The most complex challenge in Live Biotherapeutic Product (LBP) development isn't discovery—it's maintaining viability. You've invested heavily in a promising strain; now, every day of lost potency is a commercial risk. We eliminate that risk. Our end-to-end stability platform is specifically designed for the unique challenges of viable organisms, delivering robust, regulatory-ready data that secures your product's shelf-life and accelerates your IND/BLA submission.
Overview
Creative Biolabs offers comprehensive, end-to-end Stability Development Services specifically tailored for the unique challenges of Live Biotherapeutic Products (LBPs) and probiotics. The stability of an LBP-a product containing living microorganisms-is the critical factor determining its shelf life, storage conditions, and ultimately, its commercial viability and therapeutic efficacy.
Our services encompass both formulation optimization and rigorous stability testing, adhering strictly to international guidelines while employing proprietary microbial stabilization techniques. We partner with clients from strain selection through final commercial formulation to define and achieve a robust shelf life for their living drugs.
Detailed Scope of Services
Our service pipeline is customized to your specific LBP strain and dosage form (capsule, tablet, powder, liquid suspension, etc.).
Workflow
Service Details
Stabilization Development
Samples
Deliverables
Turnaround Time
Excipient Formulation Optimization (Stabilization Development)
This is a critical, strain-specific service focused on maximizing cell viability during the transition to a final drug product (typically lyophilized or dried).
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Cryoprotectant Screening: Evaluation of various sugars, polyols, and polymers to protect cells during freezing/drying processes.
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Lyoprotectant/Stabilizer Blending: Optimization of stabilizer concentrations and ratios to achieve the highest possible viable cell count post-drying.
Stability Storage & Testing (Shelf-Life Assessment)
We provide comprehensive storage and analytical testing under regulatory-compliant conditions.
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Real-Time Stability Studies: Testing product samples under recommended storage conditions for the full proposed shelf-life duration (e.g., 12, 24, or 36 months).
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Accelerated Stability Studies: Testing samples under exaggerated stress conditions (high temperature/humidity) to predict degradation kinetics and quickly estimate shelf life.
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Analytical Testing: Routine testing for key parameters: Potency (Viable Cell Count/CFU), Moisture Content, Purity, Identity, pH, and Dissolution Profile (for dosage forms).
Sample Submission & Requirements
To initiate a Stability Development project, clients typically provide:
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Microbial Strain: Purified, characterized working cell bank (WCB) or master cell bank (MCB) of the LBP.
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Process Information: Detailed Standard Operating Procedures (SOPs) for upstream fermentation and initial downstream purification.
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Target Product Profile (TPP): Desired final dosage form, required dose (CFU/unit), and target shelf life (e.g., 24 months).
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Previous Data (if any): Any existing preliminary stability or viability data.
Deliverables & Documentation
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Interim Formulation Report: Initial screening results, optimized excipient formula, and proposed manufacturing parameters.
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Certificate of Analysis (CoA): Batch-specific QC data for stability lots placed on study.
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Comprehensive Final Report: Detailed stability protocols, raw data, statistical analysis (decay plots, predicted shelf life), and formal storage recommendations.
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Materials: Optimized excipient blends and final formulation material generated during small-scale runs.
Turnaround Time
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8-12 Weeks (for Interim Formulation Phase II screening)
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COA will be issued after each testing interval.
Ready to ensure the long-term stability and potency of your biotherapeutic product? Contact Us Today for a Quote and Technical Consultation!
Our Advantages: Why Partner With Us?
LBP Specialization
We are a "One-Stop-Shop" focused exclusively on microbial therapies, offering unparalleled expertise in handling and stabilizing living organisms.
Customized Solutions
Recognizing that stability is strain-specific, we do not use 'cookie-cutter' formulations, ensuring maximum viability for your product.
Regulatory Readiness
All studies are designed and conducted under strict quality systems, producing data suitable for submission to global regulatory bodies.
State-of-the-Art Facilities
Dedicated compliant stability storage chambers with continuous monitoring and backup systems.
Applications
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Biotechnology & Pharmaceutical Companies: Developing LBPs or microbiome-based drugs.
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Nutraceutical & Functional Food Developers: Seeking to extend the shelf life and validate the potency of probiotic supplements and functional food ingredients.
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Academic & Research Institutions: Requiring formal stability assessments for promising proprietary strains before commercial licensing or spin-off creation.
The Necessity of Stability Development
Stability testing is not merely a regulatory requirement; it is foundational to LBP development. Living organisms are highly susceptible to environmental stresses (heat, moisture, oxidation, and mechanical stress), which can lead to rapid viability loss. Stability development ensures:
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Efficacy: Guaranteeing that the stated therapeutic dose remains viable throughout the claimed shelf life.
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Regulatory Compliance: Establishing critical quality attributes (CQAs) and defining appropriate storage, packaging, and expiry dating.
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Logistical Feasibility: Determining realistic shipping and storage requirements for commercial distribution.
Your Path to LBP Confidence is Clear. Unlike general stability labs, our expertise is hyper-focused on anaerobic, aerobic, and microaerophilic LBPs, utilizing specialized cryopreservation and formulation techniques proven to maximize viable cell count (VCC) over time. We don't just run samples; we optimize your formulation and packaging for guaranteed results.
Ready to secure the future of your Live Biotherapeutic Product? Contact us today to schedule a free consultation and receive a custom proposal for your Stability Development needs. Inquire Now!
Frequently Asked Questions (FAQs)
How does LBP stability development differ from traditional small-molecule drug stability?
Traditional stability measures chemical purity and degradation products. LBP stability is fundamentally about viability (the number of living cells, measured in CFU/g or mL) and protecting the entire biological system, which is far more sensitive to stress and temperature than a chemical compound.
What is the minimum amount of sample required?
Sample requirements vary based on the number of conditions (temperature, humidity) and the duration of the study. We provide a detailed quote upon request, but typically require sufficient material to allow for scheduled pulls plus reserve samples.
Can you optimize stability for lyophilized (freeze-dried) and liquid formulations?
Yes. We specialize in both. Lyophilization is often preferred for maximum shelf life but requires extensive cryoprotectant optimization. Liquid formulations require careful attention to buffers, pH, and potential oxygen scavenging systems.
What is the standard industry goal for shelf life?
The common commercial goal is 24 months or longer under refrigerated conditions (2-8°C). Our services are aimed at helping you achieve competitive shelf-life claims.
