Keith Koehler, President & CEO, Excite Pharma Services
Keith Koehler, President & CEOThe pharmaceutical industry has become more proactive about product quality and patient safety at every stage of the development and manufacturing processes. Many companies in the industry have realized that a “one-size-fits-all” approach can no longer deem adequate for the specific requirements of certain patient population subsets. This personalized approach can not only help the industry evolve into the next stage but also shift a needed focus onto niche markets even during the research and development phase.

“Having spent 30 years in the pharmaceutical industry, I realized the future is going towards personalized medicine and specific drug compositions in smaller batches that offer increased patient safety,” says Koehler, President & CEO of Excite Pharma Services. He witnessed firsthand how compromising on drug concentration could prove fatal. His wife’s uncle, who suffered from a cancer condition that had a 90 percent recovery rate, passed away due to drug dilution. The incident helped inspire him to address the largely overlooked issues pertaining to patient safety and drug quality through small-batch aseptic drug manufacturing and compounding.

Excite Pharma Services is rooted in this patient-centric philosophy.

Founded in 2009, Excite Pharma Services is a premier small-scale aseptic drug manufacturer providing analytical chemistry CMC services for APIs and drug products. Excite has the capabilities to meet both human and animal drug needs. Their cGMP sterile fill and manufacturing facility consists of four cleanrooms (ISO 5-8 certified) that handle Phase I and II hand fill operations and small-scale commercial needs for injectable products. The company’s multiple aseptic hoods provide the ideal sterile environment for clinical trials and research.

Excite has a wide range of multiple dosage forms, including injectables, vials, spray products, and eye drops.

Excite Pharma Services: Employing Patient Safety in Small Batch Manufacturing

The company provides both small (20ml or less) and large-volume (1000 to 500ml) filling capabilities for bottles or vials and a filling line for spray products. Excite also has semi-automatic syringe filing capabilities for clients requiring only a few thousand units.

Besides the manufacturing capacities, a significant part of Excite’s business pertains to analytical chemistry. As a one-stop-shop, the company offers method development, validation, stability testing, release testing, as well as lab equipment for specialty tests like High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), Inductively Coupled Plasma Mass Spectrometry (ICP-MS), and Gas Chromatography- Mass Spectrometry (GC-MS) analysis. They also hold a 503B license for compounding and Drug Enforcement Administration (DEA) certificate for manufacturing that involves scheduled substances.

Having spent 30 years in the pharmaceutical industry, I realized the future is going toward personalized medicine and specific drug compositions in smaller batches that offer increased patient safety

The business model that discerns Excite from its competitors is centered on catering to unique client needs. Clients often approach Excite with a distinctive or new dosage form that is difficult to find elsewhere. In cases like these, the company offers a collaborative partnership where they provide essential facilities and people while the clients provide the necessary equipment. For instance, one of their clients wanted a small-batch manufacturing facility that complied with 503B compounding requirements. The client had checked out other production facilities but was not satisfied. They approached Excite and observed their production facilities and processes. Impressed by Excite’s manufacturing prowess and efficient workflow, they partnered with Excite to streamline their drug compounding needs.

As an FDA-registered, GMP/GLP compliant company, Excite mandates transparency in all its practices. The company’s culture that facilitates honest and direct interaction with clients at every stage of the onboarding process is a testament to this. For the road ahead, Excite is coming up with a new nasal gel line and is also planning to expand on its analytical and biomolecule chemistry offerings. “We will eventually move into a larger scale manufacturing to entertain other dosage forms,” says Stephanie Greenwood, Business Development Specialist.