A quality – focused process development roadmap for ATMPs
Advanced Therapy Medicinal Products (ATMPs) are becoming a reality, and they have the potential to revolutionize the biotech industry.
However, of all ATMPs that have been authorized for the European market, forty percent has already been withdrawn and none have lasted more than five years, which is a worrying trend. If we want to ensure sector viability, something needs to change. Cell by Design ® (CbD), a cloud-based software platform that facilitates scalable, cost effective and sustainable ATMP process development, can help.
CbD focal points
The backbone of CbD is a quality-focused process development roadmap. Risk-based process assessments guide science and data-driven decisions in order to meet all pre-defined critical quality attributes of the ATMP. In addition to quality, manufacturability and scalability of the developed product and process are also key in CbD. Therefore, this is taken into account right from the start of a development trajectory, to ensure a hundred percent closed and automated process.
Finally, cost effectiveness is highly valued by CbD. E.g. QC often makes up a significant part of the manufacturing costs. By using Cell by Design, it is possible to build a design space of the process and product and to apply cheaper parametric releases.
The above is captured in an intuitive cloud-based software platform that is compatible with Industry 4.0 standards (remote monitoring & control and efficient data capturing and storage). This way of working facilitates process automation and allows for the implementation of machine learning methods and predictive modelling. The platform is in accordance with ATMP EMA documentation and it is 21CFR part 11 compliant.
By combining the strengths of both companies and optimizing and developing biotech production processes (Antleron) and QA, regulatory affairs and validation in life sciences (QbD), Cell by Design was born.
How can Cell by Design help you?
The application of CbD can be tailored to your specific needs. It can range from a close collaboration (in which you have full access to the software and can count on specialists’ advice in process development and in regulatory challenges) to any particular support you need for your specific ATMP product to process.
If you have any questions concerning ATMPs and you think CbD can support you, don’t hesitate to contact us for a chat or a demo about Cell by Design.