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Trusted partner for high-quality pDNA and mRNA manufacturing

Plasmid DNA (pDNA) is a critical raw material required for vaccines and other advanced modalities from initial research to commercial. With rising evidence of the effectiveness of these modalities, there is a growing demand for high-quality pDNA for the production of messenger RNA (mRNA) vaccines, RNA vaccines, viral vector vaccines, and ATMP.

Based on 30 years of experience, Syngene has developed platform processes to streamline and optimize pDNA and mRNA production, ensuring consistency and quality at any scale.

We offer pDNA production of 2L, 10L and 50L scale. Our facility is also equipped to offer large-scale cGMP production of up to 500L scale, adhering to the highest industry standards of quality and safety.

Our range of pDNA offerings across research grade, pre-GMP grade, and GMP grade are given below. We also offer custom pDNA tailored to meet client-specific research or regulatory requirements.

Our range of offerings for pDNA

Our GMP-grade mRNA manufacturing expertise

Our offering spans the complete cGMP mRNA manufacturing process from the production of high-quality plasmids and in vitro transcription (IVT) mRNA process to lipid nanoparticle (LNP) formulation and Fill/Finish.

We have expertise in scaling processes to cGMP scale, employing robust analytical methods, and developing highly efficient manufacturing processes.

Syngene’s cGMP mRNA manufacturing process expertise
EDTA: Ethylenediaminetetraacetic acid; LNP: Lipid Nanoparticle

Why Syngene for mRNA manufacturing

Automated continuous process: We harness the power of automation to provide efficient and reliable continuous manufacturing processes, reducing production variability and increasing productivity.

Scale-up technology: Our advanced technology enables seamless scale-up to 50L using automated continuous processes. We employ automated cell lysis equipment and offer enzyme-free processes to ensure product integrity and quality.

Robust Analytical methods: We employ a range of analytical methods, including AGE, AEX, A260/280, HCD, HCP, and HCR, to guarantee the purity and integrity of your nucleic acid products.

CMC and regulatory support: Our team of experts assist clients through the entire chemistry manufacturing and controls (CMC) process. We offer comprehensive regulatory support to ensure a smooth path from development to commercialization.

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