Search results for " FDA"
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Guidance documents from regulatory health authorities, such as FDA and the European Medicines Agency (EMA), emphasize the importance of extensive analytical characterization in showing the similarity …
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Ensuring Viral Safety of Viral Vaccines and Vectors
In 2014, using next-generation sequencing (NGS), FDA’s Center for Biologics Evaluation and Research (CBER) retrovirus laboratory identified a novel rhabdovirus in Spodoptera frugiperda type 9 (Sf9) ce…
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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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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In addition to these biologics-specific chapters from USP, FDA published draft guidance on elemental impurities in June 2016 (3) following the issuance in 2014 of the International Council for Harmoni…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
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…
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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
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.
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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…
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…