Whitepaper/App Note

Whitepaper: Downstream biopharmaceutical operations

Posted: 1 December 2017 | | No comments yet

The work presented here investigates the development and application of new bioprocess analytics in accordance with the aims of QbD…

The Process Analytical Technology (PAT) initiative of the U.S. FDA provides a framework for implementing principles of “Quality by Design” (QbD), which promotes quality assurance through understanding and controlling the critical process parameters that affect a biologic product’s critical quality attributes. To this end, rapid, non-destructive spectro-scopic methods offer significant monitoring and control options for bioprocess unit operations such as in situ monitoring of purification cycles, buffer identification, protein aggregation, product identification, and quality control. 

Extending process understanding to downstream bioprocesses is vital to ensure high-quality biological products. Current research is focused on gaining a better understanding of biologic downstream steps by quantitatively measuring key analytes such as amino acids, sugars, and proteins. Similar technology has been used to trend nutrient and metabolite concentrations in situ and in real time during upstream bioprocessing stages. Raman spec-troscopy is uniquely useful for biotechnology QbD applications because it enables fast, non-destructive monitoring and control.

The whitepaper is restricted - login or subscribe free to access

european pharmaceutical review magazine cover issue 2 2018Thank you for visiting our website. To access this content in full you'll need to login. It's completely free to subscribe, and in less than a minute you can continue reading. If you've already subscribed, great - just login.

Why subscribe? Join our growing community of thousands of industry professionals and gain access to:

  • bi-monthly issues in print and/or digital format
  • case studies, whitepapers, webinars and industry-leading content
  • breaking news and features
  • our extensive online archive of thousands of articles and years of past issues
  • ...And it's all free!

Click here to Subscribe today Login here

 

Related organisations

Send this to a friend