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Live Biotherapeutic Products (LBPs), a class of medicinal products containing live microorganisms, are reshaping treatment strategies across gastrointestinal, metabolic, immunological, and neurological conditions. Due to their biological complexity and strict regulatory classification, manufacturing these therapies demands highly specialized LBP CDMO companies with deep microbiological and GMP expertise.
Partnering with a CDMO that offers robust live biotherapeutic products contract manufacturing capabilities ensures the viability, purity, and stability of your microbial therapeutic — from early-stage development through commercial production.
When selecting among LBP CDMO companies, consider these key factors:
Expertise with strict anaerobes or spore-forming strains
GMP-compliant microbial manufacturing facilities with controlled environments
In-house process development for fermentation, harvesting, and stabilization
Viability and potency preservation throughout manufacturing and packaging
Regulatory experience with LBP-specific expectations under EMA, FDA (CBER), and WHO
Sterility assurance and live cell characterization tools
Given the regulatory classification of LBPs as biologics (not probiotics), only a select group of CDMOs can meet the required quality standards.
Specialized live biotherapeutic products contract manufacturing includes:
Strain isolation, selection, and bank creation under GMP
Anaerobic and aerobic fermentation process development
Harvesting and downstream processing with viability protection
Freeze-drying (lyophilization) or encapsulation for oral delivery
Formulation and fill-finish in capsules, sachets, or liquids
Microbiological and analytical testing: CFU counts, ID testing, endotoxin, moisture
Stability testing under ICH conditions
Regulatory support tailored to LBP submissions
These services ensure your product’s safety, consistency, and therapeutic potential.
Working with experienced LBP CDMO companies offers distinct advantages:
Biological viability focus: Processes designed to maintain potency throughout production and shelf life
Customized infrastructure: Anaerobic chambers, low-oxygen filling, and controlled storage
Integrated regulatory and scientific expertise: Support for FDA INDs and EMA ATMP classifications
End-to-end development: From strain selection to final dosage form
Accelerated timelines: Using established microbial platforms and experience with clinical LBP programs
These CDMOs enable you to develop and launch microbiome-based therapies efficiently and compliantly.
Some of the top LBP CDMO companies include:
53Biologics: CDMO specialized in decoding biologics production, from DNA to proteins, providing from preclinical to cGMP manufacturing. [See CDMO profile]
BDI biotech: CDMO works as an R&D department specialized in strain and bioprocess development, scale-up and batches production. [See CDMO profile]
At MAI CDMO, we specialize in connecting you with expert LBP CDMO companies that meet the demanding quality, viability, and regulatory needs of microbiome-based therapies. Whether you´re advancing a Phase I program or launching a commercial LBP, we can help you find the best live biotherapeutic products contract manufacturing partner.
Ready to move your LBP forward? Contact us today and find the right CDMO for your strain, delivery system, and clinical strategy.
If you have any questions or suggestions, click here. We will be happy to assist you.