A licence to manufacture medicines (2012)
A licence to manufacture medicines has been granted to a University of Auckland facility that will produce the active ingredients of cancer vaccines to be tested in humans. The facility will contribute to vaccine programmes that involve Maurice Wilkins Centre investigators around the country.
Two years of work, completed in 2012, has transformed a standard chemical laboratory
into a state of the art facility that will produce the active ingredients destined for human
clinical trials.
The new laboratory, which meets stringent international good manufacturing
practice (GMP) standards, reflects the Maurice Wilkins Centre’s commitment to taking
its technology into manufacturing platforms. The first clinical trial it will service is an
experimental treatment for melanoma, but the facility will be used for a range of clinical
trials in the future.
GMP manager Sarah Carley (pictured below) worked alongside lead chemist Dr Geoff Williams (pictured below) to develop
the manufacturing systems that were inspected by Medsafe, New Zealand’s regulatory
body controlling new medicines, before the licence was granted. Every component and
procedure was painstakingly tested, documented, and approved, from the raw materials
used by the chemists to the air they work in.
The new laboratory complements a GMP facility at Callaghan Innovation’s Gracefield
campus, where an “adjuvant” or booster for the vaccines will be produced, and a GMP
cell therapy facility at the Malaghan Institute of Medical Research.
Real New Zealand Inc story
In the first clinical trial, vaccine components from Auckland and Gracefield will be soaked into patients’ own
immune cells at the Malaghan Institute before being administered.
“This is a real ‘New Zealand Inc.’ story,” says Maurice Wilkins Centre principal investigator Professor Margaret
Brimble, who led the establishment of the laboratory, along with Centre Director, Professor
Rod Dunbar.
Margaret is a renowned chemist who specialises in producing synthetic copies of compounds found in nature. Her team’s role in the first clinical trial is to synthesise peptides (short sections of protein) that mimic those on cancer cells. The peptides – the vaccine’s active ingredients – are designed to help the immune system learn to recognise and eliminate cancer.
Unlike traditional vaccines, cancer vaccines are given after the disease has developed.
Their relative lack of side effects allows them to be added to standard cancer therapies.
The first vaccine to be tested will use patients’ immune cells as carriers but in future they
are likely to be administered directly, for example by injection into the skin.
The first clinical trial has been funded by a $4.5 million programme grant from the Health
Research Council, linking immunologists, chemists and cancer specialists. The initial focus
is on melanoma but project leader Dr Ian Hermans from the Malaghan Institute says the
techniques being developed also have the potential to be used in other cancers: “Many
cancers respond to immune activation, so an effective vaccine-based strategy with a good
safety profile could alleviate suffering on a large scale.”