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Aseptic Fill & Finish for Cell Therapies
Ensure sterility, consistency, and regulatory confidence at every step.
Protect the Integrity of Your Therapy - From Final Fill to First Dose
Made Scientific's aseptic fill & finish services deliver the specialized handling, precision, and quality control essential for successful cell therapy drug production. Our experienced team, purpose-built facilities, and compliant and reliable operations deliver the exact requirements you need for your cell therapies.
Protect Viability, Preserve Potency, Ensure Precision
We understand that aseptic fill & finish operations for cell therapies present unique challenges beyond those of traditional biologics. Our BSL-2 and GMP compliant facilities support sterile manufacturing from clinical supply to commercial batches. Our facilities and workflows are designed to maintain quality, potency, and compliance, so you can move forward with confidence.
- Specialized 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
- Comprehensive documentation and traceability
Delivering What You Need Most: Quality, Viability, and Safety
Made Scientific provides everything you need to ensure safe, consistent, and compliant fill & finish 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
Comprehensive 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 - up to 500 vials per batch; semi-automated fills - up to 1500 vials per batch (2025)
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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 seamlessly with comprehensive quality control testing to ensure a high quality final product and timely release 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
Partner with Made Scientific for Your Cell Therapy Aseptic Fill & Finish Needs
Connect with our team to explore how our specialized aseptic capabilities can support your therapeutic goals