Personalized Batches

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

Fast-track Manufacturing

Personalized vaccines are novel and exciting therapeutic approaches in current clinical development. In particular, DNA vaccines based on patient-specific tumor-antigens – so-called “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 logistics and effectiveness to provide the patient-specific vaccine in a short period of time. Biomay has developed a highly efficient platform process for manufacturing of patient-specific plasmid DNA vaccines.

Patient-specific Platform

Concept of personalized plasmid manufacturing by Biomay:

  • Patient-specific DNA plasmid is delivered by client
  • Incoming testing
  • Cell banking
  • GMP manufacturing drug substance
  • GMP manufacturing drug product (optional)
  • Quality control and QP release
  • Shipping plasmid to client or clinical center

Special features of Biomay's personalized manufacturing platform:

  • From incoming of start plasmid to release drug substance within a few weeks
  • Full GMP with QP release
  • Target amount: several 100 mg
  • Dedicated manufacturing area / parallel cleanroom suites
  • Mainly single-use equipment