The new end to end compliance solution supports operational readiness for cell and gene therapy companies.
FREMONT, CA: Integrated Project Services, LLC, is a leading provider of consulting, architecture, engineering, construction management, and CGMP compliance services. The company is engaged in developing innovative business solutions for the biotechnology and pharmaceutical industries. IPS is uniquely positioned to support the cell and gene therapy industry and has expert professionals in different parts of the world. It is one of the fastest-growing companies in the world.
To simplify the complexities associated with activities in bringing a new cell and gene therapy facility to a fully operational state, IPS announces the launch of CarTon, an end-to-end integrated operational readiness compliance solution for cell and gene therapy facilities. This end-to-end compliance solution includes the entire process life cycle, including facility and process requirements, QMS/SOP development, standardized protocol templates, training, and other requirements for cGMP manufacturing in a global market.
CarTon supplants the robust offering of services, including compliant facility design, traditional and modular construction, engineering, and all features of commissioning, qualification, and validation. Cell and gene therapy companies deploying CarTon can achieve Quality by Design CGMP facility, compliance through commissioning, qualification and validation, and operational readiness - quality management systems documents and services all under one company.
Combined IPS' core services provide cell and gene therapy companies with a complete turn-key solution to get their medical brilliance to awaiting patients. The IPS and G-CON Manufacturing collaboration, offers a modular facility platform, iCON, providing the most flexible prefabricated cleanrooms to address the growing modular and mobile demands of the industry. CarTon takes the iCON solution one-step further to a fully operational, integrated solution or as an independent operational readiness solution on any project.
"With hundreds of cell and gene therapies in clinical trials, we are excited to launch this new, all in one box, end-to-end compliance solution to support operational readiness for cell and gene companies," stated Vince Cebular, SVP, Compliance in a press release. "We created CarTon because time is lives."z