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…

Article The Importance of Partnering for Bioanalytical Studies
Bose (Emery Pharma): On a broader perspective, FDA requires PK, toxicokinetic, or biomarker concentration evaluation through bioanalytical studies. It is critical that the data [are]generated via phas…

Article 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 …

Article Evaluating Surface Cleanliness Using a Risk-Based Approach
Along with the process lifecycle approach, other guides have been issued by FDA and the International Council for Harmonization (ICH), which include the concepts of quality by design (QbD), risk manag…

Article 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…

Article Efforts Accelerate to Streamline Postapproval Change Process
To spur the Q12 process, FDA in 2015 issued a draft guidance on defining and reporting ECs (2). The guidance describes which elements of a control strategy could be considered ECs necessary to assure …

Article 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…

Article Continuous Manufacturing: A Changing Processing Paradigm
In addition to reduced inventory, lower capital costs, a smaller ecological footprint, and more flexible operation, FDA is an advocate of the fact that continuous manufacturing reduces manual handling…

Article 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…

Article 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…

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