Our manufacturing facility has been designed to grow according to our customer needs.
Today we have four full cGMP process suites, one Sterile fill and finish suite and several preclinical and R&D labs equipped in 2.500 m² (15.000 sqr ft). We can expand up to 2.000 m2 (37.000 sqr ft).
We can work at several projects in parallel on their different stages: R&D, preclinical and clinical stage.
DNA manufacturing process, from miligrams to multi-grams, will be audited by regulatory agency in 03Q23.
ALL IN ONE SUITE
A.
All our rooms are provided with a 360º camera so as peroxidation system.
B.
Each production suite has an independent HVAC system, fully segregated to avoid any cross-contamination.
C.
The DNA is manufactured entirely, USP & DSP, in the cGMP Suite. We can work simultaneously in the different suites to fulfill the orders of several customers at micro, mili or gram scales.
STERILE FILL & FINISH
Fill & Finish suite is a Grade B clean room with a Grade A biosafety cabinet to perform the aseptic process for the sterile final product.
ADDITIONAL CAPABILITIES
We are continuously expanding our internal capabilities to compress time to market for our customers. R&D labs, preclinical suites so as functional testing enables us to develop and scale up tailored DNA.
Our production plant has additional 2.000 m2 ready to expand and increase current cGMP production capabilities to 12 suites, as well as to eight (8) additional non-GMP suites, without jeopardizing current manufacturing capabilities.
