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cGMP Manufacturing Phase 1, 2, 3 & Commercial

CDMO Services: Greater Capacity and End-to-End LBP Manufacturing

September 19, 2022

By: List Labs

List Labs is an experienced contract development and manufacturing organization (CDMO) harnessing bacteria’s potential for a healthier world. We offer a refreshingly flexible approach to clients seeking a CDMO for Live Biotherapeutic Products (LBP) derived from beneficial bacteria. Partner with List Labs as your CDMO and experience our uniquely collaborative and transparent culture. With over 40 years of experience, our expertise encompasses aerobes, anaerobes, and spore formers, process development and scale up, analytical development and QC testing, aseptic filling, purification, lyophilization, and cGMP manufacturing for clinical trials and future commercial launch. List Labs produced the first LBP for clinical trial before LBP was even an acronym, followed by dozens of products that led to successful clinical LBP programs. List Labs provides a solid foundation in science, purpose-built state-of-the-art facilities, and a passionate team to ensure the success of your LBP project.

New CDMO Services Trade Show Exhibit booth and Trade Show Updates

In June, we unveiled our new services trade show exhibit at the Microbiome Movement Drug Development Summit 2022. This new trade show exhibit highlights our expanded service offerings and experience in this field.

cGMP Manufacturing Phase 1, 2, 3 & Commercial

Breakdown of our new services trade show exhibit

Our company mission statement:

Harnessing Bacteria’s Potential for a Healthier World

Expanded Services:

cGMP Manufacturing Phase 1, 2, 3 & Commercial

  • Live Biotherapeutics
  • Bacterial Products
  • MCB & WCB
  • Drug Substance
  • Drug Products
  • Process Development
  • 1L to 2000L
  • QC Testing
  • Analytical Development
  • Stability
  • Aerobes
  • Anaerobes
  • Spores
  • BSL1-3

Along with Fermentation, Purification, Fill, and Lyophilization services.

We then highlight our experience and the life of our company by sharing the year (1978) we started List Labs.

Next year at the Microbiome Movement Drug Development Summit 2023, we’ll upgrade our exhibitor package and extend our presentation time to introduce List’s expansion and the addition of late phase and commercial manufacturing capacity.

Previous Microbiome Movement Presentations:

Leveraging Experience and Process Flexibility to Support the Development & Manufacturing of Novel Microbiome Therapeutic Products from Clinic to Commercial Launch

(Microbiome Movement Drug Development Summit 2021)

Overcoming Obstacles in the development of Live Biotherapeutic Products

(Microbiome Movement Drug Development Summit 2020)

Trade Shows, we will be attending this year (2022):

Platinum Sponsor of the Microbiome Connect USA 2022: Boston, USA 16-17 November 2022
contact us if you’d like to schedule a meeting at the conference!

See our conferences page for other upcoming events.

New Equipment, Greater Capacity!

We recently purchased and installed our Sartorius 500L Stedim bioreactor and already have client projects booked and scheduled. Please contact us to discuss scheduling your project! Our new 500L SUB provides the capacity your project need as you progress toward late phase and commercialization.

New supporting equipment has also been purchased and installed. The AKTA filtration system  will support the significant increase in scale while maintaining the high quality and purity our customers expect.

Our vision is to take our partners from pre-clinical and early phase trials to the commercialization of their products. This new equipment is helping that vision become a reality!

End-to-End LBP Manufacturing Services

Now that we have started the development of our manufacturing facility in Fishers, Indiana, we are close to genuinely becoming an end-to-end LPB Manufacturing organization, offering early-stage development, Phase I, II, III, and Commercial Manufacturing.

List Labs manufacturing facilities:

List Labs Campbell, CA (Phase 1 & 2)

  • 26,921 ft Facility
  • Phase 1 and 2 Manufacturing
  • 2x 100L SS, 500L SUB
  • cGMP Compliance
  • 7 Manufacturing Suites
  • Segregation of Product Campaigns
  • VHP Sanitization
  • Spore Containment

List Labs Fishers, In (Phase 3 & Commercial)

  • 130,000 ft Facility
  • Phase 3 and Commercial Manufacturing
  • 2000L, SS, and SUB
  • US FDA and EMA Compliance
  • Customizable Solutions
  • Build to Suite Opportunities
  • Now Booking for 2024!

CDMO Services

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Learn more about our CDMO Services.

Contact us if you have any questions or would like to partner on your next project!

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