Search results for " ensuring sterility bioproduction"

Article Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches. By Susan J. Schniepp Q. I am a …

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 The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment. By Jennifer Markarian …

Article Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems. By Jerold M. Martin Single-use technologies (SUT) have made significant inroads in …

Article Automating Bioprocesses
Automation of stainless-steel systems and single-use systems differs in complexity. By Jennifer Markarian Both upstream and downstream biopharmaceutical processes have conventionally used st…

Article Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain. Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…

Article Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages. Cynthia A. Challener  Upstream viral-vector processes can have sig…