Biopharma Processing & Development In-Depth Focus 2018

• 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.