Biopharma Processing & Development In-Depth Focus 2018
In this In-Depth Focus; enabling the manufacture of robust biologic drug products, automating biopharmaceutical development, and greater compatibility and ease of use for bioproduction monitoring of monoclonal antibodies.
- Enabling the manufacture of robust biologic drug products
Patients and caregivers expect that drug products are safe, efficacious, deliver the same performance as described on the label, perform consistently over the proposed shelf-life and are manufactured in a manner by which quality can be ensured. The quality, safety and efficacy of any product can only be ensured through a comprehensive understanding of the biology of the drug, its mechanism of action (efficacy) and dose-response relationship (safety).
- Automating biopharmaceutical development: from early stage to QC
The development of a well-controlled, large-scale biopharmaceuticals production is dependent upon extensive characterisation of molecules and the associated process. Additionally, the number of biosimilar candidates is rising quickly as patents expire; this development pathway is placing a heightened emphasis on biophysical characterisation to prove similarity. This includes primary structure verification, detection of product-related impurities, and evaluation of process-related impurities.
- Bioproduction monitoring for monoclonal antibodies just got easier
Driven by the need for more robust and efficient analytical methods, bioproduction facilities for recombinant monoclonal antibodies and antibody-drug conjugates are demanding greater method compatibility and ease of use.
This In-Depth Focus is restricted - login or subscribe free to access
Thank 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!