Search results for " drug"
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…
Article
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…
Resource
The Development of Therapeutic Monoclonal Antibody Products
This report provides a roadmap for the development of a monoclonal antibody product from initial discovery through the filing of an Investigational New Drug Application (IND) or Investigational Medi…
Resource
FDA’s Adverse Event Reporting System (AERS)
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biolog…
Resource
International Conference on Harmonization
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmace…
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