Search results for " knowledge"
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Biopharma Advances Demand Specialized Expertise
The knowledge gap
BioPharm: In what areas do you see knowledge or expertise gaps in current biopharmaceutical companies? Why do these gaps exist?
Lorimer (Patheon Biologics): There is a gap in t…
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QbD and PAT in Upstream and Downstream Processing
It should be noted that knowledge of an association between cell-culture steps with certain product quality attributes is not a result of implementing a QbD approach but, rather, a result of knowledge…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
How do you ensure that all those different groups know what you're doing and why it's been done or how it's been done? A lot of times that knowledge transfer, as it's called, doesn't get to different …
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Optimizing Late-Stage and Commercial Cell-Culture Processes
It is also a challenge to respond to evolving concerns on product quality attributes as new knowledge is gained.
Finally, raw material variability, including trace metal impurities in defined m…
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Roadmap Leads to Innovative Biomanufacturing Strategies
The best way to do this, is through collaboration and knowledge sharing. Moreover, the different groups (biomanufacturer, supplier, academia, and regulators) have different perspectives and focus area…
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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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Establishing Acceptance Criteria for Analytical Methods
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Knowing what is the allowable contribution of the method error in drug performance becomes crucial when building product knowledge, process understanding, and the associated long-term product l…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Risk can be assessed by comparing test results with previous experience, knowledge, and through the use of control procedures. While CQA analysis is typically performed in a core analytical lab, there…
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Robust Optimization, Simulation, and Effective Design Space
Developing product knowledge and process understanding is at the heart of modern drug development. Establishing a clear line of sight between critical quality attributes (CQAs), process parameters, an…
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Improving PAT for Biologics
“By working closely with manufacturers of high-throughput bench scale systems, we are currently making them more suitable for achieving increased process knowledge while simultaneously reducing the la…