The Power of One
Samsung Biologics is dedicated to advancing the development and manufacturing of high-quality biomedicines that enrich lives. Through our commitment to innovation and
Process Development excellence, we continuously enhance our technologies to meet the highest CGMP manufacturing standards of safety, efficacy, and reliability.
Our on-site Bio R&D Lab delivers cutting-edge mRNA-LNP technologies, enabling agile, scalable mRNA manufacturing and reliable, on-time delivery for every client.
Custom mRNA and LNP Manufacturing Services
With the highest regulatory compliance and a specialized team of mRNA development and manufacturing experts, Samsung Biologics provides customized, end-to-end support for mRNA and lipid nanoparticle (LNP) production. Our services accommodate any scale-up study, ensuring precision, reproducibility, and compliance throughout all Biopharma Development stages.
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- Scope
- mRNA / saRNA / circRNA
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- IVT* Batch Capacity
- 0.1 L to 200 L Single-use
*In vitro transcription
Agile mRNA Development and Analytical Testing
Our fully integrated mRNA GMP manufacturing services cover process development, analytical testing, and product characterization, enabling seamless progression from early Late Discovery to clinical and commercial production. Our scientific approach ensures robust scalability and compliance with global Quality standards.
- Process
- mRNA / LNP Process Development
- Non GMP mRNA / LNP DS
- Analytics
- Method Development / Qualification
- Method Transfer to QC
CGMP mRNA / LNP DS
Seamless Tech Transfer and Flexible Scale-Up
Flexible scale-up precisely tailored to your needs
In today’s dynamic mRNA therapeutics development landscape, rapid and precise tech transfer is essential. Samsung Biologics offers seamless technology transfer with flexible scale-up capabilities from laboratory to commercial production. This ensures that your projects advance efficiently across Non-GMP / CGMP Manufacturing facilities without disruption.
Agile mRNA Development and Analytical Testing
From pDNA linearization to fill-finish, our comprehensive mRNA manufacturing workflow ensures on-time, in-full delivery of mRNA vaccines and therapeutics. Through robust Drug Product Manufacturing and Drug Substance Manufacturingintegration, Samsung Biologics enables efficient upstream and downstream operations under strict CGMP conditions.
- pDNA- Linearization
- mRNA Synthesis IVT C/T
- mRNA Purification(UFDF, Chromatography)
- LNP Formulation
- LNP Purification (TFF)
- Aseptic mRNA filling
- Labeling & Packaging
- Automated Warehouse
In-House Bioanalytical and Quality Control Services
Our fully in-house bioanalytical services for mRNA in vitro transcription (IVT), LNP formulation, and fill-finish ensure rapid turnaround and regulatory compliance. Samsung Biologics maintains comprehensive testing capabilities including
Analytical Testing, IPC testing, release testing, and biosafety verification.
Testing Capabilities:
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IPC* Testing
*In-process control
- • Physical chemistry-based assays
- • Mass-based assays
- • Plate reader-based assays
- • Cell-based assays
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Release Testing
- • In-process control
- • Compendial testing
- • Microbial identification
- • Sterility testing
- • CCIT/Extractable volume
- • Particulate testing
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Biosafety Testing
- • Bioburden testing
- • Endotoxin detection and quantitation
*In-process control
Innovative mRNA Sequence Design and Scientific Support
Samsung Biologics offers proprietary mRNA sequence design and AI-driven optimization for improved protein expression and stability. Our Biopharma Manufacturing capabilities support research collaboration and RNA therapeutics development tailored to project-specific requirements.
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mRNA sequence design
- • AI-based optimal sequence design algorithm platform with in-silico and in vitro validation
- • Customized mRNA sequence design service with improved protein expression profile and mRNA stability
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Poly(A) tail shield
- • Proprietary mRNA tail sequence and structure with manufacturing advantages
- • Recombination-resistant design and QC-friendly homopolymeric characteristics
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circular RNA (circRNA)
- • Manufacturing platform for novel forms of RNA structure
- • High circularization efficiency and purification of biologically active fractions
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