Search results for " GMP readiness"

Article Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain. Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…

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 Bioterminology: A Guide to the Biopharmaceutical Lexicon
Bioterminology: A Guide to the Biopharmaceutical Lexicon This lexicon was generated by the editors of BioPharm International magazine. Please feel free to email your suggestions for terms that s…

Article Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals. The manufacture of biopharmaceuticals presents …

Article Biomanufacturing: Demand for Continuous Bioprocessing Increasing
Biomanufacturing: Demand for Continuous Bioprocessing Increasing VALDIS TORMS - STOCK.ADOBE.COM But are innovations sufficient to increase adoption? CMOs are demanding better conti…

Article Industry Adoption of Single-Use Systems Remains Low
Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low. By Feliza Mirasol zli…

Article Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling. By Elizabeth Rivera…

Article Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality. Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…

Article Best Practices for Data Integrity
Best Practices for Data Integrity Optimize practices and meet requirements using electronic data integrity systems. By Jennifer Markarian Maintainin…

Article An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…

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