Kymanox opens Formulation Lab to address early drug development challenges
Kymanox has opened a new Formulation Lab to provide formulation development and analytical testing services for pharmaceutical and biotechnology companies moving programs from early research into clinical manufacturing.
Located near the company’s headquarters in Morrisville, N.C., the new facility provides specialized formulation development services, and analytical characterization and process optimization capabilities for small molecules, biologics, and advanced therapy medicinal products (ATMPs).
“North Carolina already has world-class strength in large-scale manufacturing and clinical research,” said Ryan Doxey, who is the Vice President of Technical Services at Kymanox and oversees the lab. “What's been missing is strong support for the early stage between when a promising drug is still being formulated and tested and before it's ready to scale. Kymanox's Formulation Lab fills that gap, so companies can take a product from early concept all the way to commercial scale within North Carolina.”
Supporting early development
Doxey points out that many of Kymanox’s clients are small, lean biotech companies with strong science but limited staff and funding. This means they need fast, reliable formulation that works the first time. At the same time, investors and boards are increasingly pushing for stronger data earlier so they can derisk a product before committing to larger trials.
“This puts more scrutiny on things like stability and product characterization, earlier in the process than before,” Doxey said. “Our Formulation Lab is built for that: We develop formulations and characterize them properly, using the right analytical methods, so they transfer smoothly to clinical manufacturing.”
The new facility complements Kymanox’s existing consulting services in regulatory affairs, quality assurance, manufacturing support, and validation services.
Current capabilities
The Formulation Lab is staffed by a multidisciplinary team with experience in CMC (chemistry, manufacturing and controls), pharmaceutical sciences and process engineering across small molecules, biologics and advanced therapies.
It supports multiple drug delivery modalities including pulmonary, oral, injectable, transdermal, nasal, implantable, and ophthalmic applications and is equipped to develop and characterize aqueous formulations, non-aqueous formulations, suspensions, liposomes, and in situ gels.
The facility also has the equipment necessary for temperature-controlled stability studies across the full storage range. Analytical capabilities are available in-lab or through pre-existing partnerships for advanced analytical needs.
“We can now support the entire product development continuum, from formulation optimization through device verification and human factors validation, under one integrated service model,” said Nicholas Ciccarelli, Chief Operating Officer at Kymanox. “This seamless approach reduces handoff risks and accelerates time to market.”
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