Advanced Therapy Medicinal Products
Are you an advanced therapy medicinal products (ATMP) manufacturer looking for a way to manage your process and improve its outcome? Do you want to optimize testing costs and centralize the process from early development to submission and filing?
The QbD Group can offer your company support and solutions in regulatory affairs, quality assurance, QMS establishment, and process development thanks to our dedicated team of ATMP experts. Discover more on our ATMP expertise below.
Challenges in ATMP
The ATMP industry is a fast-growing field, which has gained high momentum in the last decade. Current US projections forecast a T-cell market growth from 2.38 billion USD in 2018 reaching 8.37 billion USD in 2027, with an annual growth rate close to 15%. The global cancer gene therapy market expects an annual growth rate of 32.5%. The same trend is observed globally. Several products have hit the market during the past years. Nevertheless, the processes within the ATMP industry create several challenges and room for improvement. The high regulatory requirements and the long development time that come along with handling living tissues and generating GMOs, translate into a raise in the final product costs. ATMPs are therefore often unaffordable for patients. Major efforts should be devoted to tackle these challenges.
The ATMP core team within the QbD Group consists of highly skilled professionals in the different aspects and steps of the ATMP product life cycle. Our experts in process development, manufacturing, quality control, regulatory affairs and quality management can help you in establishing and/or improving your product manufacturing and control strategy.
Furthermore, thanks to our Scilife software, we provide support in following the Quality by Design method to develop and/or optimize your process. This module, combined with our expertise, leads you through thorough risk analysis, a pragmatic approach in designing the required experiments, scaling out/up, and eventually manage the process costs by the means of a cost of good analysis.
The Quality by Design method is a methodology and a quality system to manage the product’s lifecycle. It is a multifunctional exercise, intended to increase process and product understanding and thereby decrease patient risk. The Quality by Design methodology is woven into the regulatory Guidance Documents (FDA, ICH).
The two critical starting points of the Quality by Design methodology are knowledge and risk. The decisions taken are based on the knowledge of the product and the process, followed by the risk assessment including all the key elements of the process: critical Quality Attributes (cQAs), critical Process Parameters (cPPs) and critical Material Attributes (cMAs). This systematic approach to process developments will lead to the design of a capable process, which can be implemented at any stage of the product’s life cycle. It will encourage continuous improvements and the risk assessment will be the base of the continuous process verification (CPV).
The QbD module, included in Scilife, is designed to take the user “by hand” through the application of the Quality by Design methodology: the definition of cQAs, cPPs and cMAs, mapping the process, and performing a double risk assessment to define a pragmatic process development approach to drive the development efforts toward the most critical parameters emerged from the risk assessment.
Master your ATMP development process
The QbD Module helps you resolve the abundant challenges currently faced in the development and production of a new ATMP. It enables you to opt for a quality-focused ATMP development process by executing risk-based process assessments.
The application of QbD Module 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.
Don’t hesitate to contact us so we can listen to your needs and provide you with the right services.