Search results for " guidance" in Articles / App Notes
Article
Eliminating Residual Impurities Starts with a Strategic Plan
“In the latter case, for instance, consideration must be made for total HCP levels per regulatory guidance, but also for any single HCP of particular concern, for which a more specific monitoring appr…
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An Analytical Approach to Biosimilar Drug Development
The major regulatory authorities have issued guidance documents that clearly outline the expectations for developing a biosimilar. They emphasize that a step-wise approach should be taken to demonstra…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA further outlined in new guidance [3] issued in July 2018 what manufacturing information is needed to support clinical development on chemistry, manufacturing, and control (CMC) information for inv…
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Understanding Validation and Technical Transfer, Part 3
A consultation document [2]published by the European Commission (3) and an FDA guidance document on human somatic cell therapy and gene therapy (4) provide useful information for developing validation…
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Biosimilars to Drive Modern Manufacturing Approaches
BsUFA also sets timeframes for FDA to issue important guidance documents on biosimilar naming and labeling. And new guidance documents are scheduled on standards for achieving product interchangeabili…
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Defining Risk Assessment of Aseptic Processes
In September 2004, FDA finalized their guidance for industry titled Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (1).
This document placed considerable e…
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Innovative Therapies Require Modern Manufacturing Systems
The funding bill further instructs FDA to finalize guidance on biosimilar development and to do more to prevent drug shortages (1). And it puts a hold on FDA consideration of new therapies that use ge…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Specifically, FDA outlines in the aforementioned guidance that protein aggregates elicit an immune response in humans through the following mechanisms: by causing B-cell activation as a result of cros…
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FDA Approves First Biosimilar
It was implied by speakers at the March 6 meeting that switching from one drug to another may be the focus of the forthcoming draft guidance on interchangeability. The formation of drug-specific antib…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
The most recent FDA (1) and International Conference on Harmonization (ICH) (2-4) guidance documents advocate a new paradigm of process validation based on process understanding and control of paramet…