The manufacturing facilities at the Chemical GMP Synthesis Facility are designed specifically to handle the synthesis of APIs for phase I and phase II clinical trials. The manufacturing rooms are organized into three isolated, independent suites. The organic synthesis labs are specifically equipped to handle multigram to kilogram (phase I) and multikilogram (phase II) small molecule projects. The RNA/oligonucleotide laboratory suite is designed to accommodate production of cGMP-grade biopolymers (siRNA-aptamers, DNA-peptide hybrids, peptides).
Phase I Laboratory
The Phase I suite is equipped with three 6-foot walk-in fume hoods. Reactions are carried out in dedicated Chemglass jacketed glass reactors, with capacities from 500 milliliters to 20 liters. Purifications are carried out using an automated Teledyne Isco Torrent purification system, allowing for quick and efficient isolation of intermediates and final products.
Phase II Laboratory
The Phase II suite is equipped with two 8-foot walk-in fume hoods. Reactions are carried out in dedicated Chemglass jacketed glass reactors, with capacities from 20 to 100 liters. Purifications are carried out on a Biotage Flash 150 system, allowing for quick and efficient isolation of intermediates and final products.
The RNA/oligo laboratory has the ability to be equipped with the necessary synthesizers and purification equipment suitable for API manufacturing. Drugs in this category will be synthesized as lyophilized powders and processed in our Packaging/Purification Room using a VirTis Genesis 25EL Pilot Lyophilizer.
This room is dedicated to single product packaging prior to transfer of APIs for release testing and clinical use.
This room is equipped with Norlake ICH chambers, a Caron photostability chamber and controlled temperature storage (2-8ºC, -20ºC) for analysis of stability and bulk storage of API.