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