cGMP Manufacturing, Infrastructure and Systems

Reliable and Trusted CGMP Manufacturing Infrastructure and Systems

As a part of Hitachi Chemical Advanced Therapeutics Solutions (HCATS), the PCT global service platform has a robust current good manufacturing practice (CGMP-Quality system)-compliant infrastructure that is trusted by many cell therapy development organizations. For over 20 years, cell therapy developers have relied on our contract manufacturing capabilities to meet their production and development needs for more than 25 different types of cells and tissues.
We listen to our clients’ needs, learn their specific challenges, and adapt our own processes to create a robust and reliable contract manufacturing partnership.  Also, we do not claim ownership of your cell therapy manufacturing process—even when we help to develop and refine it.
It’s your product and your data to do with as you will.

Our CGMP manufacturing capabilities include:

Extensive Experience with CGMP Manufacturing for Phase III Trials

We have over two decades of experience in contract manufacturing and the development of cell therapy products that have helped cell therapy developers identify and resolve the issues that arise during clinical trials.

In particular, we help organizations pave the way towards reaching commercial manufacturing readiness—identifying issues that impact the quality, scalability, sustainability, and cost of goods for their cell therapy product and providing advice for overcoming them.

Automation and Closed Systems

We can automate many cell therapy manufacturing processes, including the finishing and filling of a therapy product. This allows us to create closed systems that enhance the efficiency and reliability of cell production and improve CGMP compliance for the product.

By automating the fill/finish process, we can minimize the risk of last-minute product contamination and failure in the cleanroom. By creating closed systems, we can run multiple therapeutic cell manufacturing processes concurrently—increasing our productivity so we can complete more batches of therapeutic cells in less time. Our automation also allows us to integrate many manufacturing steps into a single process to further maximize consistency and speed of production.

Cryopreservation of Cell Therapy Products

Our controlled-rate freezers enable us to apply cryopreservation to cell therapy products, increasing the potential distribution area of your CTPs by prolonging their shelf life—something that is a common limiting factor for many cell therapy products.

Combined with our extensive distribution network, which includes special partnerships with air carrier fleets we can significantly extend the reach of your cell therapy product.

ISO 7 and ISO 6/Grade B Cleanrooms

In the U.S., we have two CGMP manufacturing sites (New Jersey and California) with ISO 7 and ISO 6-grade cleanrooms where cell therapy products (CTPs) can be produced. A third facility (in New Jersey) designed to serve the needs of commercial stage cell and gene therapy development and manufacturing has recently launched. Our global network includes a manufacturing facility in  Yokohama, Japan and Munich, Germany through apceth Biopharma. This gives our team the ability to perform CGMP-compliant cell therapy manufacturing in different regions.

CGMP-Compliant Manufacturing Infrastructure

Our infrastructure for providing CGMP-compliant contract manufacturing services means having the right facilities in the right place for your distribution needs. Our manufacturing infrastructure is the product of nearly two decades of experience in contract manufacturing and development. Using this experience, we have built a robust manufacturing and logistics infrastructure reinforced with highly-refined practices and processes.
This infrastructure is one part of how we deliver on our promise to our clients: To build a lasting and fruitful manufacturing partnership that helps you exceed CGMP compliance standards while optimizing your product’s commercial viability.

Some of the systems and services that all of our clients can benefit from include:

  • Materials, equipment, and facilities controls that protect the integrity of your cell therapy production process.
  • Deviation, Corrective and Preventive Action (CAPA) processes that eliminate the causes of non-conforming production.
  • Change and document controls that ensure you’re always aware of your cell therapy product’s condition.
  • Quality control and assurance systems that apply a development by design (DbD) strategy to ensure quality, scalability, sustainability, and cost of goods are all well-controlled.
  • Closed system manufacturing and automation capabilities that enhance productivity and consistency in cell therapy manufacturing.
  • Manufacturing development services to help cell therapy developers improve their manufacturing processes—including a strategic commercial manufacturing plan (SCMP) and a strategic manufacturing assessment (SMA) to ensure consistent and reliable progress towards commercialization.
  • Training services to help your team meet specific U.S. FDA requirements or learn new manufacturing processes. We will also send our team to train with yours to learn your cell therapy manufacturing processes.

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