Unleashing the Power of the Microbiome: Advancements, Challenges, and the Therapeutic Future

April 4, 2023PAO-03-23-CL-08

The human microbiome has been shown to play extensive roles in health and disease. Many new therapeutics are being developed to leverage the microbiome to treat a wide range of diseases. This innovation is burdened by the host of manufacturing, regulatory, and other challenges facing drug developers. Contract development and manufacturing organizations (CDMOs) with experience in the production of microbes as therapeutics will play a key role in enabling realization of the full potential of this emerging field. List Labs, with decades of experience and the ability to provide end-to-end support at clinical and commercial scale, is positioned to be a leading outsourcing partner for developers of microbiome-based live biotherapeutic products (LBPs) and other live bacterial therapeutics.

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List Labs Advances Live Biotherapeutics and Biologics Manufacturing with Increased Capacity

CAMPBELL, Calif., Jan. 24, 2023 /PRNewswire/ — List Labs, a live biotherapeutics-focused contract development manufacturing organization (CDMO), adds 500L equipment to expand its bacterial manufacturing capacity.

Based on the increased demand for larger volume manufacturing, List Labs recently added single-use equipment, including a Sartorius 500L Stedim bioreactor and a Cytiva ÄKTA Readyflux XL tangential flow filtration system to their California GMP drug manufacturing facility. The expansion, available now to customers, will significantly increase List Labs’ unique capabilities in bacterial therapeutic manufacturing capacity appropriate for Phase 1 and 2 clinical trials.

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List Labs and List Bio For A Healthier World

Uddin, Rash. “For A Healthier World.” “Business Focus Magazine” Issue # 104, November 30th, 2022, page 90.

A recognized expert in this field is California-based List Biological Laboratories, Inc. (List Labs), a microbiome contract development and manufacturing organization (CDMO) with a proven track record over several decades. Last year, List Labs was acquired by Genome & Company, a South Korean developer of innovative drugs and novel target immune checkpoint inhibitors.

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List Biotherapeutics Establishes New Microbiome Manufacturing Facility in Fishers

FISHERS, Ind.–(BUSINESS WIRE)–List Biotherapeutics, Inc. (List Bio), whose parent company is South Korea-based Genome & Company (KOSDAQ: 314130), today announced a more than $125 million investment in the city of Fishers to establish a new 110,000 square foot contract manufacturing organization (CMO) facility on 15 acres in the Fishers Life Science & Innovation Park. The company plans to hire 210 employees in Fishers in the areas of biologics manufacturing and quality and regulatory compliance after commissioning the facility by the end of 2023, which includes a new lab and office space in Fishers.

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Microbiome CDMO, List Labs, Partners with Genome And Company, to Create Global Microbiome Research, Development, and Manufacturing Powerhouse

CAMPBELL, Calif.Sept. 21, 2021 /PRNewswire/ — In an unprecedented collaboration, premier microbiome CDMO List Labs partners with leading global clinical stage biotechnology company, Genome and Company (KRX: 314130). Republic of South Korea based Genome and Company has entered into agreements subject to regulatory approval to acquire controlling interest in U.S. based List Biological Laboratories, Inc. (List Labs). The resulting partnership creates the first global Live Biotherapeutic Drug Development company with integrated Contract Development and Manufacturing capabilities.

The partnership will allow List Labs to attain its strategic vision to expand and build additional capacity and accelerate the realization of an end-to-end solution for all phases of clinical trial material and commercial production. List Labs will maintain independent operational control of all client activities, ensuring the confidentiality of contract client’s proprietary information. This will allow List Labs to generate revenue by continuing to provide world class CDMO services to the open market. In addition, List Labs will continue to serve an impressive global customer base with high-quality bacterial products, including toxins and cGMP LPS, a legacy established in 1978.

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BetterLife Scales up Manufacturing of AP-003 (Interferon Alpha 2b) to Prepare for Clinical Trials

VANCOUVER, Sept. 17, 2020 (GLOBE NEWSWIRE) — BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAT) an emerging biotech company, today announced it has entered into an agreement with List Biological Laboratories, Inc. (“List Labs”) for the manufacture of its proprietary interferon alpha 2b for the treatment of COVID-19.

“Following our recent merger, we are proud to be continuing the development of Altum Pharmaceutical’s proprietary interferon alpha 2b inhalation for treatment of COVID-19. We look forward to working with List Labs to bring this treatment to patients as quickly as possible as we prepare for our imminent trials in Australia” said BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian.

Under the terms of the agreement, List Labs will provide manufacturing services from its state-of-the-art biological development and cGMP manufacturing facility in Campbell, California.

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List Labs Fields Upgraded Management Team

Executive Team Evolves to Maximize Strengths

CAMPBELL, Calif., Aug. 11, 2020 /PRNewswire/ — Effective June 1, 2020, List Biological Laboratories, Inc. has reorganized their management team to better apply the wide-ranging skills of their executives.

Dr. Karen Crawford moves from President to Board Chair. This will free her from day-to-day operations while still keeping her involved in the company’s strategic direction and providing her considerable technical expertise to List Labs’ work. Dr. Crawford joined List Labs in 1989 and served as President from 1999 to 2020. She led List Labs to build and commission a cGMP parenteral toxin drug manufacturing facility where she supervised production and upstream processing of a clostridial toxin. In addition, she directed the development of numerous toxin products including toxins produced by various types of Clostridium botulinum, Clostridium difficile, Bacillus anthracis, Corynebacterium diphtheriae and the CRM mutant.

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List Labs Announces New Anthrax Lethal Factor Detection Method

CAMPBELL, Calif.Dec. 13, 2018 /PRNewswire/ — Since the intentional release of anthrax spores leading to lethal inhalational anthrax in 2001, the need for rapid and sensitive detection of infection has been critical. Unfortunately, early symptoms of infection are similar to those of common illnesses. While the symptoms are not remarkable, the Bacillus anthracis bacteria enter the patient’s bloodstream and rapidly multiply. This expanding population of bacteria produces deadly proteins that will eventually overcome the patient. Classical techniques to detect and identify bacteria in blood take too long. We have devised a rapid method for detecting one of the proteins produced in the infection. This protein, anthrax lethal factor, is produced early in infection in a quantity sufficient for detection making it possible to rapidly determine that a patient is infected and to initiate therapy. A quick diagnosis is essential for the successful treatment of the disease.

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