Search results for " production" in Resources
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Plasma Product Biotechnology Conference
The Plasma Product Biotechnology Conference Series, now in its 12th year, will provide a topical and stimulating program detailing the latest developments of importance to the industry. The sessions…
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The Development of Therapeutic Monoclonal Antibody Products
This report provides a roadmap for the development of a monoclonal antibody product from initial discovery through the filing of an Investigational New Drug Application (IND) or Investigational Medi…
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Guidance for Industry: Quality Considerations in Demonstrating Protein Product
FDA's guidance for Industry Quality Considerations in Demonstrating Protein Product
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Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom's government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. T…
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Recovery of Biological Products XIX Conference
This international conference—taking place from July 12–17, 2020 in Rome, Italy—provides exposure to the latest developments in bioprocessing with a focus on downstream processing and aspects that aff…
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FDA’s Adverse Event Reporting System (AERS)
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biolog…
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Protein A Fiber Chromatography from Research to Scale-up and Manufacturing of Monoclonal Antibodies
The new Protein A fiber chromatography format allows for quick purification of many samples because of its short cycle times. This makes the pre-packed, small-scale Protein A fiber unit a versatile …
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Bio-Process Systems Alliance
The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led corporate member trade association dedicated to encouraging and accelerating the adoption of single use manufacturing te…