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
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