Live Biotherapeutic Products| List Labs

Live Biotherapeutic Products

List Labs is one of the leading CDMOs providing live biotherapeutic products (LBPs), supporting innovators developing microbiome-based therapeutics.

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Live Biotherapeutic Products

LBPs and the Human Microbiome

The human microbiome – the complex community of microorganisms that populate the gut and other areas of the body, as well as living on the skin – has been shown to have a strong relationship and positive impact on immunity against disease and health in general.

LBPs and the Human Microbiome

The reintroduction of beneficial microorganisms using LBPs has the potential to behave as clinically relevant therapy to re-establish and maintain a healthy microbiome. Individual bacterial strains and large consortia of bacteria are currently being studied as potential agents for treating disease via this mechanism.

LBPs and the Human Microbiome

List Labs is one of the most experienced CDMOs in the field of LBPs, having produced some of the earliest products for clinical trials. We have worked on many microbiome projects using gut, skin, and vaginal bacteria, developing scalable processes under cGMP to produce LBPs with both aerobic and anaerobic microorganisms.

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сGMP Drug Substance

Aerobic Organisms

Anaerobic Organisms

Spores & Spore Formers

Single Strains & Multi-Strain Consortia

Process Development

Liquid & Lyophilized Drug Product

QC / Analytical Testing

Learn more about Our LBP Experience

Bacterial Strains

Bacterial strains we have worked with.

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LBP Manufacturing Equipment

List Labs Equipment List

Results that build trust and engagement

LBP Process Development

Process Development

With a long legacy of manufacturing know-how in bacterial products and a wealth of expertise in live biotherapeutic products (LBPs) in-house, List Labs is well positioned to provide the development experience necessary to establish a robust and reproducible process for your products, laying the crucial foundation for long-term success.

Process Development

An initial tech transfer gives us familiarity with the bacterial strain and process, and we aim to replicate your data and results. Small scale work is then designed to support a seamless transition to a process that is geared towards large-scale cGMP manufacturing. Through optimization of media and fermentation conditions, we are typically able to increase product yield. Additionally, animal-derived components are replaced with non-animal origin (NAO) components in preparation for cGMP manufacturing.

Process Development

In order to establish a proper design space for the manufacturing process, various scalable fermentation process parameters can be evaluated in parallel:

Media Fomulations PH Control

DO Control Agitation Speed

Gas Sparging Incubation Temperature

Fed-batch Parameters

Process Development

To support process development and validation, we recommend that clients provide in-process tests to help with evaluation of each step. We use test methods for a variety of assays, from Colony Forming Unit (CFU) determinations to measuring the bioactivity of the organism or the compounds it produces. Harvest development entails optimization of the hollow fiber membrane surface area, flow rate, and pore size to concentrate the bacterial cells and remove fermentation byproducts. This process presents a significant challenge for strict anaerobes which are expected to be viable after processing. List Labs has developed proprietary methods with anaerobes to recover cells while maintaining an anoxic environment to ensure minimal loss.

Process Development

In order to preserve the harvested bacteria, lyophilization is typically preferred — and we have successfully preserved bacterial cultures for more than 45 years with this method. When bacteria are used as therapeutics, it is necessary to maintain a high density of viable organisms that are stable over a reasonable product lifetime. The concentrated bacteria are suspended in a compatible solution that will include a cGMP compliant cryoprotectant. Several formulations can be tested simultaneously, enabling rapid process development.

To ensure success, we tailor analytical method development to your specific LBP. Tests may include moisture, water activity, pH, osmolality, endotoxin content, viability, bioburden, and bioactivity.

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Cell Bank Preservation

Inoculum/Seed Optimization

Media Optimization

Formulation

Fermentation

Harvesting

Lyophilization

Analytical Method

Process Scale-Up

The highly skilled team at List Labs has extensive experience with cGMP manufacturing

cGMP Manufacturing of LBP Products

The highly skilled team at List Labs has extensive experience with cGMP manufacturing of LBP products from a broad range of genera, including strict anaerobe species. Our purpose-designed manufacturing facility provides segregation and containment in seven ISO7 or ISO8 manufacturing suites. We have multiple suites that enable parallel cGMP manufacturing activities, streamlining project timelines and avoiding delays.

We offer state-of-the-art cultivation of strict anaerobes for Research Cell Bank or Master Cell Bank production in an internal HEPA filtered anaerobe chamber to maintain an aseptic process not possible in typical anaerobe chambers.

cGMP Services

cGMP Master and Working Cell Bank Production

cGMP Drug Substance Production

cGMP Drug Product Production

Fermentation and Harvesting

Sieving and Dry Filling

Formulation and Lyophilization

Liquid Filling

Research Cell Bank Production

Custom Packaging

cGMP Highlights

Large-scale options for cultivation and fermentation, including 500L single-use bioreactor, 100L stainless steel vessel with validated cleaning procedures and 40L single-use bioreactors

Closed system to harvest the microorganism by tangential flow filtration using a hollow fiber or filter stacks prior to formulation and lyophilization

Three lyophilizers with a 5 bulk 1.5L tray capacity or 3,000 x 2mL vials

Sieving and powder filling into various packaging formats (vials, sachets, capsules, applicators, etc)