The coming years, ATMPs (Advanced Therapy Medicinal Products) like cell therapy will undoubtedly gain in importance. However, production processes in this area are still labour-intensive, open and hardly automatized. There is clearly a growing need to make them more stable, robust and upscalable. In close cooperation with its innovative partner Antleron, QbD aims to answer to this need by ensuring that advanced therapy processes are closed and automatized.
In line with legal requirements from day one
Our approach takes all compliance requirements into account, which companies need to respect when launching their products. With cell therapy, it’s even more crucial that all legal boxes are checked from the very beginning, as the R&D process will in time become the production process.
Personal solutions leading to specific processes
Furthermore, we will focus on the small scale of cell therapy, which breaks with the tradition of large-quantity manufacturing. Until now, small processes within R&D were usually translated to large-scale production through upscaling and tech transfer. With cell therapy, every solution is produced for one single patient – or a very small group of patients – so that it is not only small-scaled, but also truly personal.
As a result, some specific processes – such as logistics – will become vital in cell therapy. From the beginning, it will need to be clearly defined how cells will be obtained and how they will return to the patient, once their modification has been established.
In this regard, we need to take the characteristics of two types of therapies into account. In autologous cell therapy, stem cells are harvested from the patient. When the cell culture has been expanded ex vivo to large quantities, it is then returned to the patient. In allogeneic cell therapy, stem cells are harvested from a single donor. When these cells have been cultured, they provide treatments to large numbers of patients.
Backed by ample expertise and the drive to go the extra mile, QbD and Antleron join forces to develop the specific processes that advanced therapies require. To realize this, we will apply our broad compliance knowledge of GMP, GDP, GLP and ISO13485.
Partnering with QbD
- We enable you to set up a Quality System in line with FDA and EMA regulations. Moreover, our wide range of technological solutions has been specifically developed to support your QA processes.
- You can rely on our QP services for the release of your product. We have all the tools in place to approve your batch records – even remotely, if needed.
- We also have the knowledge and experience to transform your manual steps into automated and closed processes.
- We have the expertise to validate and qualify your equipment and (automated) processes.