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In addition to these biologics-specific chapters from USP, FDA published draft guidance on elemental impurities in June 2016 (3) following the issuance in 2014 of the International Council for Harmoni…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