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This dedicated facility is a direct result of the company's continued commitment to purpose-built facilities and the support of several customers.
The expansion provides a dedicated, cGMP clinical and pilot-scale facility for the development of programs in clinical trials. Importantly, this allows customers to validate their product, manufacturing process, and assembly activities as part of the clinical trial regimen, improving speed to market and reducing risk.
The clinical and pilot-scale facility allows for critical scale-up activities prior to programs ramping to new product introduction (NPI) and commercialization at one of Phillips-Medisize's 14 manufacturing facilities around the globe. Demand for this capability is driven primarily by the company's rapidly growing drug delivery segment, and it is expected to support consumable diagnostics and medical device customers as well.
"The investment in this facility showcases Phillips-Medisize's continued commitment to purpose-built facilities, which in this case supports our customers' clinical development efforts. We will continue to invest in our people, processes, and facilities necessary to support our biopharmaceutical, diagnostic and medical device customers throughout their product development cycles," commented Bill Welch, Phillips-Medisize Chief Technology Officer.
Improvements to the facility include expansion of the Class 7 cleanroom space and critical systems. Additionally, LED lighting was installed to reduce power consumption. Future capabilities under consideration for the facility include drug handling and drug delivery device packaging, pending completion of appropriate registrations. All Phillips-Medisize locations supporting healthcare customers are ISO 13485 certified, including Design Controls in US and Europe Design Development Center locations.
