List Labs offers a variety of custom services. We are highly experienced in the production of hard to grow bacteria and the development of strains for optimized growth. In addition, we have expertise with aerobes, anaerobes, and spore formers. We are BSL1 to BSL3 capable and are approved for working with Select Agents and Toxins. If you have a candidate strain that requires development contact us to learn more about what we can do to advance your work. We also manufacture nearly 100 reagent grade bacterial products and can produce GMP versions or provide custom or bulk fills.
Custom Product Fills
Whether you want one of our standard products in quantity in another size fill, or you need manufacturing and a custom fill of your own product, we are able to provide these services at reagent or GMP grade. Custom fills require a minimum quantity commitment and may take several months to schedule.
Custom Batches of
Do you need a product we don’t make? Ask us about developing a custom batch for you. Need something in a different size or made a different way, we can do that as well. Custom batches will require minimum quantity commitments and take several months to produce.
List Labs staff has over 25 years’ experience manufacturing bacterial based novel drug substances and products. List maintains several Drug Master Files with FDA and Health Canada and provides support to clients for IND filings. As required by the State of California, List Labs maintains a current Drug Manufacturing License and CDC Select Agent registration enabling us to produce drug substance and drug products for our clients.
List Labs has manufactured a variety of bacterial toxins and proteins, live biotherapeutics products (LBS), and polysaccharides for our clients. cGMP manufacturing has included both drug substance and drug products for Phase I and II clinical trials.
List complies with 21 CFR 210, 211, as well as ICH and Regulatory Guidelines, as applicable, for early stage Investigational New Drugs (IND) and Investigational Medicinal Products (IMP).
For more information, see our GMP services page.