Article

Ensuring Product Quality And Safety Through Process Optimization And Characterization

By Thomas Rene Gervais, Samsung Biologics

Samsung2

Successful manufacture of biologics is driven by fast, efficient production scale-up and consistent, high product quality. A well-characterized process is essential to achieve these goals, comprising a vital aspect of the later phase of process development (moving from clinical to commercial). Process characterization is concerned with understanding how process input variables influence the end product relative to critical quality attributes (CQA), as well as ensuring manufacturing process robustness. Process characterization is critical to the commercialization of new biopharmaceuticals since it ensures not only consistent product quality and efficacy, but also patient safety.

Successful CDMOs build client confidence by demonstrating the understanding needed to develop a robust and scalable process, backed by biostatistics and quality by design (QbD), in support of cGMP manufacturing. This article examines how Samsung Biologics combines scaled-up manufacturing data with small-scale understanding to maximize clients’ production cadence.

VIEW THE ARTICLE!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Pharmaceutical Online? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: