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Abstract
Advanced Therapy Medicinal Products (ATMP) provide promising treatment options particularly for unmet clinical needs, such as progressive and chronic diseases where currently no satisfying treatment exists. Especially from the ATMP subclass of Tissue Engineered Products (TEPs), only a few have yet been translated from an academic setting to clinic and beyond. A reason for low numbers of TEPs in current clinical trials and one main key hurdle for TEPs is the cost and labor-intensive manufacturing process. Manual production steps require experienced personnel, are challenging to standardize and to scale up. Automated manufacturing has the potential to overcome these challenges, toward an increasing cost-effectiveness. One major obstacle for automation is the control and risk prevention of cross contaminations, especially when handling parallel production lines of different patient material. These critical steps necessitate validated effective and efficient cleaning procedures in an automated system. In this perspective, possible technologies, concepts and solutions to existing ATMP manufacturing hurdles are discussed on the example of a late clinical phase II trial TEP. In compliance to Good Manufacturing Practice (GMP) guidelines, we propose a dual arm robot based isolator approach. Our novel concept enables complete process automation for adherent cell culture, and the translation of all manual process steps with standard laboratory equipment. Moreover, we discuss novel solutions for automated cleaning, without the need for human intervention. Consequently, our automation concept offers the unique chance to scale up production while becoming more cost-effective, which will ultimately increase TEP availability to a broader number of patients.
Highlights
Advanced Therapy Medicinal Products (ATMP) are at the forefront of current state of the art medical science and technology
We observe from experience, that the latter is introduced far beyond the point of product development, in late stages of testing which makes it difficult to develop a platform that is adaptable to all needs of the product manufacturing
We propose to keep the concept of automation always in mind when initially developing a manufacturing process to ease initial implementation, and to avoid unnecessary expenses for product revalidation [35]
Summary
ATMPs are at the forefront of current state of the art medical science and technology. Our current ATMP manufacturing protocol and the concept for the automated platform incorporates invasive sampling procedures prior to product release and manual scoring to ensure high product standards to pre-defined quality criteria. The automated visual inspection of histological tissue engineered cartilage using a modified Bern score and deep learning algorithm has already been demonstrated to be a feasible method for the prospective evaluation and graft release in a clinical manufacturing setting [31, 32] These pivotal procedures would greatly benefit from the implementation of non-invasive in-process controls, enabling real-time quality control and monitoring of product specifications throughout the manufacturing process. With product data sets from continuous monitoring, in-silicopredictions could allow a near real-time release of TEPs matching individually scheduled dates for surgical procedures, without the risk of delay due to product inconsistencies
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