Isogen plant to answer small-scale sterile filling need

The sterile process engineering consultancy first announced it would start up its own manufacturing operations back in April, in order to plug what it said was a major gap in injectable manufacturing.

Isogen CEO Les Edwards said that the firm had “spotted a huge gap in the market for injectable contract manufacturing to fill small lots of material or clinical materials, and we decided to fill this gap​."

Isogen said the Phase I facility will address “the process, facility and capacity problems commonly associated with the $2bn highly-niched, low-volume clinical and early-stage commercial sterile filling market segment.​”

Isogen's facility will provide Good Manufacturing Practice (GMP) vial and syringe filling, ranging in fill size up to 4,000 units per shift in fully segregated, isolator-based fill lines in a potent capable facility. Isolator-based lyophilisation capacity is planned for later in 2009.

“Companies can invest over $100m 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​,” according to Edwards.

Large contract fillers have focused on commercial filling, which is more lucrative, while smaller players often lack the breadth of expertise needed to service the complex needs of biopharmaceutical companies.

Isogen will be using barrier isolation technology in each of the seven manufacturing suites in the plant "to provide best-in-class sterile processing for potent and non-potent compounds​," he said.

Isolator technology won the endorsement of the technology by the European Medicines Agency in May 2003, and the US Food and Drug Administration (FDA) in September 2004, as a suitable technology for use in aseptic manufacturing. The high capital cost of installing isolators can be set against the high operational costs of running cleanrooms.

"Regulators in the US and Europe increasingly require sterile clinical trials supplies to be manufactured in accordance with cGMP standards​, he said.

Isogen will offer an integrated GMP clinical and early commercial contract filling service comprising sterile process development, analytical laboratory services and pharmaceutical engineering consulting.