R&D and GMP Plasmid
DNA Production

Plasmid DNA production platform complements integrated capabilities enabling cell and gene therapies to be developed, manufactured, and released faster and with greater predictability globally. 

WuXi Advanced Therapies offers R&D and GMP production of bacterial plasmids for use in a wide variety of R&D, clinical, and commercial bioprocessing applications. 

Our integrated platform of capabilities allows for a seamless, end-to-end, single-source approach — from raw and starting materials characterization and process control strategies through plasmid growth, purification and final fill — that ensures efficient plasmid production and release to meet each customer’s exacting needs.

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Program Features

  • Consistent and secure product supply — derived from our robust engineering, manufacturing and analytical quality control capabilities, coupled with a highly trained quality assurance unit.
  • Precise alignment to global guidances/requirements — founded on our long-standing expertise in working with regulatory authorities worldwide.
  • Stable, effective production process platform with highly flexible scalability — featuring separate bacterial banking and plasmid manufacturing facilities and staff.
  • Assured delivery of quality products while keeping critical timelines on track — achieved through quality-driven and client-reviewed GMP batch record documentation, as well as validated processes for change-over and cleaning procedures.

Program Capabilities

  • Single-use consumable and fully closed and automated process.
  • Full and one-stop GMP manufacturing service: from E. coli cell banks to the plasmid production.
  • Yield of E. coli cell banks and plasmids according to customer needs.
  • Manufacturing scalability ranging from production scale of 50 mg to 3000 mg and lot size from 200 mg to ~ 5g.
  • Full quality control and characterization service.
  • Testing programs customized to meet customer requirements.

Applications

BACTERIA BANKING

Microbial bank for any GMP usage such as plasmid production or recombinant protein production.

PLASMIDS

  • Transfection: High-purity, high-homogeneity, low- endotoxin plasmid DNA ideal for transfection application.
  • Gene Therapy: Varies strategy for in vivo plasmids such as ITR-bearing plasmid and big size plasmid; ensures high yields and quality.
  • In Vivo Usage: Customized CMC service package for in vivo plasmid application such as DNA vaccine.

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