Manufacturing Facility
PlasmaGen’s manufacturing plant for plasma-derived protein therapeutics is envisioned as a state-of-the-art facility that will cater to the regional demand. The facility is a greenfield project located in the Vemagal Industrial Area, Kolar (near Bengaluru) on approximately 8 Acres. The total facility will be spread across multiple connected, yet independently operable blocks that support individual operations of the manufacturing process. These blocks will independently house manufacturing, fill finish, warehouses, plasma testing, R&D and support functions respectively.
The fractionation plant has an initial designed capacity for fractionating two hundred thousand litres of plasma and will be expandable. The facility is planned for the production of multiple plasma products comprising normal Human Immunoglobulin, Human Albumin, and coagulation factors. Provision for addition of more products has been incorporated into the design, allowing PlasmaGen to expand its product portfolio as required.
Process and Process Technology
PlasmaGen’s facility is going to house a process based on a much improved and optimized variation of the original Cohn’s fractionation process.
The technology backbone for plasma fractionation has remained more or less same since its inception in the late 1940’s, with continuous optimization and improvements being incorporated while adhering to the original scientific principle of fractionation. These have resulted in the use of multiple variations of the same process in operation across the world but resulting in higher yield of products that are have higher purity and are almost infinitely more safer than the products that were obtained from the original process.
The technology being put to use in PlasmaGen’s plant promises higher than conventional yields of very high-quality product along with impeccable safety.
Plant Design
The facility is designed optimally to suit process requirements with clear segregation of individual areas as per regulatory and cGMP norms. Total clean room environment with required grades is maintained to suit the individual manufacturing steps.
The design of the entire plant complex has been carried out keeping in mind the strategic aspects of the project from both commercial and implement ability aspects. Multiple design factors create a value proposition for stakeholders as well as partners in the value chain.