Search results for " guide"
Article
Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…
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CoAs Help Secure the Supply Chain
IPEC, Certificate of Analysis Guide for Pharmaceutical Excipients, International Pharmaceutical Excipients Council (IPEC, 2013).
2. WHO, Guidelines on the Implementation of the WHO Certification…
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Preclinical Evaluation of Product Related Impurities and Variants
The selection of resin, as is known, is guided by the physicochemical properties of the mAb product under investigation. In this case study, the mAb product had the following characteristics: pI, 7.9-…
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3rd BioProcessing Asia Preview: Q&A with John Curling
They all have long-term experience in biopharmaceutical development in Asia and iconic academics with consultative roles will guide the BPA 2018 program.
The session titles have also recently be…
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Reliability Rooms and the Move to Proactive Supply Chain Management
These correlations, and thresholds, are then used to guide inventory stocking and business continuity planning.
Using demand to track risk
Demand and planning can be used to track risk. The RRs…
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Roadmap Leads to Innovative Biomanufacturing Strategies
… and commercialize new technologies; and regulators ensure that new advancements conform to existing guidelines or develop new guidelines in collaboration with industry, if required. Thus it is impor…
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Being Thorough When Transferring Technology
The technology transfer procedures implemented are typically guided by International Council for Harmonization (ICH) Q10 or equivalent guidance from other regulatory authorities. This guidance is prac…
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Managing Risk in Raw Material Sourcing
“Our efforts are focused on compliance with the International Council for Harmonization’s (ICH) Q7 (for APIs) and IPEC (for bulk pharmaceutical excipients) guidelines to continuously improve our syste…
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Affinity chromatography Handbook - Vol. 3: Specific Groups of Biomolecules
Practical information is given as a guide towards obtaining the desired results.
Download the handbook
Article
Framing Biopharma Success in 2016
Industry feedback to the draft guidance reflected concerns about how FDA will use the reported data to guide further regulatory action, what players in the supply chain were responsible for reporting …