Drug Substance (DS) Capabilities
x
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)
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
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.
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
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
