March 12, 2008 — /PRNewswire/ — PHILADELPHIA, PA — Isogen announced it will introduce new solutions to address the pharmaceutical industry’s long-standing process, facility, and capacity problems associated with the low-volume clinical and early-stage commercial sterile filling market at INTERPHEX 2008. Isogen participates in the parenteral dose contract manufacturing sector, which comprises a $2 billion segment of the overall $40 billion pharmaceutical industry outsourcing market. Pharmaceutical companies are confronted with fundamental constraints that directly impact issues of time-to-market and patient access to life saving drugs. The existing paradigm of spending tens or hundreds of millions of dollars and waiting years to build additional sterile filling capacity to address the clinical and early commercial capacity needs of large pipelines, including many orphan drugs, is exacerbated by the need to cope with the potential instantaneous skyrocketing capacity demand for drugs and vaccines associated with future pandemic or bioterrorism events.
Pharmaceutical firms have few viable 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.
“Isogen was founded to specifically address the process, facility, and capacity problems commonly associated with the highly niched, low volume clinical and early stage commercial sterile filling market segment,” says Isogen CEO and co-founder Les Edwards. “Companies can easily spend upwards of $100 million and expect to take at least 4 years to develop sterile manufacturing capacity, but they are highly reluctant to do this until they are certain the candidate drug will receive regulatory approval. Isogen will accommodate vial, syringe, or lyophilized vial fills ranging from a few hundred to tens or hundreds of thousands on the same equipment, with common validation and document packages, while setting new industry standards for sterility and containment assurance,” says Edwards. “As a result, Isogen enables customers to plan clinical and market 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,” adds COO and co-founder Austin McDonald.
“With significant help from Delaware and New Castle County government leaders, Isogen’s new facility will be functional in 2009 and be fully operational early in 2010,” says McDonald. “Isogen’s outsourced processes and infrastructure will provide rapid, reliable sterile filling solutions for small clinical through early commercial batches using proprietary formulation, validation, and filling equipment standards and practices in dedicated advanced barrier isolation environments.”
Isogen leverages proprietary state-of-the-art barrier isolation technology to provide best-in-class sterile processing for potent and non-potent compounds. Isogen facilities feature multiple standalone filling suites for liquids and lyophilized products in batch sizes from a few hundred to 30,000 vials or 100,000 syringes. Isogen’s world-class technical team provides support services for sterile fill operations including formulation, technology transfer, validation studies, and regulatory submissions.
Isogen is the leader in advanced sterile manufacturing for potent and non-potent therapeutics for the critical clinical/commercial scale manufacturing transition. Isogen provides a fully integrated suite of services including formulation, technology transfer and validation services for the contract filling of liquids, and lyophilized formulations for vaccines, mAbs, and other synthetic and biologically derived therapeutics. Isogen delivers critical full service resources to pharmaceutical and biopharmaceutical manufacturers seeking solutions in advanced sterile filling including clinical and transitional contract filling, formulation/validation based analytical laboratory services, and advanced sterile fill line/equipment design and GMP project management.