Aptar CSP Technologies launches cGMP early-stage clinical manufacturing site

Aptar CSP Technologies, part of AptarGroup, has announced the expansion of its service offerings with the launch of a cGMP-compliant manufacturing facility in New Jersey.

The new site will support clinical packaging for oral solid dose (OSD) and capsule-based DPI drugs utilising Aptar CSP’s proprietary Activ-Polymer platform and Activ-Blister solutions. 

The expansion addresses growing market demand for enhanced drug stability and nitrosamine risk mitigation. Aptar CSP’s Activ-Blister technology integrates a highly-engineered active film material into thermoform and cold-form blister packaging configurations, creating a microclimate that protects individual doses from moisture, oxygen, VOCs, and degradation, including reducing the risk of N-nitrosamine formation. The technology delivers customizable, dose-specific protection tailored to the unique stability needs of each drug formulation. 

“Launching this cGMP facility reinforces our commitment to delivering streamlined access to innovative active material science technologies for patients and pharmaceutical partners,” said Badre Hammond, vice president commercial operations and general manager, Aptar CSP Technologies. “By offering early-stage clinical services with custom-designed equipment, we simplify adoption, eliminate implementation barriers, and help avoid lengthy reformulation or repackaging efforts.” 

The new site, which is the result of a collaboration with MOD3 Pharma, will offer services including R&D support, Phase I and II clinical material manufacturing, full CMC package (Chemistry, Manufacturing, and Controls), stability studies, and clinical supply management. 

Aptar CSP’s 3-Phase Activ-Polymer platform technology is trusted worldwide to protect high-value products such as drugs, diagnostics, probiotics, medical devices, and implants.  

(Source: ISPE)