Search results for " guidance"
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Avoiding Investigational Failures and Discrepancies
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
By Walt Murray,…
Article
Being Thorough When Transferring Technology
The technology transfer procedures implemented are typically guided by International Council for Harmonization (ICH) Q10 or equivalent guidance from other regulatory authorities. This guidance is prac…
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Speed and Flexibility Are Dual Goals for Biopharma Operations
In a draft guidance for industry, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base (December 2015), the agency outlined a process for biopharmaceutica…
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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…
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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…
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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.…
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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…