loading page

From cell line engineering to the formulated drug product: The art of manufacturing therapeutic monoclonal antibodies
  • +3
  • Stefania Carrara,
  • Michael Ulitzka,
  • Julius Grzeschik,
  • Henri Kornmann,
  • Björn Hock,
  • Harald Kolmar
Stefania Carrara
Technische Universitaet Darmstadt
Author Profile
Michael Ulitzka
Technische Universitaet Darmstadt
Author Profile
Julius Grzeschik
Ferring Darmstadt Laboratory
Author Profile
Henri Kornmann
Ferring International Center SA
Author Profile
Björn Hock
Ferring International Center SA
Author Profile
Harald Kolmar
Technische Universitaet Darmstadt
Author Profile

Abstract

Therapeutic monoclonal antibodies and related products have steadily grown to become the dominant product class within the biopharmaceutical market. Production of antibodies requires special precautions to ensure safety and efficacy of the product. In particular, minimizing antibody product heterogeneity is crucial as drug substance variants may impair the activity, efficacy, safety and pharmacokinetic properties of an antibody, consequently resulting in the failure of a product in pre-clinical and clinical development. This review will cover the manufacturing and formulation challenges and advances of therapeutic monoclonal antibodies, with a focus on improved processes to minimize variants and ensure batch-to-batch consistency. Processes put in place by regulatory agencies such as Quality-by-Design (QbD) and current Good Manufacturing Practices (cGMP) will be reviewed, and how their implementation has aided drug development in pharmaceutical companies. Advances in formulation and considerations on the intended use of a therapeutic antibody, including route of administration and patient compliance, will be discussed.

Peer review status:UNDER REVIEW

08 Jun 2020Submitted to Biotechnology and Bioengineering
09 Jun 2020Assigned to Editor
09 Jun 2020Submission Checks Completed
11 Jun 2020Reviewer(s) Assigned
20 Jun 2020Review(s) Completed, Editorial Evaluation Pending