Search results for " documentation"

Article Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies FDA works with industry on strategies for assuring high-quality regenerative medicines. By Jill Wechsler …

Article Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures. By Cynthia A. Challener Manufacture of protein and other biologic drug substances via …

Article Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International Humans represent the greatest risk for microbial contamination in an aseptic process. Aseptic processing has garnered some increased scrutiny…

Article State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality? The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…

Article FDA Seeks Metrics to Define Drug Quality
Further signals of potential quality or compliance issues may appear as increased documentation errors, unplanned quarantine shipments, or complaints per units produced. The next level captures higher…

Article HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
…as ease of data sharing and collaboration, streamlined review and witnessing processes, standardized documentation, and long-term data preservation. SUMMARY MAbs are under develop…

Article Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…

Article FDA Provides Guidance on Bispecific Antibody Development Programs
The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs. FDA published final guidance …

Article Good Manufacturing Practices: Challenges with Compliance
WrightStudio/Stock.Adobe.com The complexity of biologics and the use of new technologies present challenges for complying with CGMPs. By Lauren Lavelle …

Article Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes. By Susan Haigney natali_mis/Stock.Adobe.com Regulators have been en…

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