Comprehensive Lot Release Testing
Every batch of biologic produced, whether for clinical or commercial supply, must undergo comprehensive lot release testing to maintain compliance with strict regulatory requirements for quality and safety.
This includes detailed analysis of not only the raw materials, but also the bulk harvest, the purified bulk (drug substance), and the final filled product (drug product).
Overview of the biomanufacturing process for a monoclonal antibody.
Our Services
We support lot release testing at every stage of the biomanufacturing process by providing a comprehensive spectrum of cGMP compliant services. Leveraging our world-renowned biologics expertise to ensure the quality and purity of materials used during biomanufacturing, these encompass: |
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As well as employing established approaches to lot release testing, we continually build on our reputation for trusted innovation by evaluating emerging technologies and developing new initiatives. Several of these newer methods - including techniques such as droplet digital PCR and Next Generation Sequencing (NGS) - have been incorporated into our rapid molecular testing service offering. This demonstrates just one of the many ways that we’re helping our partners to accelerate biomanufacturing timelines and maintain a competitive advantage.
Whatever stage your biologic is at, protect your investment by partnering with us for lot release testing.
Contact us for your Lot Release Testing needs
