Personalized Manufacturing
Biomay offers GMP manufacturing of personalized and patient-specific DNA and mRNA cancer vaccines – within a few weeks.
Patient-specific Manufacturing Platform
Personalized cancer immunotherapy is a novel approach in current clinical development. In particular, personalized DNA and mRNA vaccines based on individual patient’s tumor-antigens (neoantigens) have recently shown clinical breakthrough results.
GMP manufacturing of personalized vaccines – with individual cancer patients awaiting their treatment – require shortest turnaround times, GMP process excellence and a reliable supply chain.
Biomay offers a highly efficient platform for personalized manufacturing of patient-specific mRNA and plasmid DNA vaccines. Our extensive track record includes a positive outcome of a Phase I/II clinical study with 120+ GMP batches of a personalized neoantigen cancer vaccine.
mRNA from starting material in as little as three weeks
Summary of Biomay's personalized mRNA-LNP manufacturing platform:
- In-silico sequence of individual patient mRNA provided by sponsor
- DNA fragment synthesis = starting material (external)
- Incoming testing of patient-specific DNA fragmental center.
Our process starts after having received and tested the individualized starting material.
- Cloning into backbone construct and patient-specific cell banking
- Template DNA manufacturing and linearization
- GMP mRNA manufacturing and formulation in LNP
- Aseptic filling
- Quality control and QP release
- Shipping personalized mRNA to sponsor or clinical center.
Special features:
- From incoming of starting material to released mRNA-LNP in three weeks
- Fully GMP-conform from scratch, including QP release
- Target amount – up to 50 mg mRNA per patient
- High batch-to-batch consistency
- 10 segregated GMP clean room suites
- Single-use equipment for rapid turnover
- In-house QC and aseptic filling
- In-house rapid sterility testing
Plasmid DNA from starting material in as little as two weeks
Summary of Biomay's personalized plasmid manufacturing platform:
- In-silico sequence of individual patient DNA provided by sponsor
- DNA fragment synthesis = starting material (external)
- Incoming testing of patient-specific DNA fragment
Our process starts after having received and tested the individualized starting material.
- Cloning into backbone construct and patient-specific cell banking
- GMP manufacturing and purification
- Aseptic filling
- Quality control and QP release
- Shipping plasmid to sponsor or clinical center.
Special features:
- From incoming of starting material to released plasmid DNA in two weeks
- Fully GMP-conform from scratch, including QP release
- Target amount – up to 300 mg DNA per patient
- High batch-to-batch consistency
- 10 segregated GMP clean room suites
- Single-use equipment for rapid turnover
- In-house QC and aseptic filling
- In-house rapid sterility testing
