Microsize has launched its business as an independent company to support solubility and bioavailability enhancement via particle reduction technologies including micronization. This announcement marks the completion of the previously announced intent to acquire the North American micronization business from Lonza in Quakertown PA.

Microsize is the largest micronization business of its kind in North America. It comprises three facilities with over 100,000 square feet of space including an R&D center, analytical development, GMP manufacturing suites, and GMP warehousing. Microsize has a fully integrated business with capabilities from preclinical through multi-ton commercial processing of active pharmaceutical ingredients and excipients in FDA-inspected facilities. Capabilities include handing highly potent compounds (HPAPIs) in both hard wall, and flexible, single-use disposable containment systems. With new therapeutics becoming more complex and potent, Microsize is well positioned to handle these compounds safely and efficiently.

The business was acquired by an investor group of industry veterans with deep expertise in both drug substance and drug product development and manufacture. The chairman of Microsize is Derek Hennecke, who is an experienced executive with a track record of success for over 30 years in the CDMO space, most recently as CEO of Xcelience. TJ Higley is leading Microsize as its CEO, and was a previous owner of the business (Powdersize) before Xcelience, then later Lonza, purchased it in 2017.

“Micronization is a critically important step in the solubilization process, and Microsize is a true leader in the North American market,” said Hennecke. “We’ve gathered a familiar group of seasoned pharma services executives with a proven track record of success in our investor group who take a hands-on approach, and we will benefit from their long-term commitment to making Microsize the global leader in micronization technologies.”

Higley added, “The goal of Microsize is to provide our first-choice bioavailability enhancement technology in the most streamlined way to shorten the development and scale-up pathways with an integrated approach from early development through commercial launch quantities. I look forward to leading the Microsize team to ensure we provide the best customer experience in the industry.”

Microsize enjoys world-class facilities and infrastructure which have seen significant investment over the past five years in containment technologies, quality management systems, and analytical capabilities. The company says it is positioned to provide the high customer-touch, flexibility, speed and nimbleness of a smaller organization, combined with the world-class facilities, quality systems and capabilities customers come to expect from a larger global CDMO.