cGMP Manufacturing Process Development

Process Development
for cGMP Manufacturing

Reproducible and streamlined, our process development services accelerate timelines and keep your projects on track.

Along with an initial tech transfer — to acquire familiarity with the bacterial strain, protein, or process and replicate client data and results — small-scale work is designed to support process for large-scale cGMP manufacturing, and seamless transition that advances your project rapidly.

cGMP Manufacturing Services

As an Industry-Leading CDMO, We Advance Process Development for LBPs

With over a decade of experience manufacturing live biotherapeutic products, List Labs has the expertise and know how to develop a scalable and GMP compliant manufacturing process.

From development of a process for a single strain to a consortia, List Labs’ expertise includes aerobes, strict and obligate anaerobes, and spore forming microorganisms. Pure bacterial cultures are grown and harvested under aseptic and controlled conditions, and the bacterial cells are freeze-dried for storage to maintain viability. Optimization of media, fermentation conditions, harvest time, and lyophilization formulation frequently lead to increased yields. In addition, animal-derived components are replaced with non-animal origin (NAO) components in preparation for cGMP manufacturing.

AVAILABLE PROCESS PARAMETERS FOR LBPS

Various fermentation process parameters can be evaluated in parallel in a scalable model to establish a proper design for the manufacturing process, including:

Media Formulations pH Control DO Control

Agitation Speed Gas Sparging Incubation Temperature

Fed-batch Parameters

Process Development for Bacterial Toxins

As an industry-leading CDMO for bacterial derived toxins, we have decades of experience manufacturing products for both Phase I and Phase II clinical trials, as well as producing custom GMP bacterial products for our clients.

Optimization of liquid chromatography conditions frequently guarantees an increased yield and purity of the product. Test methods for a variety of evaluations are currently in use, from activity testing to immunoassays to ensure efficacy and confirm the quantity of the target protein.

Process Development for Recombinant Proteins

We have manufactured recombinant proteins of bacterial or mammalian origin to support our clients’ projects from R&D through Phase I and Phase II clinical trials.

Optimization of media and fermentation conditions is designed to increase the yield of product and to replace any animal-derived components with NAO raw materials for cGMP manufacturing.

Various fermentation and fed-batch fermentation process parameters can be evaluated in parallel in a scalable model to quickly establish a reliable growth process. Purification processes are similarly evaluated in parallel to meet your project goals in a timely manner.

Analytical Development

Analytical method development is vital to the success of your project, and List Labs has the depth of experience and expertise to develop and customize the necessary suitability tests for your project.

Available Analytical Method Development Tests

These tests may include:

Product Activity Antigenicity Viability

Bioburden Bioactivity Moisture

Water Activity pH Osmolality

Endotoxin Content Specific Activity of the Target Protein

Process Development
for cGMP Manufacturing

List Labs’ scalable and robust development services include:

cGMP Manufacturing Services

As an Industry-Leading CDMO, We Advance Process Development for LBPs

Process Development for Bacterial Toxins

Process Development for Recombinant Proteins

Analytical Development

Equipment

QC Analytical Testing

Questions?

Process Development for cGMP Manufacturing

List Labs’ scalable and robust development services include:

cGMP Manufacturing Services

As an Industry-Leading CDMO, We Advance Process Development for LBPs

Process Development for Bacterial Toxins

Process Development for Recombinant Proteins

Analytical Development

Equipment

QC Analytical Testing

Questions?

Process Development
for cGMP Manufacturing