GMP-Grade Plasmid DNA Vectors

 

Innovative Contract Manufacturing Solutions for DNA for Advanced Therapies

  • pDNA as drug substance (API) for gene therapy or DNA vaccination
  • pDNA as starting material for viral vector manufacturing (e.g. AAV)
  • pDNA as vectors for cell therapy
  • pDNA as template for mRNA transcription
  • pDNA as template for siRNA or miRNA transcription

 

Producing Plasmids for Vaccination and Therapy

Biomay is a CDMO for manufacturing of pharmaceutical plasmid DNA (pDNA). In this field, Biomay is specialized in the GMP-conform supply of highly pure pDNA for clinical phases I - III, with batch sizes ranging from 50 mg to 10 gram. Biomay´s plasmid DNA manufacturing technology is completely large-scale compatible and comprises the following features:

  •   Robust, reliable and proven process design
  •   High-yield E. coli  hosts
  •   High-cell density cultivation (25 L bioreactor)
  •   Optimized media (no antibiotics or animal compounds)
  •   Scalable alkaline lysis
  •   High-quality purification (up to 98 % supercoiled)
  •   Suitable for personalized (patient specific) batches

 

Quality and Specifications of pDNA

Parameters                              Specifications | Assay

DNA concentration                     0.5 – 5 mg / mL | HPLC / UV

DNA homogeneity                      up to 98 % sc | HPLC

DNA identity                             100 % restriction / sequence

Endotoxins                                < 1 EU / mg pDNA | LAL test

Host cell protein                        < 10 µg / mg | BCA / ELISA

Host cell DNA                            < 10 µg / mg | qPCR

Host cell RNA                            < 10 µg / mg | agarose gel

Bioburden (sterility)                  0 CFU / mL membrane filtr.

Biomay – a CDMO with a Strong Plasmid Network

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

  •   Vector design and cloning
  •   GMP cell banking
  •   Process and analytical development
  •   GMP manufacturing drug substance / start material
  •   GMP aseptic filling drug product (subcontracted)
  •   Tailored enzymatic processing & linearized vectors
  •   QP release and regulatory support
  •   ICH stability testing & long-term storage

Biomay´s technology offers scalability, comparability, high yield and attractive pricing throughout the whole development chain. In addition, a broad network of subcontractors widen Biomay´s options of CDMO services for pDNA.

 

If you have questions or would like to have a quote for pDNA services, please send an e-mail to request(at)biomay.com.