Search results for " quality"

Article What is process development?
Those activities must be combined with the right analytics, so you can accurately measure what you’ve identified as your product’s critical quality attributes (CQAs) as you develop and refine your pro…

Article Cell-free Expression Systems Pose Cell Culture Alternative
…al, bypasses limitations on molecular transport across the cell wall, and enables consistent product quality by avoiding stochastic cell growth issues, the professors comment. In addition, Jewett not…

Article Genetic Vaccine Platforms Demonstrate Their Potential
“The availability of trained, regulatory-compliant GMP manufacturing staff and quality control and quality assurance personnel is a critical success factor,” he says. Much investment in facilities wil…

Article The Importance of Process Intensification and PAT for Achieving Real-Time Release
Workflows, capital and operating expenses, product quality, and waste production can all be positively impacted by the efficiency gains possible with process intensification. …

Article How To Execute Successful Data Migrations
By taking proactive steps to fully plan, scope, design, and develop a formal quality assurance (QA) approach, a team will be poised to make their next migration a great success. The importance o…

Article Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Single-use systems involve a greater reliance on the quality and robustness of the vendor’s supply chain, and concerns about potential problems caused by extractables and leachables, especially during…

Article Driving Improved Access to Biosimilars
The agency also published draft guidance on the analytical methods to be used to establish biosimilar comparability and quality (12). According to reports on May 13 and May 21 in the Regulatory Affair…

Article Automating the Biomanufacturing Process
Control has been manifested mainly in minimizing manual interactions and preventing operator error, to prevent variability in production and in product quality that would require correction. Today…

Article The Challenge of Disruptive Technologies in Bioprocessing
…ivery, supply chain logistics, full [good manufacturing practice] GMP documentation, high consistent quality, and easy customer relations,” she asserts. Disruptive innovations “Keeping in min…

Article Biopharma Seeks Balance
Peters A biopharma company answers to multiple masters: the patient who depends on effective drug products for health or survival; regulatory authorities that monitor quality; …

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