July 28, 2021
PHC Corporation of North America
Wood Dale, IL - The pharmaceutical services industry includes contract research, contract manufacturing and contract sales organizations that offer services for hire, and while it has existed since the 70s, the development of the cell and gene therapy services sector represents a new frontier. The complexity of cellular and gene therapy manufacturing goes far beyond basic cell line development used in biologic drugs of the past, relying on genetic engineering, growth and purification, as well as cellular engineering.
As a relatively new industry, this frontier is being pioneered by only a handful of companies that face numerous challenges. In truly innovative and emerging fields, processes are optimized as they go, often through trial and error. Trying to establish these standard processes amid workforce development issues and remain innovative is akin to building a vehicle while attempting to drive it.
One key standard that ensures a universally safe and efficient biologically derived product is a properly maintained cleanroom.i As the industry evolves, so too will the future of international regulations for adequate cell and gene therapy manufacturing processes. While industry leaders determine many processes, signs indicate that a properly maintained cleanroom will be a global requirement. Though cellular and gene therapy manufacturing is more complex than basic cell culturing, it is just as susceptible to contamination. Therefore, reproducibility and reliability of results depend on adherence to current GMP requirements.
ISO cleanroom classified equipment is essential in achieving high quality, repeatable results that meet cleanroom and GMP guidelines. ISO certification provides reassurance that facilities can meet the demands of cleanroom and GMP guidelines without compromising equipment performance.
PHCbi brand products have been carefully designed, engineered and constructed to fit seamlessly into any space or protocol. Enable your cleanroom status with the ISO-classified PHCbi brand cell culture incubators and ultra-low freezer. Visit https://phchd.com/us/biomedical/cleanroom.
iPeter G. Childs, Stuart Reid, Manuel Salmeron-Sanchez, Matthew J. Dalby, "Hurdles to uptake of mesenchymal stem cells and their progenitors in therapeutic products," Biochemical Journal, J. 477, no. 17 (September 2020): 3349-3366, https://doi:10.1042/BCJ20190382.