Search results for " industry" in Articles / App Notes
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Today’s industry and regulatory expectations require that an effective viral risk mitigation strategy be built into the whole manufacturing chain, spanning from the suppliers of crucial raw materials …
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
…Tripartite Guideline Validation of Analytical Procedures: Text and Methodology, and FDA Guidance for Industry, Bioanalytical Method Validation (18, 19, 20). The parameters of the validation included …
Article
Vaccine Development Faces Urgency and Challenges
Scientific advances
To achieve these goals, scientists in academia, government, and industry are moving to tap new genomics technology to reduce the long R&D process and help modernize vaccine dev…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…ant proteins have been the most important factors that have enabled the adoption of CHO cells as the industry’s predominant host for development and manufacturing of therapeutic proteins (17). Howeve…
Article
Innovative Therapies Require Modern Manufacturing Systems
FDA, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base Guidance for Industry, Draft Guidance (CDER, December 2015).
5. US House of Representatives …
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GMP Challenges for Advanced Therapy Medicinal Products
“[This is] weakening the position of the EU academics and industry to collaborate and compete globally in this expanding field.”
Advanced medicines may need the adoption of a different strategy to …
Article
Implications of Cell Culture Conditions on Protein Glycosylation
FDA, Guidance for Industry, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Rockville, MD, Apr. 2015).
4. FDA, Guidance for Industry, Quality Considerations in Demo…
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A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Participants from academia and industry meet and discuss the latest developments in an environment away from the daily routines, rich in scientific quality and engagement, and free from commercial dis…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
FDA, Guidance for Industry, Bioanalytical Method Validation (Rockville, MD, May 2001).
8. D.M. O’Hara et al., AAPS J. 14 (2), pp. 316-328 (2012).
9. R.F. Staack, et al.…
Article
Fluid Handling in Biopharma Facilities
Automating this process into a closed system and out of a laminar flow hood would be of tremendous benefit to the industry.