Biologics QC Lot Release Support
Do you have questions about bioassay selection, optimization, qualification or validation for your biologics drug candidate? Promega supports customers through the various stages of drug development in a many ways, including:
- Product quality documentation
- Business support to enable global CROs
- Scientific and technical support
Product Documentation Supporting QC Lot Release
Promega bioassays are used globally in the development and commercialization of on-market biologics drugs. Our assays are manufactured under a robust and mature quality system, and we are able to provide the necessary documentation to support regulatory filings, including:
- Certificates of Analysis
- Traceable Product Batch Records
- Stability Data
- Product Change Control and Notification Procedures.
Business Support for Outsourcing Bioassays to CROs
Outsourcing of biologics testing to contract research organizations (CROs) is a growing trend in the biopharmaceutical industry. We support global CROs who offer bioassay services as well as researchers who want to transfer their bioassay to one or more CROs.
Contact us for more information, or to obtain a list of CROs with experience running our assays.
include Promega assays in their services.
Scientific and Technical Support
Promega Technical Services Scientists are available to support you and answer your questions about available products, services and scientific support. Contact us to discuss your biologics research and assay development needs.
Manufacturing and Quality Systems
Promega functional bioassays and protein characterization products are manufactured in our global state-of-the-art facilities. Over 450,000 square feet of environmentally controlled manufacturing spaces allow flexible bulk manufacture with capabilities for custom automated or semi-automated filling and packaging. We are prepared to accommodate your needs; from bulk production through final product finishing.