Search results for " production"
Article
Methods Accelerate Biosimilar Analysis
Methods Accelerate Biosimilar Analysis
Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
By Mario DiPaola, …
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Perfusion in the 21st Century
Perfusion was first introduced in the 1980s to enable the production of sensitive proteins that degraded when left in bioreactors under batch and fed-batch conditions. Around the same time, continuous…
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical manufacturers’ change-control systems are designed to ensure that any changes to raw materials, product contact materials, manufacturing methods, product tests, and production equipment…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
If those specific candidates are not successful in the clinic, those facilities must be able to quickly switch to production of different vaccine candidates that have been approved.
While this app…
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Applying GMPs in Stages of Development
Applying GMPs in Stages of Development
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, …
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Modern Manufacturing Systems Key to FDA Quality Initiative
Agency officials have urged biopharmaceutical manufacturers for more than a decade to adopt more reliable and efficient advanced manufacturing technologies capable of ensuring consistent high-quality …
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Continued Process Verification for Biopharma Manufacturing
Its recommendations are based on a typical cell culture production process for making a fictitious monoclonal antibody (mAb) product (3). Although this model plan does not provide examples of all aspe…
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Manufacturers Struggle with Breakthrough Drug Development
If no transfer of production is needed, that will save a lot of time, he observed, but all facilities have to meet standards.
Seeking flexibility
FDA has established many standards and requireme…
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Reviewing the Importance of Biosimilarity and Interchangeability
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
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New Therapies Present Scaling Challenges
However, differences in manufacturing cycles for emerging therapies, compared with that of the traditional monoclonal antibody (mAb) therapeutic, calls for different strategies to increase production.…