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Goodwin completes late-stage clinical expansion

By Kirsty Barnes, 07-May-2008

Related topics: Industry Drivers, Contract services (outsourcing)

Goodwin Biotechnology has announced that it has finally completed the construction of its expanded manufacturing facilities, which were 10 years in the planning.

Via an investment from its parent company, Wallace Pharmaceuticals, the US biopharmaceutical contract manufacturing organisation (CMO) was able to afford the expansion, which will now allow it to scale up its operations to manufacture therapeutics for late-stage clinical trials.

As part of the expansion project at its Plantation, Florida facility, which started in 2006, Goodwin doubled its good manufacturing practice (GMP) production space and added a 200L and 500L stirred tank bioreactor train to its hollow fiber and perfusion capabilities.

Elaborating on its decision to invest in expanded capacity and compliance, Goodwin said it was "fuelled by the need to keep up with the growing needs of the industry to outsource biological manufacturing".

"A vast segment of the biotechnology industry is comprised of product R&D entities that have no wish or need to develop core competence in GMP manufacturing."

One particular "rapidly growing and important" service area that Goodwin offers its customers involves the conjugation of antibodies and recombinant proteins to various linkers to be used in radio-immunotherapy and the delivery of chemotoxins in small doses directly to the patients' cancer sites.

The firm said that it is one of only a few manufacturers "qualified to develop and perform this highly specialised procedure".

Indeed, as the biopharmaceutical industry matures and more and more biologic drugs are moving through research and development pipelines, new opportunities are being created for contract manufacturers that engage in the highly specialised area of biopharmaceutical production, as the manufacturing of biopharmaceuticals is an expensive, complex, and highly technical process in comparison to that of small molecules and investment in manufacturing capacity for biopharmaceuticals is a risky decision for most companies as product development timelines are lengthy and have a high probability of failure.

Goodwin is not the only biopharmaceutical CMO to have the idea of increasing capacity and capabilities to capitalise on this growing industry demand.

For example, Simon Saxby, the new chief operating officer (COO) of Cobra Biomanufacturing recently told Outsourcing-Pharma.com that the company is now pushing into the new and more lucrative area of commercial manufacturing on its viral vaccine production side of the business, as well as in to Phase III and eventually commercial scale manufacturing on its protein production side of things.

"There is a much bigger market potential for commercial manufacturing than research and development," he said.

In addition, Catalent Pharma Solutions has just announced an expansion of its bioreactor capacity in order to meet an increase in mammalian cell culture demand.

The US biopharma outsourcing services company said that its expansion will also more than double its present bioreactor capacity by 2009, with the addition of a 1,000 litre bioreactor train in its Middleton, Wisconsin facility.

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