Search results for " guidance" in Articles / App Notes
Article
Ensuring Sterility in Small-Scale Production
For these small-scale batches, manufacturers need to adhere to the recommended requirements for control of the environment as defined in FDA’s aseptic processing guidance (1), the Parenteral Drug Asso…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Although a plethora of regulatory guidance documents have been enacted governing product safety from adventitious agents (1–16), complete risk elimination has not yet been achieved. Several examples o…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
…(ICH) Q2(R1) Tripartite Guideline Validation of Analytical Procedures: Text and Methodology, and FDA Guidance for Industry, Bioanalytical Method Validation (18, 19, 20). The parameters of the validat…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…n of the production cell lines used for commercial drug substance manufacturing followed the ICH Q5B guidance. In conjunction with protein characterization and quality assessment, the genetic stabili…
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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…
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
CMOs Concerned With Cost of Single-Use Equipment
For example, 13% of CMOs worry for the lack of regulatory guidance on L&E—noting this as their top obstacle. In combination with other concerns about L&E, these could be viewed as the leading technica…
Article
Biopharma Advances Demand Specialized Expertise
Integrating risk-based review, GMP inspection, implementation of quality by design, and the new FDA process validation guidance within one office is expected to significantly change the biopharmaceuti…
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Modern Manufacturing Systems Key to FDA Quality Initiative
OPQ’s Office of Policy for Pharmaceutical Quality (OPPQ) is examining current policies and areas where risk-based regulation and guidance would encourage continuous quality improvement by industry thr…
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New Era for Generic Drugs
Small manufacturers asked FDA for reduced annual facility and filing fees, and several industry executives urged more clarity in how new guidance would be implemented. They offered specific comments o…