IDT Biologika successfully completes qualification phase for pandemic preparedness

Blog Post Date: Thursday 7 September 2023

Dessau-Rosslau, September 7, 2023 – On August 7, 2023, the Center for Pandemic Vaccines and Therapeutics (ZEPAI) at the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, confirmed to IDT Biologika that all conditions for entering the so-called pandemic preparedness phase have now been met. IDT Biologika was able to successfully implement the requirements set for the qualification phase. With this, manufacturing capacity for 80 million doses of vector vaccine per year have been secured for the contractual duration of at least five years.

IDT Biologika is one of five German-based pharmaceutical companies selected for pandemic preparedness by the German government. 3 May 2022 saw the signing of the pandemic preparedness agreement, followed by the beginning of the qualification phase.

The primary requirements of pandemic preparedness are the availability of critical supplier materials, manufacturing lines ready for operation and trained personnel on hand at all times. To achieve this, IDT drew up detailed plans, undertook investments and made extensive preparations to enable the swift and smooth commencement and continuation of manufacturing in the event of a pandemic.

The concept features an additional building for drug substance manufacturing, a high-speed filling line and an extra deep-freeze unit at the Dessau-Roßlau site, with these recently erected and commissioned.

The German government has established the pandemic preparedness agreements with the goal of securing fast and comprehensive vaccine supplies for the German population in the case of a pandemic. Under the terms of the agreement, IDT Biologika commits itself to undertake the manufacture of pandemic vaccines in Germany and to maintain the necessary production capacity on standby.

This ensures the prompt ramping up of the production of vaccines and fast response times in the event of a pandemic. IDT is subject to contractual specifications that it is required to fulfil over the course of the maximum two-year qualification phase before the status of pandemic preparedness is achieved.

After only 14 months IDT Biologika succeeded in concluding all preparations, submitting the documents for examination in good time. Following this examination, ZEPAI confirmed the admission of IDT Biologika to the preparedness phase on August 7, 2023.

Dr. Jürgen Betzing, CEO IDT Biologika:

“This is a major milestone for pandemic precautions in Germany. The German government is providing the population with swift access to medical care in the event of a pandemic, whilst this also underscores the capability of Germany as a pharmaceuticals location and boosts innovation. Because being prepared for an unknown pandemic over the course of the next five years requires the constant further development of processes, technologies, and expertise. However – and this is something we are especially pleased about – we are the first company to be awarded pandemic prepared status by ZEPAI. This is a great achievement by our team!”