Search results for " GMP"
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
At its simplest, the answer requires a comparison of the tasks, labor time, labor rate, raw materials, and overhead to pack a glass column on site and prepare it for use in a GMP suite with a similar …
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
… for one candidate, including the necessary mammalian cell culture facility built in compliance with GMP regulations and a highly educated and experienced workforce, according to Kim. “Since 2002, we…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
Common quality assessors and GMP inspectors, however, usually do not have such knowledge, the study noted.
Design space verification
Both regulators and industry executives at the meeting conced…
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Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…
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Biotechnology Innovation and Growth in Israel
Key regulatory considerations
New drugs registered in Israel, including biologics, must meet European Union (EU) standard GMPs in terms of quality and efficacy to ensure public safety. In ad…
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Trends in Downstream Bioprocessing
…nd permit cost-effective biosimilar manufacturing, as well as reduced overall bioprocessing costs at GMP level quality.
References
1. BioPlan Associates, “2013 Biotechnology Industry Council …
Article
Operational Excellence: More Than Just Process Improvement
FDA Commissioner Margaret Hamburg told participants at the Annual Meeting of the Generic Pharmaceutical Manufacturers Association that the agency will increasingly focus on GMPs to improve drug qualit…
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Navigating Emerging Markets: Middle East and North Africa
Enforcement remains an issue, and the EU has rejected several of Turkey’s GMP certificates.
The Pharmaceutical Research and Manufacturers of America (PhRMA) has flagged Algeria and Lebanon as b…