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Avecia bundles formulation studies with biologics services

By Phil Taylor, 17-Jun-2008

Related topics: Materials & Formulation, Contract services (outsourcing), Processing (automation, control, separation)

UK biotechnology group Avecia Biologics has set up a new formulation studies team to support the activities of its contract manufacturing and process development operations.

The new unit, based at Avecia's Tees Valley facility, extends the range of services Avecia can offer to its customers, and is expected to appeal mainly to smaller biotechnology companies that do not have the knowledge or resources to carry out this kind of testing in-house. Last year the firm set up a stability studies group with a similar rationale.

Dr Stephen Taylor, business director at Avecia, said there is growing recognition that formulation studies should be started as early as possible in the development of a new biologic drug in order to save time and money later on.

The consequences of inappropriate formulation selection can be very expensive in terms of both time and money, he warned.

"If it means that initial clinical studies have to be repeated, then the consequences can be up to six months delay in a programme," said Taylor, adding: "That could equate to millions of wasted dollars."

Doing formulation studies early in the development life of a product allows the maximum benefit to be gained from clinical studies and reduces the risk of a product failing to deliver its expected effect.

"Those failures can fundamentally undermine the success of early-stage biotechnology companies," said Taylor.

The unit will bring together the biochemical, bioanalytical and biophysical techniques needed to ensure the formulation of protein-based drugs is optimal.

"Compared to small molecules, proteins tend to behave unpredictably," said Taylor. "Subtle changes in the production process can influence the behaviour of a protein in a formulation, for example causing aggregation which can affect therapeutic performance."

Biologic drugs are generally supplied in liquid forms, and it is also important to test whether the formulation stands up to the freezing and thawing that may be required before the medicine can be delivered to patients.

Laboratory space has been set aside for the new group, and additional staff will eventually be recruited, although initially Avecia will draw on existing members of its 120-strong R&D staff to operate the service.

"The group builds on the collective knowledge and experience at Avecia over the past 10 years," said Taylor. "This is an extension of our process development and manufacturing knowledge. The close link between process and formulation ensures the impact of inevitable process changes on formulations can be understood and quickly addressed."

Taylor also believes this close association will shorten the development timeline of a biologic drug through to the clinic.

At the moment the service is focussing on Avecia's biologics business, although it may be extended to the firm's other pillar - oligonucleotide medicines - in a second stage.

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