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):
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General Parameter
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pDNA-specific Parameter
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pDNA-specific QC assay
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|---|---|---|
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Identity
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Sequence
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Sanger sequencing
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Identity
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Integrity / homogeneity
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Restriction digest & agarose gel electrophoresis
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Content
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UV260
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Purity
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General purity
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UV260/280
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Purity / product related
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Homogeneity / % supercoiled pDNA
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AEX-HPLC
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Impurity / process related
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Host cell DNA
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qPCR
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Impurity / process related
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Host cell Protein
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BCA
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Impurity / process related
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Host cell RNA
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Ribogreen™
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Safety
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Endotoxin
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Chromogenic LAL (Ph.Eur. 2.6.14 D)
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Safety
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Bioburden
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Bacteria, yeasts, molds (Ph.Eur. 2.6.12/ USP<61>)
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Safety
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Sterility
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Sterility (Ph.Eur. 2.6.1 / USP<71>)
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Linear DNA in addition:
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Identity
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Poly(dA:dt) integrity
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Restriction digest & PAGE
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Purity / product related
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Linearization efficiency
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Agarose gel electrophoresis
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Related Services
From sequence to product
Biomay is your one-stop-shop for GMP manufacturing services.
