Specials Clinical Manufacturing is playing a key role in the development and validation of a Glide Pharma product that promises to revolutionise injectable drug delivery. Specials" technical director Brian Dougherty offers an update on the product's progress so far
Northumberland-based Specials Clinical Manufacturing has been working on the process development and validation for a drug product using Glide Pharma's needle-free, solid dose injection technology. The Glide SDI technology will eventually be adapted to a wide range of injectable products, encompassing small molecules and biologicals, including vaccines.
Work on the Glide SDI, which is much less invasive than traditional injection methods, has been ongoing since the company was formed in 2001, initially under the name of Caretek Medical.
Specials Clinical Manufacturing has been working with Glide Pharma on several products. Some can be terminally sterilised, while other more labile substances require an aseptic process using bespoke isolator equipment.
One of the major challenges has been assembly of the drug cassettes for stability testing and clinical trials, a complex task that currently has to be completed by hand. This process will, of course, be automated once manufacturing scale-up goes ahead.
As well as addressing the fear of needles that affects more than 10% of the population, the Glide SDI offers a safe, convenient and easy-to-use alternative to traditional injections. With the potential to avoid refrigeration, the technology is also easier and cheaper to transport and store. In addition, as the drug or vaccine is pushed into the skin, and not fired as with other needle-free technologies, the Glide SDI ensures accurate, reproducible dosing.
Oxford-based Glide Pharma has been working on the design and function of this technology for several years, but the final stage of the process required input from a specialist manufacturing company.
Glide Pharma will continue to work with Specials on the manufacture and testing of the cassettes for different drug types and doses. Internal studies have already been carried out on various drug substances, ranging from small molecules, such as Fentanyl, through to proteins like insulin and erythropoietin as well as vaccines. Recently Specials was commissioned to develop a proprietary isolator system to enable aseptic Glide SDI product manufacturing.
The development work has been undertaken within the Specials site in Prudhoe, Northumberland, which was opened in 2004, following a £5m investment. The site includes 10,000ft2 of cleanroom facilities, offering both sterile and non-sterile manufacturing and analytical/microbiology laboratory testing services, including clinical trials packaging.
The development is Glide Pharma's primary focus at the moment and the project has attracted investment from a number of sources, including the Oxford Technology Venture Capital Trusts.
The technology is covered by a number of broad patent applications that have been filed in all major territories worldwide and the first three of which have been granted in the UK. There has already been intense interest from a number of big-name pharmaceutical companies for a technology that has the potential to reach hundreds of millions of patients.
how it works
The central component of the needle-free system is the reusable Glide SDI actuator, a spring-powered device the size of a fountain pen that is very simple to manufacture, the firm says. Patients simply insert the disposable drug cassette into the actuator. The drug cassette is pre-filled ready to use with the drug or vaccine, which takes the form of a tiny pointed rod.
To deliver the drug, the end of the drug cassette is simply placed against the skin and the actuator is pushed gently towards the skin. This process primes the internal driving spring and, when fully primed, the Glide SDI automatically actuates and pushes the drug through the skin. The pointed end on the drug cassette means that a needle is not required.
The actual delivery of the drug through the skin appears to users to be virtually instantaneous. The simplicity and convenience of the process has been found, in trials, to be one of the reasons why trial volunteers preferred the Glide technology to an injection with a standard needle and syringe.
Following the injection, the drug cassette is thrown away. As it has no needles associated with it, the cassette can be disposed of in standard household waste while the actuator is retained for future use over and over again.
For some applications, such as for the administration of emergency medicines, the Glide technology can be configured as a single-use applicator, ready for immediate and rapid use. In this case, the whole system would be disposable.