Xcelience and IriSys partner to offer US regional access to CMC and regulatory expertise

By Alexandria Pesic

- Last updated on GMT

Related tags Pharmacology

Xcelience and IriSys have formed a joint venture to help streamline access to chemistry manufacturing and controls (CMC) and regulatory expertise for North American pharmaceutical and biotechnology companies.

Under the deal, IriSys will contribute its experience of moving compounds from early research to Phase I and II clinical trials, as well as its regulatory filing services. Formulation development company, Xcelience, on the other hand, will offer the scientific expertise to aid acceleration of the early drug development process.

The downturn has seen drug firms refocus on development competencies and farm out “non-core” activities, such as CMC and regulatory submission to third-parties to cut costs. This has prompted a number of CROs expand their regulatory offerings, with Xcelience and IriSys being just the latest agreement.

Impressed by Xcelience’s “solid dosage form technology expertise in filling an active pharmaceutical ingredient [API] into capsules” ​and “project management system,”​ Gina Stack, president and CEO of IriSys said: “Our common philosophy, organisational culture, and inherent commitment to quality make the alliance a natural fit.”

Derek Hennecke, president and CEO of Xcelience said: “This alliance provides a unique opportunity to leverage these strengths in conjunction with our own in a way that minimises client risk, and maximises client accessibility to the strategic locations of each company on the east and west coasts of the US.”

Coast to coast CMC

The two US based companies also cited expanding their geographical reach as a factor in the accord, given that they are located on different sides of the American coast, with Xcelience’s headquarters in Tampa, Florida, and IriSys based in San Diego, California.

IriSys was founded in 1996 as a contract services organisation focused on formulation development for compounds at all stages of development as well as GMP manufacturing of clinical trial materials.

Since 1997, Xcelience has been providing formulation development, preformulation, analytical and clinical trial manufacturing services.

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