Drug Product Manufacturing for Biologics
As a leading biologics CDMO, Samsung Biologics delivers CGMP-compliant drug product manufacturing services tailored to clinical and commercial needs. Our aseptic fill-finish facilities support efficient, end-to-end workflows - ensuring timely delivery, global regulatory compliance, and premium quality for biologics and small molecules.
Our CGMP manufacturing infrastructure is purpose-built to scale with your pipeline, and integrates seamlessly with process development and drug substance manufacturing
Our CGMP manufacturing infrastructure is purpose-built to scale with your pipeline, and integrates seamlessly with process development and drug substance manufacturing
Flexible Aseptic Fill-Finish Capabilities
Our aseptic fill-finish lines are designed for high-throughput performance and flexible batch sizes ranging from 5 L to 2,500 L. With capacity for up to 350,000 vials per day, our services support rapid scale-up across biologics and small molecule products.
Our integrated approach to drug product manufacturing enables clients to transition smoothly from late discovery through cell line development, supporting on-time, compliant delivery to global markets.
Our integrated approach to drug product manufacturing enables clients to transition smoothly from late discovery through cell line development, supporting on-time, compliant delivery to global markets.
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Aseptic Filling Services
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We provide clinical and commercial-scale aseptic filling for vials and prefilled syringes, covering both biologics and small molecule products.
Our automated lines support rapid changeovers with strict adherence to CGMP practices.
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Lyophilization (Freeze-Drying)
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Our lyophilization services offer scalable freeze-drying capacity for biologics and sterile injectables.
Fully integrated within our CGMP drug product suites, this capability helps maintain product stability and extend shelf life.
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Finishing and Inspection
- We offer automated visual inspection systems and bulk secondary packaging to support batch release and product integrity. Quality assured through every stage of biopharma manufacturing.
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Cold Chain Storage & Shipping
- We offer full cold chain logistics, with walk-in storage and freezer capabilities from 2-8℃ down to -70℃. Passive and active shipping methods ensure product integrity during global distribution. Our facility supports deep freezer sstorage and offers scalable analytical testing to validate stability.
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Global Regulatory Support
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Our services are approved in 20+ markets, with support for Type V DMFs and full CMC documentation.
Clients benefit from integrated regulatory affairs and quality assurance teams to support compliant market entry worldwide.
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Your Trusted Fill-Finish Partner
The ultimate goal of aseptic fill-finish services is to ensure the safe delivery and administration of quality drug products to patients. From dedicated experts to flexible filling capabilities and storage, our processes are optimally streamlined to ensure minimal safety risks.
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Experienced MSAT & Tech Transfer
- Our MSAT experts lead process characterization, scale-up, and regulatory documentation for drug product projects, ensuring fast, smooth transitions to clinical or commercial supply.
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Scalable Filling Solutions
- Our fill-finish lines support large batch sizes and a wide range of container types, tailored to your product needs. We handle both clinical fill-finish and global commercial supply.
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Temperature-Controlled
- We offer a full spectrum of storage options from ambient conditions to deep cold (-70℃), supporting stability for temperature-sensitive products including mRNA therapeutics.
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