Conventional ultraviolet–visible spectroscopy (UV-vis) instruments use fixed optical pathlengths to measure analyte concentrations in biological samples. As Paul Mania (bioanalytics application specialist at Repligen) pointed out during an April 2022 presentation, such an approach requires sample dilution, which introduces risks for error and increases operator workload. Mania explained how the CTech SoloVPE instrument measures analyte concentrations at line without need for dilution, simplifying and accelerating analysis of samples from several downstream operations. Mania’s Presentation Traditional UV-vis instruments measure analyte absorbance…
2022
Improving Viral Vector Manufacturing: Modeling Costs to Help Optimize Processes
Manufacturing costs remain high for gene therapies delivered by adenoassociated virus (AAV) vectors. The biopharmaceutical industry must minimize such expenses because they account for significant proportions of the high prices that patients pay for treatment. During a June 2022 webinar, Emmanuelle Cameau (leader for cell and gene therapy strategic technology partnerships at Pall Corporation) joined Maxime Dumont (cell and gene therapy product manager at webcast sponsor Polyplus-transfection) to describe their companies’ efforts to model AAV manufacturing costs. Cameau and Dumont…
Using Cutting-Edge Tools to Optimize Cell-Culture Media Development
Although culture-media optimization accounts for a relatively small part of process development, selections made at that stage strongly influence overall bioprocess productivity. Yaron Silberberg (chief scientist at the Ajinomoto Genexine CELLiST Solution Center) joined BPI in July 2022 to present strategies for enhancing media performance. He focused on how emerging tools for statistical analysis and process control facilitate media development for cultures based on Chinese hamster ovary (CHO) cell lines. Silberberg’s Presentation Because materials applied during cell-line development are not…
Mass Photometric Analysis of Adenoassociated Virus Capsids
Current production processes for gene therapies based on adenoassociated virus (AAV) vectors generate many empty capsids. That problem complicates vector purification and diminishes product safety and quality. In a June 2022 webinar, Gareth Rogers (product manager at Refeyn Ltd.) observed that developers could benefit significantly from analytical instruments that assess empty-to-full (E:F) capsid ratios rapidly. He explained how the SamuxMP mass photometry system (Photo 1) could address such needs. Kirsty McManus (senior scientist in AAV characterization at Pharmaron Gene Therapy)…
A Flexible, Intensified Seed Train to Boost Upstream Productivity
Biopharmaceutical companies continue to invest significantly in technologies that support process intensification (PI), including equipment for high-density and perfusion-mode cell cultures. During a July 2022 Ask the Expert webinar, Yuliya Mikhed (product manager for Biostat RM bioreactors at Sartorius) highlighted drivers for PI solutions, then described how an intensified modular seed train could help users to increase cell culture productivity and flexibility while reducing cost of goods (CoG). Mikhed’s Presentation Sartorius customers have identified several drug development “pain points.” Biologics…
Market Growth for Biopharmaceutical Media, Sera, and Reagents
Bioprocessing materials such as cell-culture media, sera, and reagents are used in the development of different drug products such as recombinant proteins, immunotherapies, and regenerative medicine. Biopharmaceutical research materials include DNA/RNA isolation reagents, chemicals, buffers, stains, and washing solutions. Media provide nutrients essential for cell growth in culture. Advancements in culture media (both serum-based and serum-free) have enabled researchers to culture different types of cells and microorganisms, including mammalian and bacterial host cells for protein expression (e.g., Chinese hamster ovary…
20th Anniversary Issue: From the Editors
Founded in the middle of 2002, BPI published its first issue in January of 2003. Our 20th-anniversary issue thus takes the form of a state-of-the-early-21st-century industry report. Assembling this content has reinforced our appreciation of the remarkable paths that this industry has taken and continues to take — and our journey alongside it. Having worked as editors in this industry since August 1988 (Montgomery) and September 1996 (Scott), we’ve found it difficult to maintain a chronological grasp of developments —…
The Evolving Manufacturing Landscape: Reflections from PDA President and CEO
The past 20 years have been a period of rapid change and development in the world and in the biopharmaceutical industry. One of the biggest changes has been the introduction of a pathway for biosimilars in the decade after 2010. Before that, no provision for “generic” versions of biologics existed. The European Medicines Agency (EMA) approved the first monoclonal antibody biosimilar in 2013, and the US Food and Drug Administration (FDA) followed with its first approval in 2015. Those approvals…
Transforming the Biopharmaceutical Development Roadmap
Biopharmaceutical analytical methods have improved significantly since the early 1990s. Techniques and fundamental mechanisms largely have remained the same, but modern analytical tools are delivering better insights into drug-product characteristics thanks to improved reagent quality, method intensification, and automation. Harmonized regulations and the revolutionized role of contract development and manufacturing organizations (CDMOs) also continue to support bioprocess transformations. Improved Analytics and Standardized Single-Use Equipment Today’s analytical methods provide high resolutions and deliver reliable results quickly. For example, sodium dodecyl sulfate–polyacrylamide…
Reflections on the Evolution of Biopharmaceutical Manufacturing: A Virtual Roundtable with Scientists from Sartorius
As a trusted partner in the life-sciences industry, Sartorius has contributed significantly to the evolution of biopharmaceutical manufacturing. To reflect on the rich history of the industry, we arranged a virtual roundtable. Based on shared questions, we corresponded about what we considered to be the most important scientific, technological, and operational developments in the past 20 years of bioprocessing. We also reflected on the emergence of new modalities and how such products are likely to shape the future of the…