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BASEL, Switzerland – The European Medicines Agency’s (EMA) newly formed Quality Innovation Group (QIG) aims to clarify regulatory expectations for innovative manufacturing technologies to help bring these products to market, and is looking in the areas of decentralized manufacturing, 3D technology, and continuous manufacturing, asserted Veronika Jekerle, EMA head of pharmaceutical quality at DIA Europe 2023.
At the meeting, Jekerle described the mandate of QIG, which was formed last September, and its activities to date.
She said one area where clarity is needed is for 3D printed bioimplants. These products include cartilage stem cells, lipid mediators and growth factors.
There are questions related to the biological starting materials of these products, and whether these bioimplants should be classified as a medical device or an advanced therapy medicinal product (ATMP); these questions are not addressed by existing guidance.
Companies also are interested in developing agile, or flexible facilities for biological manufacturing. These facilities consist of different manufacturing platforms for different active pharmaceutical ingredients (APIs). Manufacturers have questions on the regulatory strategy they should use to get these facilities approved, and guidance in this area is also limited.
The group includes eight members with backgrounds in chemical and biological assessments, including ATMPs. Their activities are coordinated with the Quality Working Party (QWP), the Biologics Working Party (BWP), the GMP Investigators Working Group (IWG) and members of academia. Stakeholders can submit a request to have their technology reviewed by the team. If accepted, a QIG expert primary assessor is assigned to review the technology.
The QIG also holds “listen-learn” focus group meetings where they review the challenges associated with certain innovative technologies.
At the most recent focus meeting held in March, the group discussed four industry case studies involving continuous manufacturing and decentralized manufacturing. There were 110 participants at the meeting, and included the QIG and the EMA secretariat, academia, and 20 industry associations, EU regulatory network experts, as well as representatives from Japan’s Phamaceuticals and Medical Devices Agency (PMDA) and the US Food and Drug Administration (FDA). A meeting report is slated to be issued on 13 May 2023.
Jekerle also noted there is confusion about the difference between the QIG and EMA’s Innovation Task Force (ITF). The ITF supports innovations that are more multidisciplinary in scope while QIG is more focused on manufacturing technologies.
Regulatory solutions needed for decentralized manufacturing
Gülbengü Yüksel, head of quality for Tigen Pharmaceuticals, a Swiss biotech that develops cell therapies for oncology treatment, reiterated that regulatory guidance is needed for decentralized manufacturing.
She said that patients can benefit from having cell treatments available at the hospitals and not have to travel to a centralized location. “Bringing manufacturing closer to the patient has the potential to accelerate the therapy.”
She said that “additional denaturalized regulatory guidance in the form of a Q&A document would be helpful to clarify regulatory expectations.” Specific questions relate to how to qualify decentralized manufacturing sites and how to demonstrate comparability.
(Source: Regulatory Focus)
