Aseptic Fill & Finish for Cell Therapies
Protect the Integrity of Your Therapy - From Final Fill to First Dose
Your cell therapy gets the specialized handling, precision, and quality control that successful drug production depends on, and stays sterile at every step.
We understand that filling and finishing living cells presents challenges beyond those of traditional biologics. Backed by an experienced team and purpose-built BSL-2 and GMP compliant facilities, you can move forward with confidence from clinical supply to commercial batches.
- Aseptic fill & finish designed to maintain viability, prevent aggregation, ensure dose uniformity, and preserve functionality
- ISO 5 filling operations within ISO 7 cleanrooms
- Manual operator & semi-automated fill systems for flexibility and throughput
- Closed-system processing to maintain sterility, cell viability, and product potency
- Temperature-controlled handling for sensitive cellular products
- Full documentation and traceability
Delivering What You Need Most: Quality, Viability, and Safety
You get safe, consistent, and compliant fill & finish, built for cell therapies.
Cell Therapy Expertise
Specialized knowledge in handling cellular products during fill operations
Viability Protection
Processes designed to maintain cell viability and functionality
Temperature Management
Controlled cold-chain handling for temperature-sensitive products
Flexible Formats
Accommodating multiple container formats including vials, bags, and custom container & closure systems
Process and Operator Consistency
Validated systems, operator qualifications, ensuring reliable, reproducible operations
Quality Assurance
Documentation and QC final drug product testing to support regulatory requirements
Comprehensive Fill & Finish Capabilities
Our aseptic fill & finish operations address the unique challenges of cellular products and other modalities, with services including:
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Multi-Modal Support: Cell therapies, monoclonal antibodies, recombinant proteins, peptides, small molecule APIs, diluents, and placebos
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Flexible Filling: Accommodating multiple container formats, including cryostorage tubes, vials, bags, and custom container closures
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Filling Options: including validated manual fills of up to 500 vials per batch and semi-automated fills of up to 1,500 vials per batch (2026)
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Closed System Operations: Minimizing contamination risk when possible through fully-closed liquid handling to final container and closure
- Controlled Environment: ISO 5 filling areas within ISO 7 cleanrooms
- Temperature Management: Controlled cold-chain handling for temperature-sensitive products
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Visual Inspection: Protocols to ensure final product inspection
- Container Closure Integrity: Validated systems ensuring product protection
- Custom Labeling: Product-specific labeling compliant with regulatory requirements
- Final Packaging: Preparation for distribution with appropriate temperature controls
Quality Control Testing & Stability Studies
Our fill & finish operations integrate with quality control testing to release a high quality final product on time for patients.
Final Product Testing
Identity, purity, potency, and safety testing for rapid product release
Release Assays
Qualified and validated (ICHQ2) methods supporting batch release
Stability Assessment
Ongoing stability monitoring under various conditions (ambient, accelerated, long term, in-use, in clinic, shipping)
Documentation
Complete batch records and certificates of analysis; ICH complaint stability protocols
Aseptic Fill & Finish for Your Cell Therapy
Connect with our team to explore how our specialized aseptic capabilities can support your therapeutic goals