VLAIO awards subsidy to QbD for innovation in cell therapy process development20/03/2018 - Bart Van Acker, Founder/Managing Director at Quality by Design
Production of personalised medication can be significantly cheaper
VLAIO, the Innovation and Entrepreneurship Agency, awarded QbD and partner Antleron a project subsidy to develop their innovative platform for cell therapy processes. QbD and Antleron want to make the new platform the bridge between traditional medicine production and personalised medicines. The subsidy demonstrates that the Flemish government believes in the approach and vision of QbD and Antleron with respect to research and development in pharmaceutical biotechnology.
Currently, the therapeutic effectiveness of medicines is a function of the likelihood of success and the influence of a number of personal factors. Personalised medicine solves this by customising medical products to match a specific patient’s needs with respect to their predicted response and/or disease risk. Personalised medicine, including cell therapy, is becoming an increasingly satisfactory solution in treating complex, specific, or genetic diseases, such as cancer, Alzheimer’s disease, cardiovascular diseases, and mycobacterial infections.
The personalised nature of these therapies can be aligned with the unique needs of each patient. In contrast to traditional medicine, no single treatment is alike. However, the technical challenge is proportional to the therapeutic potential. For example, with traditional medicine, thousands of identical doses can be produced each day and it is straightforward to set aside doses for quality control. With personalised medicine, this is not possible as only one unique dose is produced that is intended solely for one patient. Moreover, there are also significant challenges on the production side as each production process must be uniquely individualised.
In their new project, QbD and Antleron want to expand the ‘Quality by Design’ methodology into production processes for cell therapies to facilitate the development of personalised medicines. The ‘Quality by Design’ principle involves continuous monitoring of the process with the use of mathematical models to safeguard the quality of the end products. Continuous risk analysis and quality monitoring of the product based on measurable parameters are paramount. Incorporating quality control early in the development phase of the production process safeguards the final quality control of the uniquely personalised product. It also safeguards the time saved during the production process, which leads to the patient being treated more quickly. Moreover, on the regulatory front, this approach provides the necessary flexibility to implement a personalised production process.
The following objectives have been defined for the project:
- Provide a solution for the current gap in quality control in personalised medicines: currently, most cell therapies cannot carry out quality measurements during cultivation of cells phase without destroying expensive therapeutic materials. The process also cannot be adjusted during production when needed.
- The use of ‘Quality by Design’ in cell therapy research ensures that biologists, scientists, and producers know that their products are of a high quality at all times. This minimises the need for quality control after production.
- The process saves time and money. This will help push down the cost of such medicines, which means more patients can be helped.
- Companies that develop cell therapies can use this innovative platform to translate laboratory results more quickly into clinical actions and to produce the medicine at lower audit and production costs. This will make customised medicine financially feasible and a great advantage in making the battle against complex, and often rare, diseases more affordable.
Unique partnership between QbD and Antleron
To change healthcare forever, Quality by Design (QbD) and Antleron are building a unique
ecosystem together. Antleron’s team and R&D perfectly match with QbD’s tools, skills and
network. By linking game-changing engineering to extensive quality management, the
partnership between Antleron and QbD will create a landslide in healthcare. As a result,
patients will finally receive the tailored treatments they deserve.