Regulatory requirements for cell and gene therapies
These products, known as "Advanced Therapy Medicinal Products" (ATMPs), are a revolutionary innovation in medical treatment.
Their current rapid development and increasing acceptance are bringing individualized therapies for cancer, metabolic, viral, and autoimmune diseases within reach. The newly developed therapeutics are diverse and include biomolecules produced by gene transfer, biologically modified cells, and bioengineered tissue products.
ATMPs are defined by Regulation (EC) No 1394/2007 in conjunction with Directive 2001/83/EC. Their manufacture is regulated by various national laws and regulations, as well as by the SoHO Regulation (EU) 2024/1358 (for starting materials) and the EU GMP Guidelines (specifically Part IV).
In addition to the general GMP requirements for the manufacture of pharmaceuticals, there are many product-specific regulations for cell and gene therapies that require special GMP solutions. Valicare offers a broad portfolio of services for the manufacture of both pharmaceuticals and ATMPs.
We have been working successfully in the classic GMP sector for more than 20 years and since 2016 also in the cell and gene therapy environment. Our experts are familiar with current regulatory requirements that apply to these special pharmaceuticals and can offer you consulting support at the highest professional level.
Would you like to shape the future with cell and gene therapeutics? We will be happy to support you on your way to GMP-compliant manufacturing. Find out more about our our special ATMP services and the latest news about cell and gene therapies. Together we will take your therapy to the patients.
