List Labs offers a variety of services to pharmaceutical, biotechnology, start-ups, and government organizations ranging from technology transfer to process development and scale up to cGMP manufacturing for Phase 1 and 2 clinical supply. We have GMP capabilities to manufacture bacterial products and proteins from our catalog or through custom offerings. In addition, List Labs has a wealth of experience in cGMP manufacturing of Live Biotherapeutic Products (LBP).
List Labs can perform both in process, QC analytical assays, and release testing for products. For Live Biotherapeutic Products, List Labs performs viability assays by colony forming units (CFU) or live/dead staining, identification, total cell counts, moisture, bioburden using USP<61> and UPS<62>, and bioactivity assays. We also have a number of analytical techniques to characterize protein and toxin products including native and SDS-PAGE, Western Blot analysis, protein concentration, endotoxin, KDO and phosphate analysis, ELISA, HPLC, thin layer chromatography, cell cytotoxicity assays, cytokine assays, fluorescent and colorimetric enzyme assays.
Through contract services, we offer a highly sensitive assay to detect low levels of botulinum neurotoxin type A (BoNT/A) in complex matrices and diluted plasma. We also have a sensitive and specific assay for detection of anthrax lethal factor (LF) in plasma.
For further information on QC analytical capabilities, see the following link: [link]
Once we have a purchase order and deposit, List can usually schedule work to begin within 12-16 weeks.
Up to BSL 3.
Yes, custom runs can be arranged. You would need to take the yield from the full run.
Yes, we have strains and we can discuss opportunities with you.
We have small 1 liter scale, stainless steel reactors capable of 100 liters. We may also expand compacity using disposables.
Yes, see this link for a description of our development capabilities: [link]
Yes, List Labs has extensive experience producing live biotherapeutic products (LBP) for clinical trials.
Yes, we have the capabilities and manufacturing controls in place to work with spores. List Labs is one of only a handful or CMOs that have the capabilities to work with spore forming organisms.
Yes, we have a wealth of experience and expertise in handling and growth strict anaerobic organisms.
List Labs can lyophilize 3000 2mL vials or 7.5L of bulk material in each of our 3 lyophilizers.
Yes, List Labs has produced GMP products for both Phase 1 and Phase 2 clinical trials.
Yes, List Labs can perform stability testing for your products.
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