Plasmid

CN EN IT TC JP

Plasmid
RNA

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

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

MAH

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

Focus on
microbial expression system
CDMO service leader

CONTCT US

TEL: +86-523-86285566

Address: Building 29, No. 801, Jiankang Avenue, Taizhou, Jiangsu

Email: BD@yaohaibio.cn

Live Chat

Get a Quote

Focus on microbial expression system CDMO service leader

CONTCT US

FOLLOW US

Focus on
microbial expression system
CDMO service leader