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:
- Incoming testing of start plasmid (from client)
- Patient-specific cell banking
- GMP manufacturing drug substance (5 L bioreactor scale)
- GMP manufacturing drug product (aseptic filling)
- Quality control and QP release
- 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
