Can you give me an overview of the services Xcelience provides to the pharmaceutical industry?
Xcelience offers a range of services, specifically preformulation, analytical development services, release and stability testing, formulation development, cGMP manufacturing, small-scale commercial manufacturing, and global clinical supplies packaging and logistics. We are always adding capabilities based on client needs. Just this summer, we strategically invested in Powdersize, a Pennsylvania-based company with outstanding technology for milling, micronization and powder classification services with excellent containment controls regardless of potency designations.
What sets Xcelience apart from other companies? What is “Suite Science?”
Suite Science refers to the combination of services we have put together to best serve our clients. We are always thinking about what makes sense when we add to our capabilities. We were the first company of our size to offer clinical supplies, the first to go global with distribution and now we have invested in Powdersize, one of two outsourcing companies capable of micronization in the US.
Our suite of services is precisely what sets us apart. Most companies make decisions about what services to offer from the thirty thousand foot level. Imagine designing a city from a landscape viewed out the window of a jet. You might block off that nice flat terrain for farmland, the area near the river for your downtown, put a dam at the top of the river. These things all look fine from 30,000 feet. But when you come down to 5,000 feet, you see that the soil is too rocky to farm, the land near the river is too unstable to support skyscrapers, and the river is too small to dam.
Many drug companies operate at the 30,000 foot level. I see it all the time. They slap a toxicology lab into a bioanalytical group. These links look fine from 30,000 feet but make no sense to clients. At Xcelience, we look at what our customers experience up and down the pipeline and what we can do to make their experience as easy and cost-effective as possible.
When we saw how frustrated our small to mid-size clients were with the inflexibility and high cost of large-scale packaging services, we built a dedicated facility that could produce and ship small quantities for clinical trial purposes quickly with a significant cost reduction.
Over the past year, we noticed a significant jump in demand for high quality, contained micronization. This is not a piece of the puzzle that is visible from 30,000 feet up, but up close, it’s very much on our clients’ radar. By investing in Powdersize we have been able to align their services with ours to offer clients one smooth process with no disruptions.
Tell me about your facilities, equipment and personnel. How do they work together to provide the best possible services for your clients?
We have six specialized facilities and nearly 200 employees. By assigning each client to a single, highly-skilled project manager, we are able to pull together many threads into a single, custom-woven fabric. We pride ourselves on flexibility. Clinical trials are characterized by unpredictability, and because we manage more than 40 molecules a year, we are well positioned to help our clients expect and adapt to the unexpected. We offer constant communication so clients always know exactly how their molecule is performing and where it is in the process.
We’re also very responsible with API. Recently we had a project that needed micronization and brought it to Powdersize. With only a limited amount of API (~ 100 grams), we made six discrete batches of various particle size outputs with only five percent total API loss.
What are some recent investments/expansions/ acquisitions that have better positioned your company to serve the needs of current and future clients?
Our strategic investment in Powdersize is a very big deal. We were attracted to this micronization company by its near obsessive emphasis on clean systems. They have their own unique technology to reduce and contain dust, which preserves API while protecting employees. They also have made significant investments in an oil free air compressed air supply via an oil free compressor, redundant validated filtration and continuous testing during operations that is very effective in preventing gaseous hydrocarbon from entering the product.
We will continue to focus on the orphan disease market. Our small size is suited to the scale of production for this niche. Small patient populations usually mean that trials for orphan diseases have to expand overseas, and it was for this reason that we added our MHRA-approved UK facility in 2013. No other company our size can distribute in the UK and Europe.
Looking ahead, where do you envision Xcelience to be in five years?
We have a number of capabilities we’re analyzing at the moment, but we also want to be careful to take the time to adjust to each new phase of expansion. In the past three years we added packaging and distribution, moved into the UK, invested in Powdersize and now we’re moving into small-scale commercial manufacturing - we have four FDA pre-approval inspections in the works and another five in the pipeline. Did I mention we are also moving into a new, larger headquarters with a brand new custom-designed lab in October? I’m going to wait at least a couple of months before I bring another new idea to the management team.