Search results for " BPOG"
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Single-Use Extractables and Leachables: Cytiva's Alignment with the BPOG Protocol
In this environment, BPOG has published a proposal for such a standard approach. Learn more how Cytiva has aligned with the BPOG protocol.
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Roadmap Leads to Innovative Biomanufacturing Strategies
For example, when presenting a new idea, the first questions quite often are: Who else have tried this? What is the risk? How will the regulatory bodies view this? Through the collaboration in BPOG, i…
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A Q&A With Jeff Carter on Trends in Single-Use Technologies
…and corresponding analytical techniques across the industry through trade associations like BPSA and BPOG. This development will lead to the increasing availability of high quality single-use materia…
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Evaluating E&L Studies for Single-Use Systems
Many companies have now adopted the BPOG extractables protocol (3) as their user requirement.
Extractables and leachables evaluation
An extractables and leachables evaluation should begin wi…
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Advancing Single-Use Technology Through Collaboration
The BPOG members who have been collaborating about this topic determined that their goal would be to advance the knowledge and application of disposable technology within the next five years to a poin…
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Continued Process Verification for Biopharma Manufacturing
Future Efforts and Improvement
The BPOG CPV example plan prepared by the collaborative team does address some of the complications of implementing CPV and provides recommended approaches, but ques…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
…n of Pharmaceuticals for Human Use (ICH) Q7 guidelines (6), extractable and leachable profiles using BPOG guidelines on single-use components, and bioburden and endotoxin specifications on validated …
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Automating the Biomanufacturing Process
In addition to BPOG’s work, the International Society for Pharmaceutical Engineers, the Standardization Association for Measurement and Control in Chemical Industries, and the German Electrical and El…
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Securing the Single-Use Supply Chain
Industry commitment
Supply-chain security is a top challenge for both BPSA and BPOG moving forward into 2015. The Parenteral Drug Association (PDA) is also working on concepts to facilitate multis…
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Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain.
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…