Search results for " process" in Articles / App Notes
Article
Bioburden Control in the Biopharmaceutical Industry
…-filters rating and risk assessment studies that should be assessed for both upstream and downstream processes.
Good Practices in the Biopharmaceutical Industry
Because bio/pharmaceutical pro…
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Cell detachment is probably one of the most relevant processes hindering a faster development for cell-based biotechnology. In this article, the authors focus on different strategies available for ani…
Article
A Bright Future for the Plasma Fractionation Industry
Improvements in more established process operations, such as filter press operation and chromatography processes, were also reported.
Among the quality and regulatory trends, Quality-by-Design (…
Article
Early Communication with Regulators is Essential for SMEs
The importance of early dialogue with regulators
Companies are encouraged to contact the agencies as early as possible during the drug-development stage to ensure that their manufacturing proces…
Article
Download your Mechanistic Modeling eBook
Mechanistic models use computer simulations to decrease the number of experiments needed during process development. The simulations are based on known physiochemical phenomena involved in chromatogra…
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Good Manufacturing Practices: Challenges with Compliance
Therefore, the biggest challenge from a GMP perspective is maintaining consistent product quality, as this is dependent on the incoming raw material as well as manufacturing processes. When you add in…
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Successfully Moving Regulated Data to the Cloud
The main reason for this is the ‘extra’ information and workflow processes that the electronic systems can easily provide over paper when configured and used appropriately. Lots of additional informat…
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Supply Chain Challenges for Single-Use Systems
BioPharm International spoke with Andrew Bulpin, head of Process Solutions at MilliporeSigma; Jeff Carter, strategic project leader at Cytiva; Eric Isberg, director of Life Sciences at Entegris; and H…
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Applying GMPs in Stages of Development
We have clients with products in various stages of development that are using multiple contracts with multiple services providers for various stages of the manufacturing process. I always struggle wit…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
An FDA advisory committee voted unanimously to recommend approval of Novartis’ new CAR-T, despite concerns about the firm’s ability to process patient T-cells consistently and safely (1). Similar issu…