Search results for "cleaning validation"

Article Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design. By Peter Genest, John Joseph The benefits of adopting single-use technologies in the production of biopharmaceuticals…

Article Trends in Single-use Bioreactors
On the other hand, introducing a single-use bioreactor into a traditional facility can provide benefits such as better flexibility, less downtime, and less time and effort spent on cleaning validation

Article Technology Innovations Improve Process Chromatography Performance
Reducing the costs for cleaning and cleaning validation are also challenges that many big companies and contract manufacturing organizations (CMO)/contract development and manufacturing organizations …

Article Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach. By Cynthia A. Ch…

Article Re-use of Protein A Resin: Fouling and Economics
Mar 01, 2015 By Anurag S. Rathore, Mili Pathak, Guijun Ma, Daniel G. Bracewell BioPharm International Volume 3, Issue 28 In the past two decades, Protein A affinity chromatography ha…

Article Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …

Article Best Practices in Adopting Single-Use Systems
Key considerations for implementing single-use components or platforms when moving from research to process development. The adoption of single-use systems in biopharmaceutical production or…

Article Single-Use Technologies Prove Effective for Viral Vector Process Development
These technologies provide several advantages over stainless-steel systems, including reduced capital investment, elimination of cleaning in place (CIP), and cleaning validation. These advantages, acc…

Article Industry Adoption of Single-Use Systems Remains Low
Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low. By Feliza Mirasol zli…

Article Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important. By Mostafa Eissa The biopharmaceutical industry has witn…

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