This morning Clinuvel announced a significant milestone in its development program for SCENESSE®: the signing of the first manufacturing agreement for the final drug product with SurModics, Inc., a leading provider of drug delivery technologies to the healthcare industry. It has taken over eight years for Clinuvel to reach this milestone. In this time, the company has refined SCENESSE’s active ingredient – afamelanotide – and arrived at a final injectable drug product which controls its release to achieve an optimal photoprotective response in patients.
Manufacturing is a core component of the research, development and commercialisation of pharmaceutical products. Determining where and how to manufacture a product is an important step in a commercialisation program and in the overall life cycle of a drug product: should a company stand alone and develop in-house capabilities, or partner with an external organization to develop and manufacture its product, and where should manufacturing take place? The answers are not an easy, but must be arrived at early on in the product’s life to address the complex, bespoke nature of manufacturing; particularly when dealing with new active ingredients and formulations or unstudied diseases.
Every step of the development process requires continuous, in-depth involvement of a manufacturing team, or partner, to ensure that the correct product is developed precisely: according to the research on hand and such that products can be replicated on the scale necessary to ensure continuous supply for research needs or commercial ventures.
Determining the required dose, the method and rate of administration and achieving a product’s desired pharmacodynamic and pharmacokinetic profile is an exact, time consuming procedure. It’s not something which could, or should, be done overnight. A product must then be manufactured according to stringent internal and external requirements to ensure it satisfies the quality necessary to be administered to humans.
Knowledge, imagination and analysis are required to reach a product which meets these demands, as well as satisfying the needs of both physicians and patients. Ongoing attention to detail and stakeholders is vital.
Yet, last month the Wall St Journal quoted Prabir Basu, executive director of the National Institute for Pharmaceutical Technology and Education (NIPTE), saying that manufacturing was the ‘stepchild’ of the pharmaceutical industry.
While they may be unkind to stepchildren worldwide, Basu’s comments – part of a broader story which focused on manufacturing troubles and their flow on effects experienced by large pharmaceutical and biotech companies – essentially suggested that manufacturing had become a headache for pharmaceutical executives who don’t understand the upkeep necessary to continue to meet ever evolving manufacturing technologies and good manufacturing practice (GMP) requirements. The WSJ implied the pharmaceutical industry’s response was to increase in-house manufacturing expertise to address manufacturing issues, but WSJ suggested that such responses were still works in progress.
Clearly a different ongoing approach is needed to ensure manufacturing runs smoothly in an industry where so many other, almost uncontrollable, risks must be mitigated to ensure success.
In this context, it is testament to Clinuvel’s necessary innovation to have reached a pivotal point in the development of SCENESSE®: being able to confidently manufacture the lead drug on a commercial scale. By considering manufacturing at every step of development, then continuing to involve manufacturing as part of the lifespan of the product, the company now has a clear commercial and competitive advantage as we progress our global clinical program. For the team, it is eight years well spent. For patients, light is ahead.
Image refernce:
http://www.flickr.com/photos/sailorbill/190701427/
