Avecia, Europe's largest privately-owned speciality chemicals company, has scored a world first with the certification by all European Union member states of its DNA medicines production facility at Grangemouth, Scotland.
The facility is the only plant in the world certified to make DNA active pharmaceutical ingredients (APIs) to GMP standards for clinical trials and launched products, according to the company.
A spokesman for the company told In-Pharmatechnologist.com that the certification is an important recognition of Avecia's capabilities in this area and will serve as a key differentiator for the company in the marketplace for DNA medicine manufacturing, although it does not represent an extension of the company's capabilities.
The certification follows a successful inspection of the facility by the UK's Medicines and Healthcare Regulatory Authority (MHRA), which has EU-wide recognition. The MHRA audit has now validated Avecia's quality systems and facilities for production of both clinical trial and launched product quantities.
"MHRA certification means that APIs supplied by Avecia from its Grangemouth DNA facility meet all current and potential future requirements described in the EU's new Clinical Trials Directive", said the company in a statement. They will also meet the requirements of the new Annexe 18, contained in the draft amendment of 2001/83/EC, covering medicinal products for human use, it added.
Avecia is already the world's largest manufacturer of DNA medicines and is planning further development of its facilities in both Grangemouth and Milford in the US. The two manufacturing have a combined capacity of almost 600 kg/year.
In late 2002, Avecia signed a five-year agreement with Genta of the US for the manufacture and supply of the oligonucleotide API for Genasense (oblimerson sodium), a drug for malignant melanoma that is currently in Phase III trials and partnered with Aventis.
Genasense is one of several DNA-based medicines approaching launch. There are over 40 in clinical trials and another 200 in preclinical development, according to Avecia.