Search results for "FDA" in Articles / App Notes
Article
Managing Residual Impurities During Downstream Processing
In addition to these biologics-specific chapters from USP, FDA published draft guidance on elemental impurities in June 2016 (3) following the issuance in 2014 of the International Council for Harmoni…
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Speed and Flexibility Are Dual Goals for Biopharma Operations
To expedite the review of new manufacturing technologies, FDA has initiated efforts to promote early discussion between drug sponsors and the agency to address manufacturing design and development iss…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
FDA approved the first Humira (adalimumab) biosimilar, Amjevita (Amgen), in September 2016, and it was the fourth biosimilar approved in the United States. The European Medicines Agency (EMA) started …
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Establishing Acceptance Criteria for Analytical Methods
• FDA, Analytical Procedures and Methods Validation for Drugs and Biologics (6): “An analytical procedure is developed to test a defined characteristic of the drug substance or drug product against es…
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Vaccine Development Faces Urgency and Challenges
…iver new vaccines to patients, noted GlaxoSmithKline (GSK) Chief Scientist Rino Rappuoli at the PDA/FDA Vaccines conference in December 2015.
Such strategies may accelerate development of a vacci…
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Biopharma Advances Demand Specialized Expertise
Regulatory and business trends
BioPharm: What regulatory changes have positively or negatively impacted biopharmaceutical development/manufacturing processes?
McNally (PPD Consulting): FDA estab…
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Host-Cell Protein Measurement and Control
FDA expects “Whenever possible, contaminants introduced by the recovery and purification process should be below detectable levels using a highly sensitive analytical method” (7). The European Medicin…
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Evaluating Design Margin, Edge of Failure and Process
FDA generally welcomes discussion on design space with applicants; discuss the design space and submission logic with FDA working groups as needed.
References
1. ICH, Q8 (R2) Pharmaceutical De…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
While a pathway has been in place since March 2010, a lack of guidance from FDA regarding specific requirements has created significant uncertainty for biosimilar manufacturers. That uncertainty was s…
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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…