Considerations for the chemistry, manufacturing and Controls (CMC) - quality package for COVID-19 vaccines- interim lessons learnt by the European medicines Agency (EMA)

Regulatory Highlights

“…The iterative process through which the guidance was developed, with extensive input form industry and through consultation with FDA was noteworthy, as was (of course) that finalization of the guidance encompassed the transformative period of COVID-19 and the development of the COVID-19 therapies and vaccines. 18 Indeed, it can be argued that the principles and approaches developed in the aforementioned workshops and the draft guidance were instrumental in enabling the rapid development and supply of COVID-19 related medicinal products, and that the experience of the pandemic have shaped the final version of the toolbox.…”

Central Nervous System Gene Therapy: Present Developments and Emerging Trends Accelerating Industry-Academia Pathways

“…This is combined with the challenges of increase in scale as the number and range of treatments begins to grow exponentially (reviewed for AAV in 56 ). However, there are potentially valuable lessons from the COVID vaccine manufacture, which may be translatable to large scale good manufacturing practices (GMP) manufacture of other gene and cell therapy treatments 57 . Even with potential improvements, the costs of development and treatment remain a concern, with one estimate that by 2034, 1.09 million patients will be treated by gene therapy with a total cost of $306 billion 58 .…”

Übersicht über die in der EU zugelassenen COVID-19-Impfstoffe – von der Technologie über die klinische Prüfung zur Zulassung

“…Im Rahmen des Rolling-Review-Verfahrens erfolgt die Bewertung und Klärung von Fragen zu den Datenpaketen nicht auf der Basis eines kompletten Pakets von klinischen und nichtklinischen Daten, sondern von nach und nach eingereichten Datenpaketen durch Rapporteure und Co-Rapporteure (federführende Gutachter aus 2 Mitgliedstaaten) des CHMP [ 44 ]. Dies bedeutet, dass die Bewertung von nichtklinischen Daten und Daten zur Herstellung und Qualität bereits erfolgen kann, bevor die klinischen Daten aus den Studien vorliegen.…”