Dec 8 2009
Particle Sciences Inc. (PSI), a leading pharmaceutical CRO, has further expanded their High Potency Compound (HPC) handling capabilities through a unique relationship with IES Engineers. "HPCs are an increasing part of our business and an area that many CROs are unwilling to make the necessary investment in to safely handle them," says Dr. Robert Lee, PSI's VP Pharmaceutical Development. "Each HPC is different and requires its own set of considerations. Companies need both the physical and staffing infrastructure to work with them. For PSI, the key task was proper strategic staffing maximizing not only our ability to work with HPCs but to do it in a way that was commercially viable," Dr. Lee went on to say.
Under the arrangement, IES Engineers will be responsible for evaluating incoming materials and placing them into exposure control bands, which specify the safe procedures around their handling and processing. IES will also be involved in specific design and implementation of HPC related procedures. In this way, PSI gains the experience and vast capabilities of one of the world's leaders in potent compound safety. According to George Petroka, Director BioPharma/EHS Services at IES Engineers, "This is the standard approach adopted by big Pharma for working with HPCs, but is not as common outside of that group, and demonstrates PSI's dedication to working with HPCs and providing innovative HPC services. By using IES Engineers in this capacity, PSI is assuring their clients of industry-leading practices and careful review of procedures. It would be very difficult for a midsized company to acquire the level of expertise we can provide."
Dr. Lee further stated, "Our core areas are nano-based systems and difficult to formulate APIs both in semisolids and combination products. Obviously, a great number of these products are HPCs such as oncology agents and various hormone preparations. Expanding this capability only makes sense as we look for better ways to serve our client base."
IES is a fully integrated engineering and environmental, health, and safety consulting firm providing an extensive range of technical services to the bio/pharmaceutical, healthcare, specialty chemical, food, printing, and industrial sectors. Client speed to market, aggressive schedule deadlines, quality, regulatory compliance, and best management practices drive our project performance. As the consultant of choice, our primary focus is to improve our clients' financial performance and reduce liabilities while helping them maximize their competitive advantage.