Search results for " downstream"
Article
Applying GMPs to the BioPharma Supply Chain
They need to understand how variability in raw material quality can have a significant downstream impact on bioprocessing capability and biopharmaceutical product safety.
Traceability, visibility,…
Article
Raw Material Variability
Many of these issues would be upstream in the cell-culture or fermentation step but could also be downstream in purification. The ‘blackbox’ nature of upstream processes makes things doubly difficult.…
Article
Q&A with Industry Leaders: Rita Peters
Strategies to connect upstream and downstream operations and extend continuous bioprocessing were popular topics in educational sessions at Interphex as were well-attended and interest was strong.
…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
The author highlights the top 10 outsourcing trends revealed during a survey of biopharmaceutical manufacturers.
The biopharmaceutical industry is changing the way it manufactures. According to …
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
Elucidating Biosimilars Characterization
…differences regarding the manufacturing processes, be it cell lines used, media used, differences in downstream processing or processing between the innovator and the biosimilar process will undoubte…
Article
The Future of Biopharma
The more than 100 trends identified were categorized as follows:
• 24% downstream process improvements
• 22% single-use implementation and improvements
• 24% analytical methods
• 30% o…
Article
PDA's Technical Report for Biotech Cleaning Validation
For these reasons, limits for the manufacture of bulk actives in biotech are generally established based on industry standard practice of about 5–10 ppm TOC for upstream processes and 1–2 ppm for down…