The most common method scientists use to monitor host cell protein (HCP) levels in biologics is the enzyme-linked immunosorbent assay (ELISA). For the reagent, security of supply is a regulatory requirement â â€” it’s a factor that’s critical to consistently monitoring HCP during biologic production. In this webinar, we discuss why security of supply is important, the consequences of not having it, and how to mitigate this risk. Topics covered Why security of supply is critical to your HCP plans Consequences…

January 18, 2022

The Production and Application of Antibody Fragments

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Antibodies are modular defense systems that identify and neutralize foreign objects like bacteria and viruses. In addition to oncology and inflammation, antibodies are now recognized as routine molecules in many therapeutic fields. Antibody fragments, in particular the Fabs, scFvs and VHH retain full antigen-binding capacity and superior properties for research, diagnostic and therapeutic applications. They have a smaller size that enables their binding to hidden epitopes not accessible to whole antibodies. In the context of therapeutic applications, a small molecular…

January 12, 2022

BioProcess Insider State of the Industry — December 2021 Panel Discussion

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This webcast features: Georgia Sloboda, Managing Director, Latham BioPharm Group; John Hamer, Head of Sales & Marketing, Aseptic Filling Workcells, Cytiva; and James Taylor, PhD, Co-Founder & General Manager, Precision Nano Systems Inc. BioProcess Insider’s State of the Industry takes a deeper look into the recent business news affecting the biomanufacturing industry, picking apart the numbers and highlighting potential trends. With a panel of industry experts, editor Dan Stanton will discuss recent M&A in the bioprocess space, bottlenecks within the…

December 17, 2021

Development of an Automated AAV8 Capsid Titer Assay on Gyrolab® xPand Immunoassay Platform

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This webcast features: Matthew Lotti, Senior Research Associate, Ultragenyx. The fast-growing gene therapy industry is in pressing need for fast and reliable analytical methods to accelerate bioprocess development and manufacturing of AAV viral vectors. Matt Lotti, Senior Research Associate II at Ultragenyx, a pharmaceutical company developing therapies for patients with rare genetic diseases, will present how the Analytical Development team at Ultragenyx developed a Gyrolab-based assay that demonstrates acceptable accuracy and precision for supporting in-process testing of AAV8 capsid titer.…

December 10, 2021

Protecting Protein Stability with a Novel Grade of Sucrose

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Ensuring the chemical and physical stability of the therapeutic protein is critical to the safety and efficacy of biopharmaceuticals and presents one of the major challenges in formulation. A number of excipients, including sugars, can be used to solve this problem. Sugars are stabilizers that maintain conformational stability by preferential exclusion and function as cryo- and lyoprotectors in lyophilized formulations. Given these properties, it is not surprising that sucrose is one of the most widely used stabilizers in marketed drug…

December 9, 2021

Modernize Your Gene Therapy Analytics with Automated Tools from Bio-Techne

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This webcast features: Chris Heger, PhD, Director of Applications Science, Bio-Techne. Modern medicines call for modern technologies. Gene therapy is an exciting approach at work to cure diseases, where genetic material is delivered to a patient via a viral vector. This approach requires a doubly complex drug that contains both protein and oligonucleotides, and existing analytical tools just don’t meet the quantitative needs of these complicated therapeutic agents. In this webinar, hear how a variety of innovative analytical tools from…

December 8, 2021

Human Umbilical Cord-derived Mesenchymal Stem Cell Production in Corning® HYPERStack® 36-layer Cell Culture Vessels

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As more clinical trials are evaluating MSC-based therapies, the demand for more pertinent adherent scale-up tools is likely to increase. Corning® HYPERStack® 36-layer cell culture vessels offer a closed system solution for scaling up large quantities of quality, human umbilical cord-derived MSCs. Most importantly, the MSCs expanded in the HYPERStack 36-layer vessel expressed high percentages of CD90, CD105, and CD73, characteristic of MSC quality. The ability to grow large quantities of human umbilical cord derived MSCs with high viability and…

December 8, 2021