Cell and Gene Therapies (CGT)
Reduce time to market for new therapies for genetic and orphan diseases
Biologic based medicines are as important today as synthetically produced medicines. New therapies like cell and gene therapies (CGT) offer huge potential as treatments for a wide range of diseases including cancer, neurological, and genetic diseases. Therefore, it’s essential for pharmaceutical companies to reduce manual labor and integrate processes and workflows with industry-specific automation hardware and software solutions.
State-of-the-art production methods for ATMPs
Advanced therapy medicinal products (ATMPs) include three different product classes – gene therapeutics (GTP), somatic cell therapy medicinal products (CTP) and biotechnologically tissue engineered preparations (TEP).
ATMPs can be produced allogeneically, meaning they rely on a single cell source to treat many patients or on personalized medicines. (autologous) which are manufactured as a single lot from the patient being treated. During the production of ATMPs, state-of-the-art methods from molecular biology, cell biology, genetics and biotechnology are used. In the future, these novel drugs could be used increasingly, particularly in the treatment of orphan diseases, cancer and hereditary diseases as well as in regenerative medicine.
Benefit from fast ramp-up and scale-up
ATMPs are different from traditional pharmaceuticals. Not only in the way they work but also how they are developed and produced. This requires companies to come up with new strategies for fast ramp-up and scale-up – a challenge that requires deep know-how of digitalization and automation. Low levels of automation and integration of equipment need to be replaced by integrated automation solutions, and manual, paper-based work calls for consistent digital solutions that are compliant to strict regulatory requirements.
Siemens offers a broad range of hardware and software solutions for R&D, production design and execution, and lifecycle intelligence and analytics to help biopharmaceutical companies of any size to bring cell and gene therapies to market faster.