The manufacture of cGMP-grade biologics demands that production processes, product characteristics, and product analytical test methods be well defined to ensure that the product is safe, effective, and consistent between manufactured batches. These activities, known as CMC (chemistry, manufacturing, and controls) are required by global regulatory agencies throughout product development. The analytical testing package supporting CMC has elements requiring comprehensive capabilities and specialized expertise, operating within a cGMP-compliant quality management system.
The experts at Scorpion not only understand the process from the initial research stage through to cGMP manufacturing, but are knowledgeable in global regulatory guidance and requirements, as well as the utilization of “phase-appropriate” cGMP compliance methodologies. The FDA and other global regulatory agencies collectively support regulatory flexibility for early-phase manufacturing and testing of advanced therapies, including cell and gene therapies, protein therapeutics and vaccines. A phase-appropriate approach reduces the cGMP compliance burden during clinical development and facilitates a faster route to early-phase clinical studies.
Scorpion offers CMC analytical testing support for both cGMP product release testing, as well as product stability programs conducted under cGMP and ICH guidelines.