Your next clinical milestone shouldn't be derailed by formulation instability. For LBPs and Probiotics, successful lyophilization is the critical difference between a groundbreaking therapeutic and a failed batch. Creative Biolabs doesn't just 'run cycles'—we engineer stability using a data-driven, microbe-specific approach. Partner with us to de-risk your program, accelerate time-to-market, and ensure maximum viable cell recovery, even under non-ideal storage conditions.
Overview
Lyophilization, or freeze-drying, is the gold standard for stabilizing sensitive biological materials, especially Live Biotherapeutic Products (LBPs) and probiotics. Creative Biolabs offers comprehensive Lyophilization Development Services to ensure the maximum viability, stability, and efficacy of your drug candidates and research materials over extended periods.
Our specialized platform focuses on developing customized, robust, and scalable freeze-drying cycles tailored to the unique physiological requirements of each organism or molecule. By meticulously optimizing cryoprotectants, excipients, and process parameters, we help you overcome formulation challenges, extend product shelf life, and transition seamlessly from R&D to large-scale manufacturing.
Detailed Scope of Services
Our comprehensive service portfolio covers all stages of LBP and Probiotic lyophilization development:
Workflow
Service Details
Stability and QC
Samples
Deliverables
Turnaround Time
Pre-Lyophilization Formulation Development
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Excipient Screening: High-throughput screening of various cryoprotectants (protect cells during freezing) and lyoprotectants (stabilize cells during drying) to find the optimal combination for the specific strain.
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Thermal Characterization: Determining the product's critical temperatures using analytical tools like Modulated Differential Scanning Calorimetry (mDSC) and Freeze-Dry Microscopy (FDM).
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Aseptic Filling & Loading: Optimization of filling parameters (viscosity, density) and controlled loading of vials/containers into the lyophilizer to ensure batch uniformity.
Lyophilization Cycle Development & Optimization
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R&D Cycle Design: Initial cycle development based on thermal data, focusing on maximizing cell viability (CFU recovery).
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Process Optimization: Fine-tuning freezing, primary, and secondary drying parameters for robustness and efficiency (shorter cycle time, lower cost).
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Scale-Up Modeling: Using mechanistic modeling to predict and calculate optimal primary drying conditions (shelf temperature, chamber pressure) at a larger manufacturing scale.
Stability and Quality Control
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Accelerated & Real-Time Stability Studies: Testing product viability and integrity under compliant conditions to predict shelf life.
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Analytics & Release Testing: Comprehensive analysis of the final lyophilized product.
Sample Submission & Requirements
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Required Sample: Lyophilization-ready material (e.g., bacterial/yeast pellet, cell suspension, purified protein).
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Quantity: Minimum of 50 mL of concentrated suspension or as agreed upon in the technical plan, sufficient for 20-30 optimization runs.
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Concentration: Must meet the required concentration for the final dosage form.
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Format: Must be shipped frozen (dry ice) or refrigerated, depending on the material and initial agreement.
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Information: Full growth media/buffer composition, desired final dosage form (vial size, cake appearance), and known stability issues.
Deliverables & Documentation
You will receive a complete data and knowledge package for seamless progression to clinical and commercial manufacturing:
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Lyophilization Recipe & Protocol: A fully validated, optimized, and scalable cycle for your specific LBP/Probiotic strain.
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Stability Data Package: CFU recovery data, residual moisture analysis, and projected shelf-life based on accelerated studies.
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Critical Parameter Report: Comprehensive thermal characterization and identification of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
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Technology Transfer Package: Detailed documentation to facilitate smooth transfer to a larger-scale CDMO or your own manufacturing facility, ready for IND/IMPD submission.
Turnaround Time
Typical Total Turnaround Time: ~20-30 Weeks (Varies significantly based on strain complexity, desired stability, and regulatory phase.)
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-Specific Expertise
Deep scientific understanding of microbial cryo-injury, strain-specific protective mechanisms, and anaerobic processing requirements.
QbD & Mechanistic Modeling
Cycles are scientifically robust, highly efficient, and meet stringent regulatory requirements (FDA, EMA), minimizing manufacturing risk.
State-of-the-Art Equipment
Access to high-end, instrumented pilot-scale lyophilizers equipped with PAT for precise control and data collection.
Seamless Tech Transfer
Our documentation is tailored for manufacturing, significantly accelerating your time-to-clinic or time-to-market.
Applications
Our services are essential for any organization developing live microbial products:
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Emerging Biopharma/Biotech Companies focused on Live Biotherapeutic Products (LBPs) for indications like C. difficile infection, IBD, or oncology.
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Probiotic/Functional Food Companies seeking to elevate their product stability from commercial dietary supplement standards to high-viability, long-shelf-life formulations.
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Academic Research Groups requiring a robust, small-batch lyophilization protocol for preclinical or early-phase clinical material.
The Necessity of Professional Lyophilization Development
Live microorganisms, by their nature, are highly sensitive to environmental stresses like moisture, heat, and oxygen. Lyophilization is the gold standard for long-term preservation, as it removes water while keeping the cell structure intact. However, the process itself-involving freezing and extreme dehydration lethal without proper optimization.
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Maximize Cell Viability: Minimize cell death during the freezing and drying phases to meet the high Colony Forming Unit (CFU) targets required for efficacy.
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Ensure Long-Term Stability: Achieve ultra-low residual moisture (typically <2%) to prevent microbial metabolism and degradation, enabling storage at refrigerated or ambient temperatures.
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Establish a Robust, Scalable Process: Develop a cycle that is reproducible across different scales (from R&D to commercial manufacturing) and equipment, satisfying Quality by Design and regulatory requirements.
Our service is critical for: Maximizing viable cell count (potency), ensuring long-term thermal stability, and achieving cost-effective, reproducible manufacturing.
Stop compromising on stability. Start engineering it. The success of your Live Biotherapeutic depends on a lyophilization process that preserves potency and ensures manufacturability. Don't waste valuable time and resources on a generic approach. Bring us your most challenging strain-Creative Biolabs is ready to deliver a ready, optimized formulation that meets your precise shelf-life and regulatory requirements.
Ready to stabilize your next-generation live therapeutic? Contact us today for a confidential consultation and proposal.
Frequently Asked Questions (FAQs)
What is the most critical challenge for LBP lyophilization?
Cell Viability-achieving high CFU recovery after the process. Live microorganisms are extremely vulnerable to freezing and dehydration stress. Our advanced formulation screening and gentle cycle design are specifically focused on mitigating this.
What sample information do you need to start the process?
We require the target microbial strain (Master Cell Bank), preliminary data on its growth media and fermentation yield, target dose/CFU, and desired final container closure system (vial, bulk, etc.).
How does this service support regulatory submissions (IND/BLA)?
We operate under standards for R&D/Phase I material. Our reports include full QbD documentation, defining the relationship between Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), which is a key component of the Chemistry, Manufacturing, and Controls (CMC) section of an Investigational New Drug (IND) or Biologics License Application (BLA).
How do you determine the best cryoprotectant?
We use a rational screening process. We test a panel of proven excipients (e.g., various sugars, polymers, and proprietary blends) in combination with preliminary freeze-thaw cycles. The best cryoprotectant is the one that minimizes viability loss while supporting a robust final cake structure for your specific organism or molecule.
