Is your Live Biotherapeutic Product (LBP) struggling to achieve viable yield or reliable scalability? Don't let fermentation bottlenecks stall your clinical timeline. Our specialized Microbial Fermentation Services are purpose-built for the unique demands of LBPs, featuring deep expertise in handling complex anaerobic strains and optimizing processes. Creative Biolabs provides the proven development path to ensure your novel therapeutic moves rapidly and reliably from discovery to commercial scale.
Overview
Live Biotherapeutic Products (LBPs) are the future of medicine, utilizing live microorganisms (bacteria, yeast, or consortia) to prevent, treat, or cure human diseases. Developing an LBP requires a highly specialized and robust manufacturing process centered on microbial fermentation. Our service is designed to de-risk your drug development program by optimizing the critical path from lab-scale strain to a ready drug substance.
Creative Biolabs offers end-to-end Microbial Fermentation Services-from strain acquisition and parameter optimization to pilot-scale manufacturing and downstream processing. Our expertise spans diverse microbial types and strict regulatory requirements, ensuring high biomass yield, product quality, and scalable processes critical for preclinical and early-stage clinical applications. We deliver robust, cost-effective solutions tailored to balance optimal biomass production with the stable expression of engineered therapeutic circuits.
Detailed Scope of Services
Our comprehensive LBP fermentation service covers all stages of upstream and downstream processing.
Workflow
Service Details
Samples
Deliverables
Turnaround Time
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Strain Adaption & Characterization: Initial tech transfer, small-scale growth studies, and assessment of growth robustness under process variations.
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Media Optimization: Rational design and screening of defined and complex media formulations; replacement of animal-derived components.
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Critical Process Parameter (CPP) Optimization: Tuning of pH, temperature, agitation/shear rate, Dissolved Oxygen (DO) (for aerobes) or strict anaerobicity (for anaerobes), and feed strategies (for fed-batch).
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Scale-Up Feasibility: Moving from small-scale (e.g., shake flasks/benchtop bioreactors) to pilot-scale (e.g., 50L, 100L) to establish transfer protocols and mass transfer dynamics.
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Master & Working Cell Bank (MCB/WCB) Generation: Preparation of well-characterized, genetically stable cryovials under stringent principles to serve as the starting material for all future production.
Downstream Process Development (Harvest & Formulation)
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Cell Harvesting & Concentration: Optimization of closed-system unit operations, including Tangential Flow Filtration (TFF) or centrifugation, to separate cells from the spent media while minimizing cell stress and oxygen exposure.
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Cell Stabilization & Preservation: Development of robust preservation strategies, primarily Lyophilization (Freeze-Drying) or spray drying, to maintain viability and stability over the shelf-life.
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Final Drug Substance/Drug Product Formulation: Formulation development for the final dosage form (e.g., encapsulated powder, liquid suspension) suitable for administration.
Sample Submission & Requirements
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Strain/Consortium: A vial of the LBP strain (purified isolate or defined consortium mixture).
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Growth History: Original culture conditions, media composition, and any known sensitivities pH, DO, temperature, shear).
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Potency Assay: The validated method (e.g., CFU/mL or functional assay) used to measure the therapeutic activity of the strain.
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Regulatory Status: Details on the strain's origin, identity, and any safety/toxicity data.
Deliverables & Documentation
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Final LBP Drug Substance: Lyophilized or frozen bulk material (non-GMP, research-grade).
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Detailed Batch Records: Comprehensive documentation of all materials, equipment, and process parameters used.
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Process Development Report: Full report on media, CPP optimization, yield, stability, and downstream processing results.
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QC Analytical Data: Certificate of Analysis (CoA) including identity (16S rRNA or WGS), purity, viability (CFU/mL), and bioburden.
Turnaround Time
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Project Initiation & Tech Transfer: 4-6 Weeks
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Media & Upstream Optimization: 8-12 Weeks
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Process Definition & Pilot Run: 6-8 Weeks
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MCB/WCB Generation: 10-14 Weeks
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Final Report & Tech Transfer: 1-2weeks
Ready to advance your Live Biotherapeutic Product? Click here to submit an inquiry and receive a customized project proposal.
Our Core Advantages
Anaerobic Expertise
Specialized equipment and procedures for handling strict anaerobes and multi-strain consortia, which are common in gut-derived LBPs.
Scalability Focus
Dedicated process engineers who design for seamless transition from lab-scale to 100L+ manufacturing, focusing on critical process and quality attributes.
De-risking to IND
All process development activities are documented to meet regulatory expectations for CMC (Chemistry, Manufacturing, and Controls) sections of an IND filing.
Advanced Analytics
Access to cutting-edge QC methods, including next-generation sequencing (NGS) for genetic stability, and UPLC-MS for metabolite profiling.
Customized Solutions
Flexible service packages for single strains, engineered microbes, or complex defined consortia.
Applications
Biotechnology Startups: Companies with novel LBP candidates needing rapid, high-quality CMC development to reach IND filing.
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Pharmaceutical Companies: Pharma groups expanding into microbiome therapeutics requiring external, specialized fermentation capacity.
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Academic/Research Labs: Translating promising research strains into scalable, pre-clinical material.
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Probiotic Companies: Developing next-generation probiotics NGPs that require drug-like regulatory rigor.
The Necessity for Specialized Fermentation
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Strain Specificity: Each LBP strain (especially strict anaerobes or fastidious consortia) has unique growth, nutrient, and environmental requirements (e.g., pH, DO, temperature) that demand tailored process development.
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Viability & Potency: Therapeutic efficacy relies on a high yield of viable, functional organisms and/or their key metabolites. Generic fermentation processes often fail to maintain these critical quality attributes (CQAs).
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Scalability & Regulatory Compliance: Successful drug development requires a process that is reproducible, scalable to clinical and commercial volumes, and compliant with standards, including meticulous control over raw materials and contaminants.
Ready to de-risk your LBP manufacturing process? The complexity of LBP scale-up requires a partner with proven success, not just theory. Take the next step towards a robust, scalable product. Contact our LBP Fermentation Experts today for a no-obligation, confidential consultation. Let's discuss your specific strain characteristics, target yield, and timeline. Partner with us to transform your discovery into a commercially viable therapeutic.
Ready to stabilize your next-generation live therapeutic? Contact us today for a confidential consultation and proposal.
Frequently Asked Questions (FAQs)
Can you handle strict anaerobic bacteria?
Yes. We have purpose-built anaerobic chambers, specialized media preparation techniques, and sealed bioreactor systems that maintain strict oxygen control (pDO < 0.1%) essential for obligate anaerobes, minimizing viability loss during fermentation and harvest.
What is the typical lead time for a process development project?
A comprehensive process development project, from initial strain characterization to final process lock and report, typically takes 4-6 months. This can be expedited for simpler, well-characterized strains or extended for complex consortia.
What is the minimum scale you can work with?
Our initial optimization and screening phases start at benchtop-scale (1L-10L). For final process lock, we typically perform a pilot run (50L-100L) to provide sufficient, representative drug substance and prove scalability.
How do you ensure the genetic stability of the LBP strain?
Genetic stability is ensured through: 1) The creation of a Master and Working Cell Bank with limited passages; 2) Monitoring growth over multiple generations; and 3) Using Whole-Genome Sequencing (WGS) and/or NGS analysis to detect genetic drift or mutations in key functional genes following fermentation.
