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Plasmid Overview

The plasmid is small closed circDNA molecules with the ability to replicate autonomously. It can express carried genetic information. The artificially constructed and produced plasmid DNA carrier is commonly used for gene therapy research and drug preparation currently.

It have different applications in gene cell therapy. For example, it is used as raw materials to construct viral carrier and transfer target genes in cell therapy (CART, TCRT, UCART) and gene therapy products for adeno-associated viruses, starting material in the transcription template of mRNA vaccines, and final products for gene cell therapy in the production of DNA vaccine.

Plasmid CDMO Service Overview
Yaohaibio has abundant experience in process development and GMP production in large-scale production of plasmid for different intended uses. We provide one-stop upstream and downstream process development and commercial production. Thnaks to modern production lines and advanced GMP production facilities, the production scale can be flexibly switched to meet requirements for various stages of preclinical CMC, clinical and commercial production of plasmid CDMO.
Plasmid CMC and GMP Production Project Experience

Naked plasmid

Viral carrier production (AAV, lentivirus)

Cellular gene therapy

DNA vaccines/DNA drugs

mRNA production

Plasmid CDMO service covers the entire product development cycle
Plasmid construction
Gene synthesis and vector construction
Strains and strain bank establishment
Establishment of primary strain, primary strain bank and secondary strain bank
Process development
Fermentation process development, purification process development and drug product process development
Quality study
Specification establishment, and development, transfer and validation of analytical method
IND/GMP sample production
7-2001L fermentation production, downstream purification process, sterile drug product filling
Product release
Complete the quality control system, improve the quality assurance system, and comply with laws and regulations
Registration Application
IND application, NDA application, international application (FDA, EMA), registration consulting
Commercial production
Plasmid CDMO platform advantages
  • Strain bank

    -Clear traceability of strain

    -Stable high-expression strain

  • Plasmid process development

    With QbD (Quality by Design) as concept, stable and high yield process is achieved by identifying critical process parameters (CPP) based on CQA (critical quality attribute) using DoE experimental process design.

    -Antibiotic-free fermentation, no animal-derived ingredients

    -High-density fermentation, the high expression: 260 mg/L

    -DNA fragment HCD residue <2 ug/mg

  • Plasmid production

    -5 defferent scales of IND clinical sample preparations, GMP grade production service platforms

    -7L-2000L fermentation scale, meet different production requirements

  • Robust process

    -Multiple production scale of 50L, 100L, 200L, 500L, 1000L, 2000L

  • Project experience

    -Experiences in plasmid CMC and clinical GMP production projects

    -One-stop IND clinical trial application experience

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