Search results for "Viral clearance studies"

Article Development of Purification for Challenging Fc-Fusion Proteins
Initial viral clearance studies for Fc-fusion A using flow-through cation exchange with conditions previously identified revealed ≥ 3.9 log reduction value (LRV) for X-MuLV. Relatively limited clearan…

Article Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes. By Susan Haigney natali_mis/Stock.Adobe.com Regulators have been en…

Article Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3 Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

Article Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex thera…

Article Case Study: Virus Reduction of an Affinity Capture Step
Evaluating how much a process step contributes to viral clearance is an essential part of process validation. For this reason, there is an industry need to perform effective viral clearance studies. I…

Article Report from the 6th International HTPD Conference
Indeed, viral clearance studies are important, but costly and time-consuming tasks in downstream process development. Today, virus surrogates are being used more and more, yet if mechanistic modeling …

Article The Development and Application of a Monoclonal Antibody Purification Platform
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies. The following ar…

Article Going Small to Achieve Success on the Commercial Scale
Qualified scaled-down models are instrumental for conducting such characterization work, as well as for viral clearance studies, continuous process improvement, and for conducting impromptu investigat…

Article From Darwin to Recombinant Fc Multimers
Topics from a Darwinistic viewpoint on how business models are evolving in the Life Science industry to breakthrough research data from Momenta Pharmaceuticals on a recombinant trivalent Fc protein …

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