Conference Report on GMP for ATMPs
On 26-27 June, 2019, the second ECA conference on GMP for Advanced Therapy Medicinal Products (ATMPs) was held in Vienna. About 100 participants from academia, industry, inspectorates and regulatory bodies were educated on the applicable guideline and discussed hot topics with respect to implementing these new GMP regulations and compliance to regulatory requirements.
The conference started with the results from a survey on these topics the ECA's Interest Group on ATMPs had performed at the beginning of the year. The survey was distributed to the conference participants who can point out the areas of the guideline from which they face the least or most challenges. The results will help the ATMP Interest Group to steer further activities.
The essentials of the current GMP guideline for Advanced Therapies Medicinal Products (ATMP), in force since May 2018, were presented in detail by Dr Rainer Gnibl from a German inspectorate. He explained important topics in detail with link to the respective guideline clauses as well as other applicable guidelines. The talks bridged guideline requirements to implementation in manufacturing routine, supported by Dr Gnibl's shared inspection experience. Special focus on the regulations the guidance gives for investigational ATMPs (iATMPs) and an outlook to US regulations were added by a talk prepared by Hiltrud Horn from Horn Pharmaceutical Consulting, Germany.
Two types of ATMPs were dealt with in depth. Ralf Sanzenbacher from PEI, the German regulatory body for Biologics, informed in a vivid talk on regulatory expectations for ATMP in general and specifically on tissues, tissue preparations and tissue engineered products (TEP), the latter being ATMP. Manufacture of this kind of products was covered by Marco Fadda from Comercer, Italy, who presented the development and implementation of a large scale GMP production plant for an EMA-approved cartilage substitute. Requirements on manufacturing of cell-based products, another class of ATMPs, under GMP and inspection experience were also provided by Ralf Sanzenbacher from PEI, Germany. Deeper insight into manufacturing and quality aspects of CAR-T cell products as one kind of cell-based ATMP was presented by Iris Bürger of Milteny, Germany, who discussed potential of automated manufacture in closed systems.
The importance and challenges of microbiological testing of ATMPs were explained by Antonio Rodriguez Acosta from the Andalusian Initiative for Advanced Therapies in Spain and by Thomas Meindl from Labor LS in Germany. Antonio Rodriguez Acosta gave some insight into microbiological safety testing, providing his results and learnings of implementing Pharm. Eur. monograph 2.6.27. He concluded his talk with an outlook on challenges of viral safety, especially for allogenic products, by infectious diseases. Thomas Meindl gave a comprehensive presentation on established microbiological methods as well as on alternative microbiological methods and rapid microbiological methods (RMM). He discussed the pro's and con's of these methods and the effort to be taken to reach regulatory compliance and acceptance. Analytical characterisation of ATMPs and related methods was described by Markus Fido from VelaLabs, Austria, who also provided scientific background of several example products.
In summary, the conference participants received first-hand information on the GMP for ATMPs guideline and the actual challenges manufacturers and inspectors face while implementing them. The many questions and lively discussions proved the relevance of the selected topics and quality of the talks, as did the concurrent publication of an EMA Q&A document on administration of OOS batches of ATMPs under certain conditions.
Authors:
Dr. Sabine Hauck
... works for Leukocare AG in Germany and is Chair of the ECA ATMP Interest Group.
Dr. Andrea Hauser
... works at the Universitätsklinikum Regensburg in Germany and is Vice Chair of the ECA ATMP Interest Group.
