Fully Integrated
End-to-End Service

Phase III & Commercial Manufacturing

Fully Integrated
End-to-End Service

Phase III & Commercial Manufacturing

Phase III & Commercial Manufacturing

Our built-for-purpose Phase III commercial facility is planned to be online in 2024 and will offer high-quality cGMP commercial manufacturing. The facility will manufacture the following therapeutics and products:

Phase III – Commercial
Live Biotherapeutic Products (LBPs)
Phase III – Commercial
Bacterial Expressed Recombinant Proteins
Phase III – Commercial
Bacterial Derived Products

Once your product is ready for late-stage manufacturing, our new facility will be available to take your project through Phase III to commercial manufacturing as part of our fully-integrated, end-to-end CDMO service offering.

In these later phases of manufacturing, List Labs will work to optimize:

Speed to Market Encapsulation Rate
Efficacy Product Quality

List Labs’ Commercial
Facility

Our new facility will focus on the Phase III manufacturing of biotherapeutics, extending our full-service biotherapeutics production abilities into high-quality cGMP-compliant commercial manufacturing.

The new, facility will feature the following equipment:

Phase III – Commercial
2X 1000L Single Use Bioreactors
Phase III – Commercial
1000L Capacity Tangential Flow Filtration
Phase III – Commercial
Lyophilization
Phase III – Commercial

Analytical Testing

The new facility will also feature extensive testing capabilities, supporting process development and accelerating your project timeline.

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 live biotherapeutic products (LBPs), List Labs performs the following assays:

Viability assays by colony forming units (CFU) or live/dead staining
Identification Total cell counts
Moisture Bioactivity assays
Bioburden using USP<61> and UPS<62>
Endotoxin Appearance