Drug Substance (DS) Capabilities

Microbial Drug Substance

Located at Chicago, microbial DS Suite(s) uses proprietary, SUB for DS manufacturing
Facility audited by FDA, ex-FDA auditors and business partners
Equipment train of 10 L and 250 L bioreactor(s)

Mammalian Drug Substance

Located at New Jersey
Designed for process scale-up for manufacturing of pre-clinical batches
Equipment train of 5 L to 50 L
200 L Facility for Clinical & Commercial Batches

Drug Product Manufacturing Facilities

DP facility at Chicago for Vial & PFS
DP expansion facility at New Jersey
State of art, qualified PFS filling line from Optima pharma GmbH
Aseptic Fill-Finish Operation using SUT.
Annual capabilities of > 6.5 Million units.

Testing & Secondary Packaging

State of art biochemical, and microbiology laboratory
Capable of inhouse release and stability testing of DS, DP, process related, protein related impurities & in vitro bioassay.
Secondary packaging capability along with Syringe Labeling, Plunger and Safety Device assembly and serialization

World Class Quality & Accuracy
by Professional Experts