Merger across Pacific to create mega biofacility

A merger between PacificGMP and Pacific Biopharma Group is to create one of the largest single-use biomanufacturing facilities in the US or China.

A new company, China Quantitative Biomedicine, will be formed by the merger, which is to build a 61,000 sq. m. contract manufacturing facility in Taizhou, China, for the production of therapeutic proteins.

This facility will use PacificGMP's single-use technology throughout the biomanufacturing process, which the company believes significantly reduces the cost of protein production.

Gary Pierce, chief business officer of PacificGMP, said: " We look forward to contributing to the development of a state-of-the-art biomanufacturing facility in China to address the growing demand for contract manufacturing services and the rise of the Asian market for protein therapeutics ."

It is anticipated that the facility will primarily manufacture proteins destined for the US and European market but it also places the company in a position to capitalise on rising demand in Asia.

The facility is due to be completed by the end of 2008 and will be the showpiece of China Medical City, a new 12 sq. km. life sciences focused science park, situated 2.5 hours outside of Shanghai.

Under the terms of the merger PacificGMP will receive funding to develop the Taizhou facility and ensure it is compliant with current good manufacturing practices (GMP) prior to audits by the US Food and Drug Agency (FDA) and the European Medicines Agency (EMEA).

Some funding will also be made available to expand PacificGMP's operations at its San Diego facility.

PacificGMP's facilities make as much use of disposable plastic technology as possible, as opposed to the reusable, stainless steel equipment traditionally used in biomanufacturing.

The company claims this enables it to manufacture products for preclinical and clinical trials in less time and at a lower cost.

These benefits are in part achieved by negating the need for cleaning of the vessels, which can be a lengthy process requiring skilled personnel.

PacificGMP also claims the process offers more flexibility, enabling the manufacturer to rapidly scale up from 1 litre to 15,000 litres with ease.

The company is only three years old but has big plans, with Pierce saying: " We believe a significant opportunity exists for global leadership in single-use contract manufacturing services. "