Search results for " low pH" in Articles / App Notes
Article
Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
This week Process Development Forum talks about Protein A with Jonathan Royce, business leader for Cytiva chromatography resins.
mAb purification platforms are very well established, and …
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Immediate, Flexible Capacity with Hydrated Buffers and Process Liquids
Fluids used in bioprocessing are typically prepared in-house by hydrating powders purchased from suppliers. Historically, bioprocessing facilities have prepared buffers and process liquids in-house …
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Extractables Studies for Single Use Systems Used in ADC Manufacturing, Part 1
Single‑use (SU) systems have great potential in antibody‑drug conjugates (ADC) manufacturing. The use of organic solvents in the ADC process might , however, raise questions about potential leac…
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Improvements in Protein A Chromatography
Process Development Forum speaks about Protein A chromatography with Glen Bolton, Scientific Director at Amgen. Bolton recently published a paper “Role of more than 40 years of improvement in Protei…
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Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
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Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …
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Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
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Managing Risk in Raw Material Sourcing
Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.
By Agnes Shanley
Choosing excipients and supplie…
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Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
By Thomas A. Little, PhD
To control the consistency and quality o…
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Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
By Claudio Denoya …