Product Characterization Assay Package - Lot Release And Stability Testing
Source: MilliporeSigma
Before your mAb therapy reaches a patient, it is important to ensure product safety and efficacy. This includes understanding the effects of environmental conditions—temperature, humidity, light, container interactions—on your mAb. We offer a full portfolio of lot release and stability testing services performed to GMP guidelines. While others may provide data points, we combine full data with regulatory guidance required for clinical submission.
Assays are available to suit your development phase, including:
- Raw Materials
- Unprocessed Bulk
- Purified Bulk (Drug Substance)
- Final Product (Drug Product)
access the Datasheet!
Log In
Get unlimited access to:
Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue.
X
Enter your credentials below to log in. Not yet a member of Biosimilar Development? Subscribe today.
Subscribe to Biosimilar Development
X
Subscribe to Biosimilar Development
MilliporeSigma
This website uses cookies to ensure you get the best experience on our website. Learn more