- The Ritedose Corporation has opened a new current Good Manufacturing Practice (cGMP) analytical chemistry laboratory as part of an investment of more than $17 million.
- The new laboratory and expanded microbiology facilities triple the company’s laboratory footprint and expand its analytical testing, stability study, and pharmaceutical manufacturing support capabilities.
The Ritedose Corporation has opened a new current Good Manufacturing Practice (cGMP) analytical chemistry laboratory at its Performance Park manufacturing campus. The more than $17 million investment, combined with an expansion of the company’s microbiology laboratory, triples its laboratory footprint and adds in-house analytical services to support pharmaceutical partners from early-stage development through commercial manufacturing.
The new facility expands Ritedose’s capabilities in analytical testing, method development and validation, product characterization, raw material qualification, finished product release testing, and regulatory compliance. Its laboratories use chromatographic, spectroscopic, and mass spectrometric technologies to test raw materials, active pharmaceutical ingredients, excipients, packaging components, in-process materials, and finished drug products. Additional services include extractables and leachables testing, nitrosamine detection, elemental analysis, and drug product de-formulation to support chemistry, manufacturing, and controls (CMC) programs, bioequivalence studies, and regulatory submissions.
A key component of the expansion is a stability program supported by 10 qualified International Council for Harmonisation (ICH) stability chambers. The chambers support long-term, accelerated, intermediate, refrigerated, and controlled room temperature studies, as well as freeze-thaw and photostability testing. These services provide data to support product quality, performance, shelf life, regulatory submissions, and commercial product lifecycle management.
“This investment represents much more than additional lab space—it’s investing in the future of pharmaceutical innovation. The facility strengthens the company’s analytical capabilities and scientific expertise as pharmaceutical therapies become more complex. Chastain also said the new laboratory, together with the expanded microbiology capabilities, is intended to provide support from development through commercial manufacturing and long-term stability testing.”
Ritedose President and CEO Jody Chastain
The laboratory opening follows other investments by Ritedose, including an expansion of sterile Blow-Fill-Seal (BFS) manufacturing capacity, the addition of a seventh Syntegon packaging line, and the opening of a logistics and distribution center at Performance Park. The company said these investments strengthen its ability to support pharmaceutical partners from clinical development through commercial supply while increasing capacity for sterile ophthalmic and respiratory therapies.
