Search results for " low pH" in Articles / App Notes

Article Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities. By Feliza Mirasol Ensuring viral clearance (i.e., removal) in downstream purification has becom…

Article Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency. By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore Virus-like…

Article Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption. By Cynthia A. Challener alexlmx a- Stock.Adobe.com Process analytical technology (P…

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 Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …

Article Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
This week, the Process Development Forum talks with Günter Jagschies, Strategic Customer Relations Leader, Cytiva, about the biopharmaceutical market in Asia.  The Asian market is most often s…

Article Contract Manufacturing Through the Years
Contract Manufacturing Through the YearsHow has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hoHow has the bio/pharmaceutical contract ma…

Article Mechanistic Modeling of Preparative Ion-Exchange Chromatography
By Anurag Rathore, Vijesh Kumar Among the various downstream processing unit operations that are used for purification of biotech products, chromatography is uniquely capable of providing resolu…

Article Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
By Catherine Shaffer Four biosimilars have been approved for the market by FDA as of February 2017, and more are in the pipeline. Now that biosimilars are here to stay, manufacturers are devel…

Article An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…

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