PCT is the global contract development and manufacturing services platform of the Hitachi Chemical Regenerative Medicine Business Sector, represented in the United States by Hitachi Chemical Advanced Therapeutics Solutions, LLC, a leading external development and manufacturing partner that focuses exclusively on the cell therapy industry.
We offer industry-leading cell therapy development and manufacturing expertise to:
Accelerate your progress to market
Anticipate and overcome challenges on the way to commercialization
Reduce the overall costs and risks of your clinical development program
PCT’s resources and capabilities help clients overcome the unique challenges presented by cell therapy manufacturing as product candidates approach commercialization, and help better position the therapeutic for long-term viability.
Proven track record of success: Only CMO to see client’s cell therapy product receive approval from the FDA for commercial sale.
More than 200 employees—including more than 10 PhDs—offer deep and diverse therapeutic platform experience in the areas of immunotherapy, cell-based gene therapy, hematopoietic replacement and tissue repair/regeneration. As part of our Manufacturing Sciences and Technology group, our bioengineers study existing tools and develop new approaches to increase the reliability of cell therapy manufacturing processes reduce the cost of goods and deliver the necessary quality standards for your clinical applications.
PCT has cGMP-compliant,
Our client-focused approach is designed to deliver world-class service. We earn the trust of our clients because for us it’s about developing the long-term relationships built upon satisfaction with the PCT experience. Our goal is to be viewed as your partner, an extension of your in-house team, by delivering the expertise, strategy, teamwork, efficiency and accessibility you demand.
At PCT, your milestones are our milestones. Timely achievement of clinical milestones is essential to the success of a development-stage cell therapy company. We know this is the lifeblood of our clients. After your project plan is established, PCT will partner with you to do what is needed to keep your program on track and to ensure that you meet applicable quality standards, through regulatory approval and beyond.
We are a partner in your progress to commercial-phase manufacturing, making continuous investments in best-in-class technologies, quality systems and human resources.