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.
How to Choose LBP CDMO Companies
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.
Key Services Offered by Live Biotherapeutic Products Contract Manufacturers
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.
Advantages of Partnering with LBP CDMO Companies
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.
LBP CDMO Companies
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]
- CZ Vaccines: Clinical Trials Facility for investigational and medicinal products. [See CDMO profile]
- Demo facility: Tissue therapy, Cell therapy and GTMP (Gene Therapy). [See CDMO profile]
Related Information
Let MAI CDMO Network Help You Find the Right LBP CDMO Partner
At MAI CDMO Network, 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.