Upstream Processing

Ask the Expert: Cell Culture Media Analysis Using Handheld Raman Analyzers

In biopharmaceutical manufacturing, cell culture media supply critical nutrients and maintain pH and osmolality to optimize protein product yield. Because media composition and condition have a strong effect on final biologic product quality and production, biopharmaceutical companies monitor media for lot-to-lot variability. Stability testing for degradation due to light exposure, temperature changes, or shelf-life/time is possible with rapid spectroscopic methods. In an 8 October 2019 “Ask the Expert” webinar, O. Dean Stuart (product manager at Thermo Fisher Scientific) explained how…

Upstream: Make the Right Decisions for Your mAb

Bioprocess decisions made during upstream operations can be difficult to reverse at later, more costly stages of biologic manufacture. They even can require significant backtracking, wasting precious time, labor, and material. Read this Special Report to learn ways to optimize monoclonal antibody bioprocessing upstream. Specifically, you will learn about different tools that small and emerging biotechnology groups can use to ensure robust cell-line selection novel media formulations designed for intensified upstream processing in perfusion modes mixing and delivery solutions that…

eBook: Viral Vectors for Vaccines — A Virtual Conversation on Production and Analysis

Although today’s vaccines are safer, more effective, and more accessible than they were even 20 years ago, the emergence of new, complex pathogens has exposed limitations in traditional vaccine strategies. Viral vector vaccines (VVVs) hold great promise for confronting those now-intractable pathogens. Combining the best features of live-attenuated and DNA-vaccine approaches, these next-generation prophylactics seek to harness the infectivity of non- or low-immunogenicity viruses to shuttle antigen-encoding DNA from target pathogens into host cells. The resulting transduced cells then initiate…

Capacity Analysis for Viral Vector Manufacturing: Is There Enough?

Advanced therapy medicinal products (ATMPs) are engineered to replace defective, disease-causing genes to compensate directly for a genetic defect or to encode a therapeutic protein construct (e.g., chimeric antigen receptor, CAR) for disease treatment. In most instances, a viral vector delivers the engineered genetic payload, targeting cells in situ or ex vivo through cellular modification, expansion, and infusion into a patient. Clinical successes of ATMPs bolstered by regulatory approval of products such as Luxturna (voretigene neparvovec-rzyl, Spark Therapeutics), Kymriah (tisagenlecleucel,…

Analytical Testing Strategies for CAR T-Cell Products

Assay lifecycle development for traditional biopharmaceuticals such as vaccines and monoclonal antibodies (MAbs) has a clearly defined pathway, from preclinical method selection, development, and optimization through the milestones in preclinical phase trials, and finally to postlicensure method evaluations, comparability, and improvements. The analytical development roadmap for nontraditional biologics such as chimeric antigen receptor (CAR) T-cell therapies and gene therapies are not as clearly defined and can present many challenges along the way. Understanding the “what, how, and when” of analytical…

Matrix: The Highly Automated Multibioreactor Solution That Fits to Your Bench Space, Bioprocessing Needs, and Budget

To improve their bioprocess performance, life-science specialists need flexibility in their R&D laboratories because of constantly changing bioprocessing demands. In addition, more experiments need to be performed with more accuracy and reproducibility on less bench space than ever before — and with limited budgets. Therefore, having flexibility in the number of bioreactors that fit available bench space and budget is crucial — along with the flexibility to connect and integrate the right software, sampling tools, and analytical devices. Running multiple…

Making Media a Priority: An Interview with Susan Riley of Advanced Bioprocessing

Susan Riley is vice president and general manager of Advanced Bioprocessing. It’s been a year since Thermo Fisher Scientific’s acquisition of the Advanced Bioprocessing business from Becton Dickinson (BD). Why did Thermo Fisher see the Advanced Bioprocessing (AB) business as a good fit with its life-science offerings? AB has a significant portfolio in premium supplements for cell culture and microbial fermentation. The AB business was seen as a good fit for several reasons: It goes hand-in-glove with Gibco media, for…

Innovative Strategies for Cell Culture Media Preparation

Although the handling and preparation of cell culture media can seem routine, a number of risks are associated with such operations. Identification and mitigation of associated risks can help ensure consistency of performance, minimize likelihood of contamination, and protect employees while enabling greater efficiencies in upstream processes. Here we describe a number of strategies for reducing risks and streamlining media-related workflows. Simplifying Handling of Cell Culture Powders Media preparation typically is quite labor intensive and poses risks related to containment…

eBook: Addressing Production Complexities — Strategies for Working with Difficult and Susceptible Proteins

All proteins are complex — but some are more complex than others, particularly when it comes to recombinant protein expression and production in commercial quantities. What works in a research laboratory to make a milligram of pure protein for study won’t necessarily work on a manufacturing floor to make kilogram batches for drug-product formulation. An increasing number of technological options are available, however, from a simple switch in expression host or adding folding steps in downstream processing to special genetic…

eBook: Bioassays for Biopharmaceuticals: Finding Best Practices in a Quality Systems World

Bioassays are complex and challenging experiments to run reliably with accurate and dependable results. Consistent performance requires a controlled environment and qualified reagents; skilled analysts who understand cell physiology, regulatory requirements, and the latest techniques; and assay protocols that are intelligently developed, characterized, and validated. Here, BPI’s senior technical editor discusses bioassay best practices with representatives of the Biopharmaceutical Emerging Best Practices Association (BEBPA) organization. Topics span quality by design, assay validation, cell banking, potency testing and host-cell protein monitoring,…