Reagent Grade and GMP Bacterial Toxins

Bacterial Toxins

List Labs has extensive experience manufacturing custom Reagent Grade and GMP bacterial toxin products for both Phase I and Phase II clinical trials.

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Bacterial Toxins

Use of Bacterial Toxins

Bacterial toxins have been used in a wide range of applications based on their unique properties. Cholera toxin B subunit and a pertussis toxin mutant can be used as vaccine carrier proteins or adjuvants to promote stronger immune responses to target polysaccharides or peptides in order to improve vaccine efficacy. More notably, botulinum neurotoxins have been extensively used in clinical studies for many different benefits from cosmetic to treating hyperhidrosis or migraines.

Toxins we have worked with

Use of Bacterial Toxins

List Labs has two decades of experience developing scalable purification processes to produce GMP compliant bacterial products. We have a portfolio of bacterial toxin products, and all can be manufactured under GMP. List Labs can also develop purification plans for any bacterial protein

Our Portfolio Of Products

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Results that build trust and engagement

Process Development

Process Development

With over four decades of experience, List Labs has the expertise to meet the unique needs of your bacterial toxin projects. Following an initial tech transfer — to acquire familiarity with the protein and process and replicate client data and results — small scale work is designed to support a seamless transition to a process that will support large-scale cGMP manufacturing.

Process Development

In-process tests support process development and future process validation, which provide relevant information and aids in the evaluation of the success of each step. Test methods for a variety of evaluations are currently in use, from activity testing to immunoassays to ensure efficacy and confirm the quantity of the target protein.

Process Development

To ensure success, we tailor analytical method development to your specific project. For bacterial toxin projects, these tests may include moisture, water activity, pH, osmolality, endotoxin content, and specific activity of the target protein.

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Media Optimization

Fermentation

Purification

Lyophilization

Analytical Method

Process Scale Up

cGMP Manufacturing

cGMP Manufacturing

List Labs’ highly skilled team has a wealth of experience with cGMP manufacturing of recombinant protein products from E. coli, B. subtilis and many other strains . Our expertly designed manufacturing facility provides containment in ISO7 or ISO8 suites, and multiple production suites allowing parallel cGMP manufacturing activities to streamline project timelines.

cGMP Manufacturing

List Labs has several large-scale options for the production of recombinant proteins including 100L stainless steel vessels with validated cleaning procedures, and a 500L Single Use bioreactor. ‌

Downstream production capabilities include:

Tangential Flow Filtration units

Three ÄKTA FPLCs for the purification of recombinant proteins

Three lyophilizers with a 5 x 1.5L bulk tray, or 3000 x 2 mL vials, capacity each

Sieving and powder filling into different packaging modalities upon client request