56 TABLETING
CONTINUOUS MANUFACTURINGachieved
Industry interview that explores how an innovative drug manufacturer is achieving continuous manufacturing in pharmaceutical production
P
atricia Hurter, Ph.D. is senior vice president, Pharmaceutical and Preclinical Sciences at Vertex.
Q. T e company was founded in 1989 on a desire to do things diff erently: does the company still strive for innovation and if so, where can that be seen in the company practice and structure?
A. Innovation is in everything we do at Vertex from drug development to the continuous manufacturing process for our medicines. An example is our cystic fi brosis research and development programme, a model for both precision medicine and manufacturing, with innovation in the areas of genomics/genetics, cell biology, chemistry and continuous manufacturing/ real-time release.
Continuous manufacturing is
an innovative process that enables manufacturers to better monitor quality throughout the production process. It enables manufacturing and process development timelines to run in parallel with rapid clinical development. And it provides signifi cant fl exibility throughout the entire manufacturing process. Continuous manufacturing requires a small equipment footprint and can therefore be located in close proximity to the company’s R&D facilities, which can stimulate further innovation and foster collaboration between manufacturing and R&D eff orts.
Q. Has the overall mission changed much; is the company still driving towards developing drugs that can improve the lives of people with serious illnesses?
A. Vertex continues to be committed to discovering, developing and commercialising innovative medicines for a number of serious diseases. Our work in cystic fi brosis brought to patients three medicines so far to treat the underlying cause of the disease – the fi rst medicines to ever address the cause of the disease and not only the symptoms.
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Continuous manufacturing is well suited to manufacturing personalised medicines and those with breakthrough therapy designation, where development timelines may be short and there are many patients in need of transformative new medicines.
Q. How much diff erence does it make to the business to be able to develop a drug in the lab and then move to production swiftly?
A. T e speed of CM allows for the manufacturing of medicines on an “as needed” basis where medicines can be manufactured from active pharmaceutical ingredient (API) to commercial-ready tablets, including all quality testing required to release the product, in a few days as opposed to four-to-eight weeks with a traditional batch process. Under the traditional paradigm, manufacturing may not be able to keep pace with the short development timelines for precision medicines and breakthrough therapies.
Q. Are we on the crest of a wave when it comes to achieving continuous production and real-time release of drugs, and if so, what are the potential benefi ts for the end user?
A. From speaking to colleagues in the industry, it is clear that the interest in CM is picking up momentum, with several companies making substantial eff orts in this area. Once a few companies have demonstrated that the perceived regulatory and technological hurdles of implementing this technology are not standing in the way of success by receiving approval for commercial
products, we think this will reduce the risk substantially for others, and then the benefi ts of CM will be such that anyone not adopting this technology may be at a suffi cient disadvantage. It’s the wave of the future in pharmaceutical manufacturing, in our opinion. It provides the opportunity to monitor quality throughout the manufacturing process, enables manufacturing and process development timelines to run in parallel with rapid clinical development, and provides signifi cant fl exibility in the manufacturing process, ultimately benefi ting patients.
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