Search results for " sterile"
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
…rd harvest and downstream systems for clarification, tangential flow filtration, chromatography, and sterile filtration, according to Ramaswamy.
Both mAb bioprocessing and viral-vector manufact…
Article
Automating the Biomanufacturing Process
As automation in biomanufacturing becomes more important, so does the need to integrate process data.
By Feliza Mirasol
unlimit3d/Stock.Adobe.com
Biomanufacturing proc…
Article
Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry.
By Jennifer Markarian
The implementation of sing…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
…
Article
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
This article highlights 15 years of changes in biopharmaceutical manufacturing.
By Ronald A. Rader, Eric La…
Article
Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…
Article
Reducing Cross-Contamination Risks in Process Chromatography
Reducing Cross-Contamination Risks in Process Chromatography
Single-use systems provide replaceable fluid paths.
By Cynthia A. Challener
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Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling.
By Elizabeth Rivera…
Article
Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …
Article
Ensuring the Biological Integrity of Raw Materials
Sasges points out the plants are not sterile, either, due to exposure to soil, animals such as field mice, bird feces, human contact, and other environmental sources of contamination. Sasges says simp…