Plasmid DNA

Plasmid DNA is our core competence – whether circular or linearized, big or small. With more than 200 GMP-manufactured plasmid batches, our track record is strong.

Core Competence: pDNA

Comprehensive expertise in pDNA manufacturing:

Biomay has been a specialized GMP plasmid manufacturer since more than 15  years. As a service provider, we put high strategic priority on plasmid DNA. Biomay has a deep scientific understanding and a profound problem solving capacity in any context of plasmid manufacturing and testing.
Biomay’s plasmid technology offers scalability, high purity and a high yield throughout the whole product life cycle (from clinical phases I-III to sustained market supply).

Extensive track record in the numerous pDNA products:

  • Aseptically filled drug product for gene therapy and DNA vaccination
  • Bulk drug substance (API) for gene therapy and DNA vaccination
  • Plasmids as critical starting material:
    • Viral gene therapies (starting plasmids for adeno-associated viral / AAV vectors)
    • Viral cell therapies and CAR-T (starting plasmids for lentiviral / LV vectors)
    • mRNA vaccines (linear DNA templates for in-vitro transcription)

Technical features of Biomay's proprietary plasmid platform

  • Generic and universal platform for manufacturing and testing
  • Full scalability and flexibility: from 100 mg to 100 g pDNA per batch
  • Wide range of bioreactor capacities: 3L, 30L, 50L, 150L and 750L
  • Well suited for big plasmids up to 20 kilo-base pairs
  • Enzymatic linearization (DNA template for mRNA IVT)
  • Fast track supply of personalized pDNA
  • Process free of animal components, antibiotics, organic solvents
  • Generic quality control methods for circular and linear DNA
  • High quality, purity and homogeneity (% supercoiled)
  • High throughput: from gene to product in 6 months

As a one-stop shop CDMO, Biomay offers following plasmid services:

  • Plasmid design and construction
  • Process development / feasibility studies
  • Analytical development / validation of QC methods
  • cGMP cell banking (MCB/WCB plus testing, release, storage)
  • cGMP production of circular DNA plasmids
  •  cGMP production of linear DNA templates for mRNA in-vitro-transcription
  • cGMP aseptic filling of drug product (automated or manual)
  • QC testing, QP release and regulatory support
  • ICH stability testing & long-term storage

Analytical assays for circular pDNA and linear DNA (GMP Quality Control):

General Parameter
pDNA-specific Parameter
pDNA-specific QC assay
Sanger sequencing
Integrity / homogeneity
Restriction digest & agarose gel electrophoresis
General purity
Purity / product related
Homogeneity / % supercoiled pDNA
Impurity / process related
Host cell DNA
Impurity / process related
Host cell Protein
Impurity / process related
Host cell RNA
Chromogenic LAL (Ph.Eur. 2.6.14 D)
Bacteria, yeasts, molds (Ph.Eur. 2.6.12/ USP<61>)
Sterility (Ph.Eur. 2.6.1 / USP<71>)
Linear DNA in addition:
Poly(dA:dt) integrity
Restriction digest & PAGE
Purity / product related
Linearization efficiency
Agarose gel electrophoresis

Related Services

From sequence to product

Biomay is your one-stop-shop for GMP manufacturing services.