Search results for " industry"
Article
Evolution of the Monoclonal Antibody Purification Platform
It has been more than a decade since the industry started establishing the process platform. This 31st article in the “Elements of Biopharmaceutical Production” series focuses on evolution of the puri…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
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Operational Excellence: More Than Just Process Improvement
To tackle human-error-caused deviations, the deviation management process was redesigned to bring it into line with current FDA expectations and industry best practices, and to assure that the people …
Article
Essentials in Establishing and Using Design Space
FDA, Guidance for Industry, Process Validation: General Principles
and Practices (2011).
3. S. Chatterjee, “Design Space Considerations,” FDA, AAPS Annual Meeting, October 14, 2012, Chicago, O…
Article
QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Single-use systems are well accepted in today’s manufacturing industry and their widespread use is driven by benefits such as reduced and delayed capital investments as well as by a shift from fixed c…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
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CASSS — An International Separation Science Society
CASSS is a not-for-profit 501(c)(6) professional society made up of over 4,000 industry, academic and public sector professionals in the field of separation science and related fields.
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International Society for Pharmaceutical Engineering
ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit association dedicated to educating and advancing pharmaceutical manufacturing professionals and th…
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International Conference on Harmonization
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmace…