The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has given the therapeutic antibody specialist's facilities the approval to manufacture biological investigational medicinal products (IMPs) to be used in clinical trials in the European Union. In addition, the MHRA certification positions Xoma to manufacture European investigational drugs on a contract basis for other organisations.

"This is part of our strategy for maximising the utilisation of our assets and driving the company to profitability," said Rob Tenerowicz, Xoma's vice president of operations.

Fundamental to the process for producing IMPs is the need to comply with the requirements of good manufacturing practice (GMP), which were modified two years ago and now include IMPs.

According to the MHRA, all manufacturers of IMPs used in clinical trials must now hold a manufacturer's authorisation.

The European directive 2001/10/EC was issued with the aim of harmonising the different rules and procedures for clinical trials throughout the EU.

Transposed into UK law under the Medicines for Human Use (Clinical Trials) Regulations 2004, these regulations aim to ensure that the safety of clinical trial subjects are protected by requiring sponsors of trials to be responsible for conducting clinical trials according to internationally recognised principles of good clinical practice.

At the root of the issue is the fact that the production of IMPs is much more complex in comparison to marketed products because of the lack of fixed routines, variety of clinical trial designs, consequent packaging designs, and the increased risk of product cross-contamination.

Furthermore, there may be incomplete knowledge of the potency and toxicity of the product and a lack of full process validation, or, marketed products may be used which have been re-packaged or modified in some way.

Under the regulations, manufacturers of IMPs have, for example, to conduct repeated self-inspections as part of the quality assurance system in order to monitor the implementation and respect of GMP.

In addition, they have to label IMPs to ensure protection of the subject and traceability and to enable identification of the product and trial product.

Xoma, which has a therapeutic focus that includes cancer and immune diseases, said the new certification was an important development since the company has a number of its own and partnered drugs in development that are candidates for clinical trials in Europe.