The quality of your Live Biotherapeutic Product (LBP) starts at the source. The establishment of a robust, fully characterized Master Cell Bank (MCB) and Working Cell Bank (WCB) is the single most critical step in transitioning your novel discovery from the lab bench to a clinical or commercial product. As a specialized Contract Research Organization (CRO), Creative Biolabs provides end-to-end cell banking services specifically tailored for the unique challenges of microbial and live organism therapeutics.
Overview: The Critical Role of Cell Banks in LBPs
Live Biotherapeutics (LBPs) are novel drug products containing live microorganisms (e.g., bacteria or yeast) intended to prevent, treat, or cure human diseases. Unlike traditional biologics, LBPs involve living, metabolically active entities, making the consistency of the starting material paramount.
The two-tiered cell banking system (MCB and WCB) ensures:
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Genetic Stability: Minimizing the number of passages from the original isolate to prevent genetic drift, mutation, and phenotype changes in the production strain.
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Product Consistency: Providing a uniform, authenticated, and fully tested starting material for every production batch over the lifetime of the product.
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Regulatory Compliance: Meeting stringent global regulatory requirements for clinical and commercial manufacturing.
Detailed Scope of Services
Standardized Workflow
Service Details
Our services are fully customizable to accommodate the specific needs of your LBP, including obligate anaerobes, facultative anaerobes, and yeast strains.
Deliverables
Turnaround Time
Services
Cell Line/Strain Authentication & Qualification
Comprehensive testing on the client-provided starting material (Research Cell Bank), including 16S rRNA sequencing, species identification, whole-genome sequencing (WGS), and confirmation of desired phenotype/function. This is essential for ensuring the correct, non-contaminated organism is the basis of the drug product.
Media & Process Optimization
Development and qualification of specialized, chemically defined, or complex media and cryopreservation protocols (e.g., use of custom cryoprotectants) for maximum viability and anaerobic-specific growth conditions. This is crucial for maximizing the post-thaw viability and growth kinetics of often sensitive LBP strains.
Master Cell Bank (MCB) Generation
Manufacturing of up to 200-300 vials of MCB under compliant conditions. Includes strict environmental monitoring and limited passage numbers. Provides the primary, long-term source of material for all future production.
Working Cell Bank (WCB) Generation
Manufacturing of up to 500-1,000+ vials from a single MCB vial. Process is highly optimized for scale-up consistency and maximum yield/viability. Provides a readily available, tested source for routine manufacturing campaigns, preserving the MCB.
Full QC Release Testing (MCB & WCB)
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Identity: Genotyping (e.g., WGS, DNA fingerprinting), Plasmid Retention (if applicable).
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Purity/Safety: Sterility, Mycoplasma, Endotoxin, and Adventitious Virus Testing.
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Potency: Viability (CFU/mL), Growth Profile, Functional Assay (if provided).
To ensure safety, traceability, and consistency of the therapeutic organism.
Sample Requirements
To initiate the project, clients must provide:
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Production Strain: A vial of the Research Cell Bank (RCB) or lead isolate (or a pure, characterized culture) with confirmed identity and a minimal passage history.
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Strain Information: Growth medium, culture conditions (aerobic/anaerobic), known passage number, cryopreservation medium, and basic viability data.
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Regulatory Documents: Relevant safety and risk assessment data.
Deliverables
Upon project completion, you will receive a comprehensive package:
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MCB & WCB Vials: Cryovials of your Master and Working Cell Banks, securely stored in our facility or shipped to your designated cGMP storage site.
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Certificate of Analysis (CoA): Official document confirming the passing of all required QC Release Tests.
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Comprehensive Batch Records: Detailed documentation of the entire cell banking process, including materials, equipment, personnel, environmental monitoring, and in-process controls.
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Final Report: Summarizing the process, analytical results, genetic stability assessment, and compliance statement.
Turnaround Time
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Phase I: Initiation & Pre-Banking. 4-6weeks
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Phase II: MCB Production & Characterization. 6-8 Weeks
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Phase III: WCB Production & Final Release. 6 -8 Weeks
Timeline subject to organism-specific growth rate and testing complexity. Excluding long-term stability studies.
Ready to start your Cell Banking project? Click here to request a quote and consultation!
Our Competitive Advantages
LBP-Specific Expertise
Deep knowledge in handling, culturing, and cryopreserving challenging strains, including strict anaerobes, which require specialized containment and processing equipment.
cGMP-Aligned & Future-Proof
All processes adhere to the latest and global regulatory standards, ensuring your banks are ready for seamless transition to IND-enabling studies, clinical trials, and commercial production.
Integrated LBP Platform
Service is fully integratable with our downstream LBP Process Development and cGMP Manufacturing (fermentation, purification, formulation), providing a single-source solution for your program.
Advanced Characterization
Routine use of cutting-edge molecular tools (WGS, dPCR) for high-resolution genetic identity and stability testing, providing superior confidence in the homogeneity of your banks.
Robust Security & Storage
State-of-the-art, redundant, and continually monitored cryostorage facilities ensure the absolute long-term security of your critical starting material.
Applications
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Emerging Biotech & Start-ups: Companies transitioning their LBP discovery from academic research to preclinical development, requiring their first regulatory-compliant cell banks.
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Pharmaceutical Companies: Established firms diversifying into the microbiome space, needing expert support for the unique challenges of LBP manufacturing.
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Academic/University Labs: Researchers requiring cell banks for early-phase human studies.
Necessity of Cell Banking
Our service is a meticulously controlled, phased process designed to transform your single, validated microbial strain into thousands of cryovials of uniform, authenticated banking material.
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Master Cell Bank (MCB) Generation: A single colony or a defined culture of the selected, fully characterized production strain is expanded to an intermediate volume, carefully characterized, aliquoted into vials, and cryopreserved. The MCB is the original seed stock, used only for the creation of WCBs.
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Working Cell Bank (WCB) Generation: A single vial of the MCB is thawed, expanded over a limited, predefined number of passages, aliquoted, and cryopreserved. The WCB is the material used to inoculate all subsequent production fermentations, protecting the precious MCB.
This dual-bank system is the foundation of quality control, ensuring that all subsequent drug substance batches originate from the same characterized genetic source.
Your live biotherapeutic discovery journey is unique, and your cell bank strategy should be too. Don't settle for off-the-shelf solutions. Our expert team is ready to serve as an extension of your own lab, applying deep experience in regulatory-compliant Master and Working Cell Bank (MCB/WCB) generation specifically for LBP platforms. We offer flexible, phased programs that scale from early-stage discovery to full cGMP readiness, ensuring your bank is robust, fully characterized, and future-proof. Secure the foundational quality of your novel therapeutic with a dedicated partner. Please contact us for more details.
Ready to Secure Your LBP Program? A compliant and stable cell bank is a non-negotiable step on the path to the clinic. Partner with our LBP experts to establish the highest quality foundation for your drug development.
Frequently Asked Questions (FAQs)
Why is an MCB/WCB necessary for an LBP?
Because LBPs are live, replicating organisms, they are susceptible to genetic mutation (drift) over time and passages. The two-tiered system minimizes the number of cell divisions between the MCB and the final production batch, maintaining the genetic, phenotypic, and functional stability of your therapeutic strain as required by regulatory agencies.
Can you handle obligate anaerobic strains?
Yes. We have dedicated, state-of-the-art anaerobic glove boxes and environmental chambers integrated into our cleanrooms, specifically designed for the manipulation, expansion, and cryopreservation of oxygen-sensitive LBP strains under strictly controlled conditions.
What makes LBP cell banking different from monoclonal antibody cell banking?
The primary difference lies in the organism type (microbial vs. mammalian) and the associated QC risks. LBP banking requires specialized considerations for anaerobicity, viability (CFU/mL), rapid growth cycles, and unique contaminant testing (e.g., bacteriophage detection, specific microbial contaminants).
Do you offer long-term storage?
Yes, we offer secure, contract long-term storage in vapor-phase LN2 with dual redundancy at our audited facilities, alongside our global distribution service.
