Biopharmaceutical companies have to take many variables into consideration when bringing a product to market. If they are working with several CMOs, they will likely encounter problematic inefficiencies like wasted time, information loss, and redundancy of service, all of which can delay the delivery of products to patients.
A Unique Model
To help address these concerns, Cook Pharmica developed a unique solution: the “one-source, one-location” model. This model makes it possible for biopharmaceutical companies to work with a single CMO through all phases of a project. Centrally located in the United States in Bloomington, Indiana, Cook Pharmica is a 900,000 square foot, state-of-the-art facility large enough to accommodate everything from development to biologics manufacturing and filling, finishing, and packaging.
As part of the one-source, one-location model, Cook Pharmica has development capabilities that include an upstream lab with 2 L, 5 L, and 20 L systems, a scale-up lab with systems up to 250 L, a downstream lab with chromatography and tangential flow filtration systems, and an analytical laboratory with full bioanalytical capabilities. Cook Pharmica also features a formulation lab to support the development and optimization of both liquid and lyophilized formulations.
Drug Substance Manufacturing
To address the tremendous growth of the biologics market, Cook Pharmica has built a facility capable of handling a variety of needs. Its bulk drug substance manufacturing capabilities include two GMP production areas that can support both clinical and commercial mammalian cell-culture manufacturing projects.
Upstream manufacturing includes multiple single-use reactors, a 600 L stainless steel seed tank and two 2,500 L stainless steel production bioreactors. Downstream manufacturing includes two 3,500 L harvest tanks, depth filtration, centrifugation, tangential flow filtration, and multiple chromatography systems and columns. Upstream manufacturing in the small-scale production area includes 10 L and 25 L single-use wave reactors along with a 250 L single-use, stirred-tank production bioreactor.
Drug Product Manufacturing
Flexible facility and process design, along with state-of-the-art equipment, allows the Cook Pharmica parenteral drug product manufacturing facility to handle both commercial- and clinical-scale formulation and manufacturing for liquid vials, lyophilized vials and syringes, all of which are accompanied by inspection, labeling, and packaging services.
The syringe line can process up to 600 syringes per minute, or approximately 70 M units per year, and is capable of handling a wide array of batch sizes. And the filling line is fully enclosed in a barrier isolator. After the filling process, syringes can be manually or automatically inspected and labeled, and can be bulk or custom packaged for either commercial or clinical use.
The vial line can process up to 150 vials per minute, or approximately 15 M units per year, and the vial line is also capable of handling a wide array of batch sizes. Filling, stoppering, lyophilization in a 250 square foot lyophilizer and capping are all performed in a fully enclosed barrier isolator. Vials can be inspected, manually or automatically labeled and bulk or custom packaged for either commercial or clinical use.
The Advantage of One Point of Contact
Cook Pharmica’s unique one-source, one-location model helps biopharmaceutical companies simplify their contract manufacturing by having development, drug substance and drug product services all in one location, with one point of contact and one set of business practices. Providing services from DNA to packaging, Cook Pharmica can increase economic value, improve manufacturing efficiency, mitigate risk, and accelerate the delivery of life-enhancing discoveries to patients worldwide.