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Introduction

List Biological Laboratories, Inc. (List Labs) is an American Biotechnology company known as one of the worldwide leaders in producing bacterial toxins[1]. Their products support vaccine development, toxin research and infectious disease research worldwide[2]. List Labs also offer services supporting the Live Biotherapeutics product field, working with anaerobic, aerobic, and spore forming organisms[3]. They are registered with the Federal Select Agent and Toxin Program and can operate up to Biosafety Level (BSL) 3[4]. Their facility is designed and operated in compliance with cGMP's for phase 1 and 2[5]. In addition to manufacturing, they also have analytical testing capabilities.

The company was established in 1978 and is headquartered in Campbell, CA[6].

Business Segments

Bacterial Products

List Labs' core business is bacterial toxins, and they leverage their expertise in growing fastidious bacteria into a service business as well[7]. Customers request GMP versions of their products and custom orders of other products for clinical trials[8]. They specialize in up to 100-liter fermentation's[9]. The total product catalog has over 100 products representing a variety of bacterial reagents, toxins, polysaccharides, peptides, antisera and antibodies[10]. List Labs also manufactures GMP products for sale, including a Lipopolysaccharide (LPS) used presently in multiple clinical trials[11].

Manufacturing Services

List Biological Laboratories provide support for development and manufacturing of microorganisms as Live Biotherapeutic Products (LBP), as well as for microbial proteins and microbial cell components (LPS or polysaccharides for drug development[12].

Such services include:

  • GMP Contract Manufacturing[13]
  • Live Biotherapeutic Products[14]
  • Cell Banking[15]
  • Analytical[5]
  • Assay Development & Qualification[16]
  • Process Development (Fermentation, purification and lyophilization)[17]

Milestones

  • Cholera toxin was sought after by those doing research in signal transduction and by others using the toxin B subunit to label neurons.[18]
  • Performed tech transfer of Botulinum toxin manufacturing process to Allergan (for the product now known as Botox)[19]
  • Manufactured GMP LPS, first human grade LPS product for clinical trial use.
  • Manufactured one of the first live biotherapeutic products

Trademarks and Patents

  • SNAPtide product #520 (U.S. Patent #6,504,006)
  • MAPKKide product #530
  • VAMPtide product #540
  • SNAPEtide product #550
  • SYNTAXtide product #560
  • HPT product #433
  • GST-SV2c luminal domain (U.S. Patent #8,476,024)
  • Substrate Peptides and Assays for Detecting and Measuring Proteolytic Activity of Serotype A Neurotoxin from Clostridium Botulinum (U.S. Patent #9932570 - MAPkkide plus)

External Links

  • Official website
  • List Labs Citations
  • About List Labs
  • List Labs Crunch Base Profile
  • List Labs Glassdoor Profile
  • List Labs Bloomberg business profile
  • List Labs Hoover business profile
  • ASM Marketing Page
  • ResearchGate

Recent Press release

List Labs Announces New Anthrax Lethal Factor Detection Method

References

  1. ^ "List Labs Introduction". Cedarlane.
  2. ^ "Vaccine Development for the Control of Bordetella Pertussis Infections (Whooping Cough)". List Biological Laboratories, Inc.
  3. ^ "Microbiome and Live Biotherapeutic Expertise". Youtube.com.
  4. ^ "Federal Select Agent Program". SelectAgents.gov.
  5. ^ a b "Compliance with cGMP for Phase 1 and 2". listlabs.com.
  6. ^ "Bloomberg Business". Bloomberg.com.
  7. ^ "Bacterial Toxins". Listlabs.com.
  8. ^ "GMP Products". listlabs.com.
  9. ^ "100-liter fermentation". listlabs.com.
  10. ^ "Over 100 products". listlabs.com.
  11. ^ "GMP LPS". SagePub.
  12. ^ "Development of Live Biotherapeutic Products". YouTube.com.
  13. ^ "GMP Contract Manufacturing". listlabs.com.
  14. ^ "Live Biotherapeutic Products". listlabs.com.
  15. ^ "Cell Banking". Science Exchange.
  16. ^ "Assay Development and Qualification". CrunchBase.
  17. ^ "Process Development". ScienceExchange.
  18. ^ "Cholera Toxin". listlabs.com.
  19. ^ "Tech transfer to Allergan". listlabs.com.