Twogene is a contract development and manufacturing organization (CDMO) specializing in the process development and large-scale production of plasmid DNA (pDNA) and proteins for the cell and gene therapy industry. The company addresses the need for GMP-compliant manufacturing by providing fast-turnaround production capabilities, ranging from research-grade to large-scale GMP-grade batches, ensuring high-quality outputs for preclinical, clinical, and commercial applications.
Funding
Funding not disclosed
Founders
Product
Problem
The cell and gene therapy industry faces challenges in securing reliable and scalable manufacturing of plasmid DNA (pDNA) and proteins, which are critical components for their therapeutic products. Traditional manufacturing processes can be slow, costly, and may not meet the stringent quality requirements for clinical and commercial applications.
Solution
Twogene is a contract development and manufacturing organization (CDMO) that specializes in the GMP-compliant production of plasmid DNA (pDNA) and recombinant proteins. The company offers a comprehensive suite of services, from sequence optimization and cell banking to large-scale manufacturing in bioreactors ranging from 15L to 500L. Twogene utilizes a proprietary, fast-turnaround process to accelerate timelines and improve pDNA yields. Their manufacturing processes are compliant with international GMP guidelines and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), ensuring product quality for preclinical, clinical, and commercial stages.
Target Audience
Twogene serves gene therapy and vaccine companies requiring GMP-compliant plasmid DNA and protein manufacturing, from early-stage research to commercial production.
Features
- Research-grade pDNA production in batch sizes from 1L to 30L
- GMP-grade pDNA manufacturing in bioreactors from 15L to 500L
- Production of linearized pDNA for mRNA applications
- Recombinant protein expression services utilizing microbial fermentation or mammalian cell culture
- Cell banking services, including master and working cell banks, stored in a validated -80 degree environment with online monitoring
- Sequence optimization to enhance pDNA yields
- Fully validated QC processes