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In addition to these biologics-specific chapters from USP, FDA published draft guidance on elemental impurities in June 2016 (3) following the issuance in 2014 of the International Council for Harmoni…

Article 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…

Article Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
As of February 2017, FDA lists 68 approved mAbs, and approvals have been increasing each year since the late 1990s (3). mAbs are comprised of several domains that contribute to their function. The Fab…

Article 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…

Article Vaccine Development Faces Urgency and Challenges
Efforts to establish more reliable and efficient supplies of seasonal influenza vaccine in the United States, moreover, have led to development and FDA approval of the first US adjuvant flu vaccine. …

Article 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…

Article Host-Cell Protein Measurement and Control
Jun 01, 2015 By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem BioPharm International Volume 28, Issue 6, pg 32–38 Host-cell proteins (HCPs) constitute a major part of proce…

Article 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…

Article 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…

Article 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…

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