Search results for " variability"
Article
Top Process Development Trends for 2021 and a Look into 2022
It focuses on the evaluation of intra- and inter-batch variability and can be applied to both large- and small-molecule pharmaceuticals.
Bioprocess Development Forum readers also focused on efficie…
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Making Your Bioprocesses More Efficient
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Bioprocess intensification lets you maximize productivity while minimizing one or more key variables of your current biomanufacturing proces…
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Process Development: 2020 Reflections and 2021 Possibilities
Another prominent topic of the year was process variability, which can significantly impact biomanufacturing outcomes and is influenced by various factors, including variations in process parameters o…
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Faster, Smaller, Cheaper: Optimize Your Bioprocess Facility
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Bioprocess intensification lets you maximize productivity while minimizing one or more key variables of your current biomanufacturing process, such as time, volume, or…
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Platform for Purification of VHH-type Antibody Fragments
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Protein A affinity chromatography resins have been used to purify monoclonal antibodies (mAbs) by the bioprocess industry at all scales for a long time. Howev…
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Considerations for Improving Outcome in Biopharmaceutical Process Development
For example, things like streamlining operations, optimizing titers and yields, evaluating cell lines and cell culture media, and controlling raw material variability can play a pivotal role in obtain…
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Understanding and Controlling Raw Material Variation in Cell Culture Media
Manage variability through advanced analytical methods and risk-based assessment.
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Article
Good Manufacturing Practices: Challenges with Compliance
Biologics are complicated to work with because they come from living materials, which have inherent variability. Therefore, the biggest challenge from a GMP perspective is maintaining consistent produ…
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The Importance of Partnering for Bioanalytical Studies
The bioanalytical methods need to be robust enough to work with the variability that comes with such a diverse set of samples.
It is thus important to anticipate these challenges early on while…
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Free On-Demand Webinar: Smart Process Development of Chromatography Steps
Management of process variability through deeper process understanding
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Use of high-throughput methodologies
This toolset can help you overcome some of the challenges with time limit…