Skip to the main content.

ON-DEMAND WEBINAR: Clinical Manufacturing & Development of Biologics

By some estimates, the pre-approval cost of drug development is a staggering $2.5 billion per drug and takes an average of ten years from discovery to reach market. For novel therapeutics, the highest risk is during clinical trial manufacturing development, and biologics are no different. However, biologics drug product manufacturers face some unique challenges because they are made from biological sources. Some of these challenges are batch-to-batch consistency, changing impurity profiles, and molecular instability.

Join us for a webinar to discuss:

  • Early phase development of biologics formulation
  • Biologics analytical development
  • Manufacturing process development designed to minimize the risk of delays from Concept to Clinic®

A Q & A session led by our panel of biologics experts will follow at the conclusion of the presentation.

Download On-Demand Webinar Here

1 min read

ON-DEMAND WEBINAR: Extractables & Leachables

Requirements from regulatory agencies have become increasingly rigorous with regards to the detection, identification, and quantitation of...

Read More

3 min read

Part One: Biologics and the Problem with Residual DNA

Part One: Biologics and the Problem with Residual DNA

Read More

2 min read

Part Two: Cell-Based Bioassays

Part Two: Cell-Based Bioassays

Read More