Search results for " drug" in Articles / App Notes
Article
The Development and Application of a Monoclonal Antibody Purification Platform
In addition, we must develop new technologies for ultrafiltration to meet the need for high-concentration drugs used for subcutaneous injection. These are just some of the challenges facing the indust…
Article
QbD and PAT in Upstream and Downstream Processing
…graded from a CPP to a key process parameter (or other lower parameter designation used by different drug sponsors).
Weber (CMC Biologics): For an upstream process, the process of expanding th…
Article
The Lifecycle Change of Process Validation and Analytical Testing
BioPharm International spoke with Hal Baseman, COO and principal at ValSource LLC and co-leader of the Parenteral Drug Association Process Validation Interest Group; Paul Smith, EMEAI laboratory compl…
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The Future of Biopharma
In response, most large pharmaceutical companies are now devoting increasing development efforts on biopharmaceuticals rather than small molecule drugs. Some are now spending 40% or more of their R&D …
Article
Automated Concentration and Diafiltration of Multiple siRNA Samples
Of particular interest to drug discovery is the application of siRNA as a biotherapeutic agent (1–5). To evaluate the suitability and effectiveness of siRNA as a biotherapeutic product, it is of inter…
Article
PDA's Technical Report for Biotech Cleaning Validation
Only a few literature references document the degradation of specific drug active proteins during the cleaning process. However, the literature contains ample evidence that proteins generally will deg…