Manufacturing of Plasmids and DNA Vaccines
Biomay manufactures GMP-grade plasmid DNA (pDNA) for gene vaccination and gene therapy for third parties and for its own clinical pipeline (allergy treatment). Biomay is specialized in GMP-conform supply of ultrapure pDNA for early clinical phases. Common plasmid batch sizes range from 100 mg to 5 g.
Plasmid Technology and Services
Biomay has entered a collaboration including the transfer and establishment of Boehringer Ingelheim´s plasmid DNA manufacturing technology for GMP-grade plasmids. The production process established at Biomay is well proven, completely compatible with large-scale, and comprises the following features:
- High-yield E. coli hosts
- High-cell density cultivation (25 L bioreactor)
- Synthetic media (no antibiotics, no animal compounds)
- Scalable alkaline lysis
- High-performance downstream process
- Highly homogenous pDNA (up to 98 % supercoiled)
Biomay offers the following pDNA manufacturing services:
- Plasmid design and cell banking
- Process and assay development
- Manufacturing of plasmids in GMP and non-GMP quality
- Aseptic filling of drug substance (API)
- Aseptic filling of drug product (outsourced to sub-contractor)
- Qualified person batch release of pDNA drug product
Drug substance plasmid DNA of high purity and homogeneity (HPLC and agarose gel)
Plasmid Quality Control and Specifications
Biomay´s service offering is dedicated to high GMP standards. The quality features and specifications of Biomay´s pDNA are summarized as follows:
- pDNA concentration: 0.5 – 5 mg / mL (HPLC / UV)
- pDNA homogeneity: up to 98 % supercoiled (HPLC)
- pDNA identity: 100 % conformance in sequence and restriction map
- Endotoxins: < 1 EU / mg pDNA (LAL assay)
- Host cell protein: < 10 µg / mg pDNA (BCA / ELISA)
- Host cell DNA: < 10 µg / mg pDNA (qPCR)
- Host cell RNA: < 10 µg / mg pDNA (agarose gel electrophoresis)
- Bioburden: < 1 CFU / mL (membrane filtration)
Boehringer Ingelheim – A Strong Partner in Plasmid DNA
Via a technology transfer agreement, Biomay makes the innovative Boehringer Ingelheim plasmid DNA manufacturing technology accessible to early-stage clients, who require small amounts of GMP-grade plasmid. Biomay´s collaboration with Boehringer Ingelheim RCV GmbH & Co. KG (Vienna) offers a comprehensive contract service solution for mg to several g quantities provided by Biomay, and for g to kg pDNA quantities supplied by Boehringer Ingelheim.
Boehringer Ingelheim is a pioneer and a global leader in pDNA manufacturing. Biomay´s technology cooperation with Boehringer Ingelheim enables the uninterrupted supply of plasmid DNA products from early clinical development to commercial production. The collaboration offers scalability, comparability, a high yield and attractive pricing throughout the whole development chain of plasmid based biopharmaceuticals.
Links and Downloads:
Press release Feb 1, 2010
Boehringer Ingelheim Biopharmaceuticals
PDF Flyer Biomay Plasmid Services
PDF Folder Boehringer Ingelheim Plasmid DNA Manufacturing
NEWS
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