Author Archives: BPI Contributor

Autologous CAR T-Cell Manufacturing Using a Semi-Automatic, Closed, Modular Workflow

by

There have been tremendous efforts to make CAR T-cells more effective, safe, and persistent when treating patients. On the manufacturing side, however, errors, lot-to-lot variation, and contamination can be associated with open processes and manual handling of CAR T-cells. Cell isolation, gene editing, expansion, and cryopreservation are complex steps in a typical autologous CAR T-cell manufacturing process. Integrating this complicated multistep workflow into a closed, modular, benchtop system can facilitate transitions from laboratory scale to clinical manufacturing and improve the…

March 14, 2022

7 Key Questions for Understanding the Benefits of Scale-out Biomanufacturing

by

Changes in production scale required due to increasing product needs throughout clinical trials introduces risk to the product development timeline. Both the process and the product can be dramatically impacted from scaling-up to larger production volumes due to changes in the bioreactor microenvironment. By “scaling-out,” instead of “scaling-up” these risks can be mitigated. The “scale-out” biomanufacturing paradigm, which involves simply adding one or more of the same-sized bioreactor to the manufacturing run to obtain the production volume required, can also…

March 9, 2022

Material Transformation in Wet Granulation – The Effect of Continuous Process Dynamics, Material and Formulation Properties

by

Continuous manufacturing (CM) is increasingly used as an alternative to traditional batch manufacturing of solid pharmaceutical dosage forms. Wet granulation is one of the manufacturing technologies that was successfully migrated from batch to continuous processing. Thereby, the residence time of material under (stress) conditions is significantly reduced which in many cases is a main advantage of CM. However, in other cases with slow transformation processes this raises new challenges. In particular, the question arises as to which process parameters and…

March 8, 2022

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

by

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

by

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

3M™ Harvest RC Chromatographic Clarifier Beta Testing Series Summary

by

Frost & Sullivan invited a panel of industry leaders and key opinion leaders in pharmaceutical bioprocessing to participate in a new and unique thought leadership forum, our Virtual Think Tank (VTT) Early Access series. Each VTT panel, comprising professionals from pharmaceutical companies, contract development and manufacturing organizations (CDMOs), and 3M Company, discussed the new 3M™ Harvest RC Chromatographic clarification technology following participation in a beta test program that allowed them early access to work with the product and provide hands-on…

February 25, 2022

Comparison of Gator BLI and Progen ELISA for Quantitation of AAV Serotypes

by

The determination of total capsid titer is one of the critical quality attributes for AAVs used in gene therapy. This application note presents quantitation of AAV serotype 2, 5, 8 and 9 using GatorPrime™ system and Gator™ AAVX probes, and compares the performance with Progen Xpress ELISA assay for the same serotypes. The Progen ELISA kit is commonly used for AAV quantitation and while it performs well, it has several drawbacks for routine operation, viz, need to dilute the samples…

February 24, 2022

Viral Clearance: A WuXi Advanced Therapies Perspective

by

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

by

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

by

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