GMP Lab in Middleton, Wisconsin
Comprehensive solutions for drug product development
Our leading-edge GMP lab facility provides high-quality analytical services for small molecules and biologics including APIs, drug products, inhaled products and other medical devices – for all phases of drug development.
Watch the video to see how:
- our experienced teams develop and validate customized methods
- we support CDMO sites for drug substances and drug products
- our CMC services can streamline assay validations and save time
From structural analysis and stability testing, to extractables and leachables and biosafety testing, you’ll find everything you need to document the quality of your product.
Device and small molecule testing services
Our leading-edge facility provides a suite of device and small molecule testing services. In our device testing labs, testing for drug-device combination products including parenteral and inhalation devices involving:
- physical testing to document the performance of the device
- container-closure integrity testing (CCIT) to ensure sterility is maintained.
We provide advanced extractable and leachable (E&L) testing to achieve sensitivity levels and identification capabilities that often exceed regulatory expectations:
- comprehensive elemental impurity testing using inductively coupled plasma
- leachables labs provide comprehensive services.
By providing all aspects of drug substance and drug product method development, validation, and routine testing for release and manufacturing support, we can help shorten development timelines and reduce costs.
Biologics, cell and gene therapies and biosafety testing services
Take a tour of our flagship laboratory in Wisconsin to learn about our suite of biologics, cell and gene therapies and biosafety testing services. Our large molecule services include product testing for monoclonal antibodies, oligos, antibody drug conjugates and other conjugated products, cell and gene therapies, including CRISPR and mRNA products.
- We can support full test panels for cell and gene therapy products including viral vectors, mRNAs, lipid nanoparticles, human genome editing products and more.
- PCR and molecular biology are a key part of testing for cell and gene therapies and we have a large team to support complex and novel assays, including next-generation sequencing. We also have numerous bioassay labs dedicated to cell gene therapy and other biologic products.
- We provide mycoplasma and viral testing services to support the development of biologics and cell and gene therapies.
Learn about our resources and expertise to support analytics for a broad range of product types from early phase through commercial support.