Personalized Manufacturing

We supply personalized and patient-specific plasmid DNA batches in GMP-quality – within a few weeks.

Patient-specific Plasmid Platform

Personalized vaccines is a novel therapeutic approach in current clinical development. In particular, DNA vaccines based on patient-specific tumor-antigens (neoantigens) are a promising solution to cure cancer patients.
The concept of personalized DNA vaccination –with individual cancer patients awaiting their treatment – require radically new approaches with respect to manufacturing logistics and effectiveness to make the vaccine in a minimal period of time.

Biomay operates a highly efficient platform process for manufacturing of patient-specific plasmid DNA vaccines. We have meanwhile an extensive track record, with more than 100 personalized pDNA batches manufactured and released.

Summary of Biomay's personalized plasmid manufacturing platform:

  1. Incoming testing of start plasmid (from client)
  2. Patient-specific cell banking
  3. GMP manufacturing drug substance (5 L bioreactor scale)
  4. GMP manufacturing drug product (aseptic filling)
  5. Quality control and QP release
  6. Shipping plasmid to client or clinical center.

Special features:

  • From incoming of start plasmid to release of DS/DP in four weeks
  • Fully GMP-conform from scratch, including QP release
  • Target amount: x 100 mg per patient
  • Dedicated manufacturing suites: 4 x upstream / 4 x downstream
  • Applicable for linear DNA templates for IVT of personalized mRNA
  • Mainly single-use equipment for rapid turnover
  • More than 100 batches track record