Our Biopharmaceutical Model
Though more and more biopharma companies are emerging with biosimilars and biologics, biopharmaceutical manufacturing processes for their production have been practically devoid of any innovation. This stagnation is predominantly caused by necessity for, speed to market, regulatory compliance, and ease of equipment selection for industry standard, bioprocess design. Given the upward trends in present and future biopharmaceutical development, the need for the innovation of process technologies is evident.
The biopharmaceutical industry leaders have adopted similar manufacturing processes, irrespective of cost, for the production of biologics (e.g. monoclonal antibodies) to enable speed to market, to capitalize on industry knowledge, and to ensure regulatory compliance.
As biosimilar manufacturers emerge, the necessity to achieve parity on purity and efficacy at a lower price point is evident. The necessary cost reductions are derived from increased yield, increased throughput, lower CapEx, and lower OpEx with respect to the manufacturing line. These cost reductions will only be attained through process innovations.
Develop de novo, paradigm-shifting biopharmaceutical process technologies to enable simple, low cost production of biosimilars and biologics that manifest high throughput, high purity and controlled efficacy.
Approach biopharmaceutical manufacturing processes as if the industry standard process design and process equipment did not exist. Develop cell culture methods tailored specifically for the desired cell line expression system. Design and fabricate de novo downstream process equipment to streamline protein purification, isolation, and concentration into fewer process steps and to enable higher throughput, purity and yield from a smaller facility footprint.
Utilize these biopharmaceutical manufacturing process innovations to produce safe and effective, low cost biologics and biosimilars for immunotherapeutic approaches in the treatment of chronic diseases.