Search results for " review"
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Ensuring Sterility in Small-Scale Production
Determining the appropriate monitoring locations should be determined through a comprehensive risk evaluation that should periodically be reviewed and updated to reflect the most current operating con…
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Ensuring the Biological Integrity of Raw Materials
Thorough cleaning of equipment, testing, and review of material sources are also important steps to take. Bovine serum, for example, should be sourced from a country with a negligible risk of bovine s…
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
The year ahead is expected to be marked by increased biosimilar development, lower drug prices, and better quality drugs.
The global biopharmaceuticals market was valued at $162 billion in 2014 a…
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Drug Quality Key to Innovation and Access
These issues were highly visible in the debate over FDA approval of Sarepta Therapeutics’ treatment for Duchenne muscular dystrophy; reviewers and senior staffers in the Center for Drug Evaluation and…
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Managing Risk in Raw Material Sourcing
Teva, meanwhile, has developed a systematic risk-based approach for reviewing suppliers, including their efforts in serialization (5).
References
1. “Best Practices for Effective Excipient S…
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Advancing Single-Use Technology Through Collaboration
“We are also providing free consultations to suppliers who have questions about executing their own studies, including upfront reviews of their study protocols,” said Wong. Rather than simply demandin…
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A Q&A with Eric Langer: CMOs Embrace New Technology
However, when reviewing the current development status, and future hurdles for introduction of many emerging continuous bioprocessing technologies, it may be some time before we see them used in mains…
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Managing Biomanufacturing Capacity Expectations
In a Nature Reviews Drug Discovery study from 2013, investigators concluded that more than 60% of companies miss their demand forecasts by at least 40% (3). A significant number of companies were also…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
• Review of critical raw material specifications for adequacy and viral safety acceptance criteria.
• Maintain a detailed supplier auditing and qualification program that includes biosafet…
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Vaccine Development Faces Urgency and Challenges
Conversely, strong state vaccine mandates can work, as seen in a review of the history and impact of childhood vaccination requirements in Mississippi and West Virginia, the only two states to allow o…