Intellectivebio

Intellective Bio is a biopharmaceutical CDMO committed to accelerating your product development and commercialization. We efficiently use our modern infrastructure and cross-functional experts for R&D to large-scale production volumes from 1 to 210000 liters. Our multiple cGMP manufacturing plants, based in the biotech hub of Suzhou, China are optimized for commercialization in ICH-regulated markets including US, Europe, and China as well as other global territories.

Type of Drugs Manufactured:

Biologics

CDMO Services:

Drug Substance Manufacturing (API);Drug Product Formulation (FDF);Aseptic Fill Finish;Research & Development;Clinical Trials materials and logistics;Packaging;Regulatory Services;Analytical Development

No. of Manufacturing Facilities:

3-5

High Potent Products capabilities:

OEB >5

Facilities Locations:

China

Regulatory Approvals for facilities:

FDA (United States);EMA (Europe);ISO;GMP;NMPA (China)

Manufacturing Technologies:

Liquids;Lyophilized amps/vials;Pre-Filled Syringes (PFS)

Current Capacity:

Intellective Bio has established 8 drug substance production lines and 7 aseptic fill finish lines. Our Changshu site headquarters has built from greenfield a large-scale production plant with 8 manufacturing suites to address the traditional bottleneck of not enough purification capacity. Each manufacturing suite is capable of holding four 6000-liter stainless steel bioreactors, and each suite is serviced by its own downstream purification line. Each suite can be dedicated to no more than 10 to 12 products, providing our clients flexibility in scheduling to meet dynamic market forecasts.
At full operating capacity of 192 kiloliters from 32 6000-L bioreactors and 8 purification lines, we will be able to produce about 640 GMP batches per year.
This annual output is equivalent to close to 10 metric tons of formulated drug substance.