TriPharm Services Developing Pharmaceutical Manufacturing Facility In Morrisville
TriPharm Services, a new Morrisville-based contract development and manufacturing organization (CDMO), is commissioning a new pharmaceutical manufacturing operation using the latest isolator manufacturing equipment.
Isolators provide a microbiologically controlled environment for aseptic operations that prevent contamination.
The company says its new facility is meant to address a shortage of parenteral manufacturing options in the United States. Parenterals are sterile preparations containing one or more active ingredients intended for administration by injection or infusion. They are produced in liquid and lyophilized form. Lyophilization is freeze drying, which removes the moisture from the products, making them chemically more stable and prolonging their shelf life. Many drugs are unstable in their liquid form.
CFO Eric Evans said in an interview with the North Carolina Biotechnology Center that isolators are completely sterile environments that operators access only from the outside via a rubber glove port. He said a lot of biologics are very unstable at room temperature. Freeze drying them is a complex technology that gets the liquid out and seals the syringes or vials. A clinician then adds sterile water to them prior to using them for injection or infusion.
The technology for making parenterals is complex and building a manufacturing site is expensive and takes up to three years to construct, Evans explains, which accounts for the shortage of such sites in the U.S.
Facility features state-of-the-art equipment
The new facility, which TriPharm calls a center of excellence, will specialize in injectable pharmaceutical capabilities including flexible manufacturing processes for liquid and lyophilized products. The 32,000-square-foot facility, located at 627 Davis Drive in Morrisville, will offer four isolator filling suites and the highest level of control available for Grade A processing of client biologic and small-molecule products.
Featuring state-of-the-art equipment, the facility has eight multi-purpose cleanrooms to support manufacturing operations, along with modern, specialized utility systems to scale to client requirements.
Co-founders Patrick Walsh, CEO, and Evans have a long track record of creating high-growth organizations in the pharma industry. Walsh was previously CEO of Durham-based Avista Pharma Solutions and drove the rapid growth of the business, resulting in a pre-emptive sale of the company to Cambrex Corp in January 2019 for $252 million. Before Avista, he was CEO of Wilmington-based AAIPharma Services and led the successful growth strategy, culminating in the sale of the company for 4.6 times return on invested capital.
Before joining TriPharm, Evans was CFO of Avista, where he played a key role in the expansion and sale of the company. Before Avista, he was CFO of Mayne Pharma US, a publicly traded company operating in the generic, brand and CDMO pharmaceutical industries, and, at private-equity-backed AAIpharma.
TriPharm, founded in April, is backed by Ampersand Capital Partners, a Boston and Amsterdam-based middle-market private equity firm dedicated to growth-oriented investments in the healthcare sector.
“TriPharm brings a new option to clients seeking modern, well-equipped manufacturing with an experienced leadership team,” said Walsh in the announcement. “We are committed to providing a unique, high-quality service to our clients, given the global need for reliable, flexible and scalable manufacturing of injectable pharmaceuticals.”
The state-of-the-art equipment and facility are set to be fully operable in the second quarter of 2020. Evans said the company currently has about a dozen employees, but expects to hire up to 50 starting around March 2020, and probably more as the facility comes on line.