While CMO market capacity is adequate for mainstream products, there is a lack of manufacturing capacity for the rapidly growing sub-segment of complex drug products. Such a facility requires not only purpose-built infrastructure, but also a highly specialized staff. To fill this gap, we have established commercial production for complex drug products, leveraging our decades of knowhow as a leading product developer and clinical stage manufacturer. The facility is separate but adjacent to the existing development and clinical trial manufacturing site, offering customers a seamless flow from development through manufacturing – a one stop shop. Our customer-focused staff thrives in a dynamic, highly technical environment. Our team and our facility are ideally sized for complex drug product manufacturing, so you can rest assured that your drug product will get the care and focus it needs to succeed.
Our commercial facility possesses a wide range of capabilities built around complex drug product development and manufacturing, including:
We have built a strong Quality team comprised of Quality Control (QC) and Quality Assurance (QA) that works closely with our development and manufacturing staff to ensure your product is manufactured successfully and to the highest quality standards. Our dedication to complex drug products means that our QC team possess core strengths in analytical method development, physical characterization, forced degradation, commercial validation, and long-term stability testing. Particle Sciences’ staff has extensive experience with a variety of APIs (small and large molecules) and can develop methods to evaluate properties such as assay and related substances, in vitro release, and encapsulation efficiency.
Stability testing and a well-designed ICH-compliant stability program are critical elements of a rigorous drug formulation and development plan, and our facility is equipped with state-of-the-art temperature and humidity controlled/monitored chambers for accelerated and long-term stability testing, including standard ICH conditions, controlled low humidity for semi-permeable containers, and photostability. Finally, our floating quality assurance (QA) group establishes continuity across our organization. Our QA team is integrated into everything we do, and they possess the experience and mindset to deal with the unique challenges of complex drug product manufacturing.