News sterile facility to support pharma industry’s capacity needs

Pharma companies are currently faced with the challenge of spending millions and waiting years to address the clinical and early commercial capacity needs of large pipelines, including many orphan drugs. But at the same time, they have to make allowances for the potential instantaneous capacity demand for drugs and vaccines associated with future pandemic or bioterrorism events.

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.

Isoggen aims to address this by developing a new facility that will ‘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,’ according to Isogen coo and co-founder Austin McDonald.

The facility will be functional in 2009 and will be fully operational in early 2010.

‘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,’ said Isogen ceo and co-founder Les Edwards. ‘Companies can easily spend upwards of $100m and expect to take at least four 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 lyophilised 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,’ said 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,’ added McDonald.

Isogen participates in the parenteral dose contract manufacturing sector, which comprises a $2bn segment of the overall $40bn pharmaceutical industry outsourcing market. The company 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.

These new solutions will be showcased at INTERPHEX 2008 from 26 to 28, March Pennsylvania Convention Center.