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.

ATMP

Challenges in ATMP

HIGH REGULATORY REQUIREMENTS AND LONG DEVELOPMENT TIME

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.

Why QbD?

DEDICATED EXPERTISE AND SOFTWARE

The ATMP core team within the QbD Group consists of higly skilled people 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 QbD 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.

ATMP

The QbD 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 QbD methodology is woven into the regulatory Guidance Documents (FDA, ICH).

The two pillars of the QbD 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 QbD 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.

Contact us

TALK TO AN EXPERT

Don’t hesitate to contact us so we can listen to your needs and provide you with the right services.

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Cell by Design: Why a practical framework is key to the R&D process of any cell-based ATMP

Analytical method validation: A validated process control method to determine cell density

A quality-focused process development roadmap
for ATMPs