cGMP LPS, from Escherichia coli O113 (Special Terms Apply*)

cGMP LPS, from Escherichia coli O113 (Special Terms Apply*)

Name: cGMP LPS, from Escherichia coli O113 (Special Terms Apply*)
Brand: List Biological Laboratories, Inc.
SKU: 9433A
Availability: InStock

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Product Brand: List Biological Laboratories, Inc.

Product Code: 9433A

Description

Product Summary:

cGMP LPS, from Escherichia coli O113 (Special Terms Apply*) (9433A) is a high quality bacterial toxin for research. Manufactured by List Biological Laboratories, Inc..

For many years, List Biological Laboratories (List Labs) has manufactured various types of Lipopolysaccharides (LPS, a.k.a. endotoxin) as reagent grade material, that are for research use only. List Labs has also developed a purification method that is compliant with cGMP guidelines according to 21 CFR 211. The purification method yields a product that is sterilizable by filtration and free of protein and nucleic acids. This GMP compliant LPS drug product is available to clinical researchers with Investigational New Drug (IND) applications submitted to the Food and Drug Administration (FDA).

This product is highly purified and well characterized. It is provided as a sterile lyophilized product in 1% lactose, 0.1% PEG6000, and is currently in stock.

A Certificate of Analysis is provided at shipment that includes a GMP compliance statement, certificate of origin and BSE/TSE statement.

GMP LPS is produced compliant to US FDA Good Manufacturing Practices guidelines found in 21 CFR 211. Please consult your internal Regulatory groups prior to use in humans.

(Special Terms Apply*)

Product Specification

Product Range

Antigens, Antibodies and Toxins

Product Code

9433A

Product Name

cGMP LPS, from Escherichia coli O113 (Special Terms Apply*)

Product Category

Lipopolysaccharides (Lps) And Related Products

Product Brand

List Biological Laboratories, Inc.

Product Analyte or Application

High Quality Bacterial Toxin For Research

Product Size

1 x 1 µg

Product Storage

2°C to 8°C

Product IVD Registration Status

Research Use Only - RUO

Product Special Terms

List Term 9: Product Referral Only

Product FAQs

Why type O113?

The bacterial strain used to produce GMP LPS is E. coli O113:H10:K-. This designates the O Antigen type (O113) of the Lipopolysaccharide (LPS), the flagella antigen type (H10) and capsule negative (K-). It is the type that was used for the National Reference Endotoxin1 and for the Second International Standard for Endotoxin. The intended use of these standards is as reference calibrants for bacterial endotoxin testing, such as pyrogenicity in rabbits or limulus amoebocyte lysate (LAL) assays. LPS type O113 has the structure typical of enteric bacteria and has the pro-inflammatory activity of a TLR-4 agonist.

What is the benefit of using List Labs GMP LPS?

The cost of custom manufacturing of a GMP product is quite high when considering the small amount of LPS that is required for clinical trials. In addition, development costs for a custom product can not only be high, but also time consuming. Because List Labs has GMP LPS in stock, there is no time delay, and the cost is associated only with the needed amount of product and not the entire batch of material produced.

A Drug Master File has been submitted to FDA and has been accepted, also eliminating time delays due to regulatory issues.

How GMP LPS is being used?

This product is appropriate for researchers doing clinical work under an IND which has been, or will be, submitted to FDA prior to use in humans. US customers can request an authorizing cross reference letter to the drug master file allowing them to cite the DMF, thereby allowing for FDA review. Currently, this product is being used by major pharmaceutical companies and universities, as well as the NIH Clinical Center for human studies.

Endotoxin has been used to study a variety of conditions that can be modeled by an inflammatory challenge with endotoxin/lipopolysaccharide from E. coli type O113. Suffredini, et al, reported the effects of intravenous endotoxin and discussed its role in the study of experimental inflammation. Bridging studies evaluated the effects of LPS manufactured by List Labs, administered intravenously, and concluded that a lot produced by List Labs is safe and produced the expected acute self-limiting inflammatory responses including pro-inflammatory cytokine responses with the expected level of adverse effects.

Endotoxin is used as an inflammatory challenge to study treatment modalities for a variety of conditions that can be induced, such as depression, lung inflammation and cardio-metabolic disease. Fullerton describes the use of endotoxin by IV challenge to reproducibly model acute or chronic inflammation and to study the effects of therapeutic interventions.

By the inhalation route, LPS induces inflammation and dendritic cell maturation as a Toll-like receptor 4 (TLR4) ligand. Ex vivo preparation of experimental cancer vaccines have utilized LPS in the cocktail to mature dendritic cells

Production and Characterisation

This product is highly purified and well characterized. It is provided as a sterile lyophilized product in 1% lactose, 0.1% PEG6000, and is currently in stock.

A Certificate of Analysis is provided at shipment that includes a GMP compliance statement, certificate of origin and BSE/TSE statement.

GMP LPS is produced compliant to US FDA Good Manufacturing Practices guidelines found in 21 CFR 211. Please consult your internal Regulatory groups prior to use in humans.

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