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Fully Integrated
End-to-End Service

Phase III & Commercial Manufacturing

Let’s Advance Together

Fully Integrated
End-to-End Service

Phase III & Commercial Manufacturing

Let’s Advance Together

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

Have a specific question about your LBP project? Click below and let’s get started.

Let’s Advance together

List Labs
540 Division Street
Campbell, California

List Biotherapeutics
9800 Crosspoint BIvd Suite 2011
Indianapolis, IN 46256, USA

Listlabs
List Biotherapeutics
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