Search results for "FDA" in Articles / App Notes
Article
Good Manufacturing Practices: Challenges with Compliance
Obstacles to compliance
BioPharm: What challenges do you see in complying with FDA’s CGMP regulations for biopharmaceutical manufacturing?
Smith (Catalent): In general, it is not difficult t…
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The Importance of Partnering for Bioanalytical Studies
FDA has issued guidance documents detailing the scope of bioanalytical method validation required for PK/PD endpoints, but it is also important to consider other regional guidance documents (e.g., Eur…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Earlier this year, FDA issued a statement revealing that there are already more than 800 active cell-based or directly administered gene therapy investigational new drug applications (INDs) currently …
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Evaluating Surface Cleanliness Using a Risk-Based Approach
Cleaning validation regulatory guidance
FDA’s 1998 cleaning validation guidance document focuses on general aspects and qualification of the cleaning process (1). The design and post-validation mo…
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Bioburden Control in the Biopharmaceutical Industry
Up-to-date lists of product recalls due to contamination by objectionable microorganisms are provided by FDA (1). The Center for Food Safety and Applied Nutrition (CFSAN)—under FDA—provided a comprehe…
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Efforts Accelerate to Streamline Postapproval Change Process
FDA and other regulators have sought to address these issues by encouraging industry adoption of continual improvement and quality-by-design approaches, along with change management protocols and life…
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Aseptic Processing: Keeping it Safe
Aseptic processing has garnered some increased scrutiny from FDA in recent years, primarily because it is considered a high-risk activity by the agency, says Rainer Newman, consultant at Aseptic Proce…
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Continuous Manufacturing: A Changing Processing Paradigm
FDA support for quality improvements
FDA has been a strong supporter of continuous processing as early as 2004 when it released Pharmaceutical cGMPs for the 21st Century–A Risk-Based Approach. In …
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Vaccine Development and Production Challenges Manufacturers
Researchers are advancing new vaccines for Ebola and other devastating diseases, while manufacturers work with FDA to bring to market new products to combat dangerous infections and strategies to impr…
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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…