CAN RISK BE ENGINEERED OUT OF HPAPI PHARMA PRODUCTION?
Medical research has achieved some extraordinary breakthroughs over the past few years and collaboration between clinicians, researchers and the pharmaceutical sector means that effective treatments are improving outcomes for patients faster than ever. The use of HPAPI (high potency active pharmaceutical ingredients), often highly toxic compounds that target unhealthy cells without damaging healthy cells, has become an area of huge potential for innovation.
But with innovation in new drugs comes the need for increasingly complex and specialist environments to ensure ingredients can be handled safely and preparations can be manufactured with exacting accuracy and quality.
According to a 2018 forecast by Market Research Engine, the global HPAPI (high potency active pharmaceutical ingredients) market is set to be worth $24 billion by 2022 with a compound annual growth rate of 8%. Meeting escalating demand for these highly effective medicines will require the design and construction of highly-specified, specialist facilities.
At BES, we understand the complexities of designing facilities like these because we already have a 17-year track record in delivering pharmaceutical environments that meet the strictest validation requirements and incorporate complex building services to manage airflows and underpin process requirements, operational efficiency and safety.
We’re working with pharma clients to advise on the design, building services engineering and feasibility of such specialist environments and the knowledge within our team is proving invaluable, not least because standards and guidance for HPAPI facilities are so thin on the ground, with best practice based on the experience of those already experienced in the field.
Our approach is to consider the bespoke requirements of the project in the context of the five levels of cascade protection required: process isolation; containment equipment; facility design; PPE and training and health monitoring of personnel. We also use our expertise in pressure regimes, clean air intake and air extract, filtration, temperature and humidity control and facility layout and circulation routes to ensure the mission critical goals of product quality and operator safety can be met.
Using toxic compounds in pharmaceutical production brings with it integral hazards but, at BES, we believe those hazards can be managed without risk if the right expertise is applied to the project from the very first stages of concept development.