Particle Sciences – a Lubrizol LifeSciences company – announced plans to open the commercial manufacturing facility before the end of Q4 2018, at CPhI Worldwide last week.
Located next to the contract development and manufacturing organisation’s (CDMO) development and clinical trial manufacturing site in Bethlehem, Pennsylvania, the facility will support the manufacture of both sterile and non-sterile finished drug products, including ophthalmics, injectables, and lyophilized drugs.
According to Particle Sciences’ recently appointed president, Robert Lee, the facility is part of an overall business unit investment of $60m (€51.8m).
in-PharmaTechnologist (IPT) spoke with Robert Lee (RL) to ask what drove the firm’s investment plans, and on a more personal note, what he hopes to achieve as president of Particle Sciences.
IPT: What prompted Particle Science’s decision to expand manufacturing capabilities?
RL: The decision was largely prompted by our customers – we work with some very creative and technologically advanced clients. Some of the complex dosage forms we develop for them would create a challenge in finding a commercial manufacturing option, if it were not for this investment.
From a contract manufacturing services market perspective, we see a big opportunity. The market for services is growing, yet the supply of CMOs interested in taking on these complex drug products is not.
We have purposely built the facility to accommodate smaller batch sizes and complexities, such as the need for aseptic manufacturing. We can certainly handle simple solutions, but we specialise in processes like aseptic nanomilling that no other for hire commercial provider can supply
IPT: Do you expect this expansion to attract new business?
RL: Absolutely, the expansion will undoubtedly attract new business. We have met with clients and other CMOs, which are currently developing nanoparticulate suspension formulations that have no place to turn for commercial manufacturing once Phase II trials are complete.
The first projects will be from US and European clients, but we also have interest from India, where companies seek out our capabilities as they expand into complex generic products.
IPT: Will the expansion create new jobs?
RL: Yes, the expansion is expected to increase employment at Particle Sciences by approximately 30%, with jobs ranging from production and quality control positions to support functions, such as analytical services.
IPT: What do you hope to achieve in your time as president of Particle Sciences?
RL: I hope to increase the company’s organic growth through expansion of our technical capabilities and continuation of our client-centric approach to projects.
The success of our soon-to-be-qualified commercial drug product manufacturing facility, at our headquarters in Bethlehem, is also a key priority over the next few years.
IPT: How will your previous experience benefit this new position?
RL: I have always worked in roles focused on complex drug product development and manufacturing, and have gained an in-depth understanding of this space. Previous roles at NanoSystems, Lyotropic Therapeutics and Novavax, before I joined Particle Sciences, gave me valuable experience in the formulation and development of small and large molecule active pharmaceutical ingredients (APIs) using a variety of techniques to enhance biological performance and/or improve patient compliance.
Much of that experience translated directly to the work of Particle Sciences, particularly my exposure to nanomilling techniques. Nanomilling is one of our key offerings and we are currently the only for hire organisation that can perform good manufacturing practice nanomilling under aseptic conditions.
Over the past decade at Particle Sciences, I have been involved in almost all client projects covering all therapeutic classes of API and all routes of administration, ranging from oral through parenteral through topical/mucosal.
Robert Lee has worked at Particle Sciences for 10 years, in pharmaceutical R&D of therapeutics drugs and diagnostic imaging agents. Before accepting the role of president, he served as executive VP of pharmaceutical services at the firm. Lee holds bachelor of sciences in both chemistry and biology from the University of Washington, and earned a PhD in physical bioorganic chemistry from the University of California, Santa Barbara.