Our GMP Facility
Our 4000 square feet GMP facility is based in Uppal, Hyderabad. The facility includes:
- Eight ISO 7/8 Cleanrooms
- A total capacity of 1 million doses/year with the ability to increase to 10 million/year
Take your RNA sequence to a clinical trial in less than 2 years
In our quest to make rapid progress on our mRNA vaccines, while being scrappy, we ended up developing a true end-to-end process for translating mRNA ideas into clinics.
Every CDMO we talked to, told us it would take over a year and millions of dollars to get a single product into a clinic. So we built out our own GMP facility where we can take a concept into clinic in as little as 3 months.
When we tried to license lipids, we were told it would cost another round of millions, again something we did not have. So we ended up designing our own library of over ionizable lipids - over 400 of them and have tested over 80 of these. Another thing no one tells you is that the ideal LNP formulation is sequence dependent.
Talk about IND studies - how hard and expensive they are to figure out from scratch. Involves dealing with multiple CROs. We have done all of it now.
We now want to bring our learning and end-to-end expertise to everyone. We can take your sequence to IND in 2 years.
1. You hand over the protein sequence and target indication
2. We optimize the RNA sequence for expression, stability, encapsulation and scale-up
3. We test different lipids and formulations to go with your RNA sequence
4. You test the different mRNA-LNP samples we send you in your key assays
5. If a candidate meets your criteria, we initiate process development for scale up. If not, we go back to Step 4 for at most 3 iterations.
6. We conduct 3 pilot scale (typically 10 mg scale) runs demonstrating consistency of our process.
Our 4000 square feet GMP facility is based in Uppal, Hyderabad. The facility includes:
Email: contact@popvax.com