Isogen, a contract development and manufacturing organization for sterile filling, has retained a strategic financial partner to help it expand operations to meet the global biopharma demand for Isogen’s services. Isogen has previously announced a successful first round series of capital investment and the opening of its first filling line facility in Q1 2009 to deliver on the previously unmet process, facility and capacity needs of the $2 billion highly-niched, low-volume clinical and early-stage commercial sterile filling market segment. Pharmaceutical companies can invest over $100 million and four years to develop sterile manufacturing capacity, but are highly reluctant to take this initiative until they are certain the candidate drug will receive regulatory approval. Isogen will set a new industry standard for GMP-compliant clinical manufacturing and containment, enabling Isogen’s customers to plan and execute the supply of integrated sterile clinical and small scale commercial launches of single or multiple therapeutics at the same time while dramatically reducing costs and risks that are inherently associated with other in-house and outsourced alternatives. “Our initial-stage private financing, Delaware state government backing and follow-on funding will enable Isogen to be the best positioned firm to meet the pent-up demand in biopharma for the unmet contract filling, containment and quality standards, while significantly reducing sterile manufacturing capital costs and time-to-market for new drugs,” said Les Edwards, CEO, Isogen. Biopharma’s existing paradigm of spending hundreds of millions of dollars and waiting years to build additional sterile filling capacity to address clinical and commercial capacity needs of large pipelines no longer remains a viable option. Firms have few options to address these issues, and each solution presents significant drawbacks. Building new commercial sterile filling lines for clinical fills in-house is cost prohibitive. Large contract fillers have no financial incentive to service clinical volume-size projects, while small specialist clinical fillers lack the necessary expertise and equipment to adequately deliver against a pharmaceutical company’s complex needs. As a result, Isogen is the best positioned company on the market to address these unmet needs. Sheridan Road Financial will provide a path by which Isogen can ramp follow-on funding to expand its presence in the biopharma industry. “Isogen will help our customers address major industry dynamics that are reshaping the face and complexity of sterile clinical trials materials supply,” said Edwards. “Regulators in the U.S. and Europe increasingly require sterile clinical trials supplies to be manufactured in accordance with current Good Manufacturing Practice (cGMP) standards. At the same time many new pipeline drugs moving into clinical trials are potent compounds and require Isogen’s unique barrier isolation containment technology. Our process ensures safe manufacturing, while meeting strict global regulatory standards,” Edwards concluded.
