The production facility, which focuses on making final dosage forms of specialist cancer and other drugs, addresses the shortage of aseptic production facilities in the West Midlands region and other areas of the UK.
There is a pressing need in the region for aseptic facilities to support the preparation of pharmaceuticals with a short shelf life - particularly in the treatment of children. Mayne Pharma is one of the biggest suppliers of generic pharmaceuticals in the UK, and will be able to use the new unit to produce final dosage forms, including those that cannot be sterilised commercially.
"The provision of aseptic goods can be an issue for the NHS," said Aston University's John Marriott, who was in charge of setting up the cleanroom. He told In-Pharmatechnologist.com while some NHS units have their own production/compounding facilities, in many cases these are stretched to capacity.
Marriott said this was the first manufacturing unit in the UK that brings together university research with advanced pharmaceutical manufacturing techniques. The facility will be licensed by the UK Medicine and Healthcare products Regulatory Agency (MHRA) to handle a range of orders, from an individual patient's dose to bulk items.
In essence, the partnership allows Mayne and the University to share the cost of the facility, which runs into the millions of pounds, as well as revenues, but there are additional benefits for both sides. Aston gets an invaluable, industry-oriented facility to complement its R&D and teaching functions, and Mayne will get the benefit of close contact with the university's research team.
Meanwhile, the NHS and private medical sector in the West Midlands - and nationally - should gain cost-savings by having improved access to finished products, reducing the amount of time doctors and other healthcare workers have to spend preparing doses themselves and, potentially, reducing medication errors.
R&D on stability, wastage
The supply of cytotoxic drugs for cancer, which often have short half-lives because they hydrolyse when reconstituted with water - also goes some way to set the research agenda at the university, said Marriott. This will focus in part on ways to improve and validate the stability of drugs, particularly so-called 'hot' items that need to be used within a matter of hours.
Another key area of research that will be undertaken alongside the new facility is into wastage. Marriott's group at Aston are in the final stages of working out just how much medicine is wasted through the discarding of unneeded material, and preliminary estimates suggest that nationally it could have a value in the hundreds of millions of pounds.
This is a particular issue in paediatrics, as children offer require a smaller dose than the unit amount supplied by pharmaceutical manufacturers, and the unused portion is discarded.
Producing final dosage forms at facilities such as the one at Aston could reduce this wastage, saving the NHS and potentially also the drug industry money. Final data from this ongoing study will be released in the next few weeks.
The clean room provides an ultra clean, sterile and controlled environment for pharmaceutical manufacture, research and teaching and will offer a complete specialist environment to support the development of new medicines.
Its rooms are temperature and humidity controlled to allow the aseptic production, manipulation and reconstitution of a variety of medical products (including chemotherapy drugs usually used in the treatment of cancer and individually tailored treatments for premature babies) that cannot be sterilised commercially.