The ten members of the CoVIg-19 Plasma Alliance pool their knowledge and resources to accelerate the development of a potential treatment of COVID-19 and improve its chances of success. CSL Behring plays a central role as a founding member and co-leader of the alliance.
At the site in Bern Wankdorf, a hyperimmune – a plasma-based treatment therapy – is being manufactured for the pivotal Phase III clinical trial, the first test batch of which has already been successfully completed. In Bern, we are thus making a valuable contribution to the global plasma alliance and - in view of the ongoing global pandemic - to the whole world.
Hyperimmunoglobulins (HI) are highly concentrated antibodies in human plasma. They fight pathogens and other foreign substances. In the case of hyperimmune antibodies against COVID-19, the plasma used for manufacturing comes exclusively from fully recovered COVID-19 patients.
"This plasma contains antibodies that can neutralize the COVID-19 pathogen," said Michael Bieri, Director, Process Engineering Advanced Methodologies & Innovation at CSL Behring. "In our existing facilities and with our processes in Bern Wankdorf, these antibodies are processed into a so-called CoVIg-19 hyperimmune and delivered for clinical trials".
Race against time
The approval of a drug normally takes years and is only granted after the completion of clinical studies, which are divided into three phases. In phase I, the safety or tolerability of the drug is tested, followed by clinical trials to test its efficacy in the second phase, and in phase III the success of the treatment is documented.
In the case of HI against COVID-19, this process was accelerated. Since the hyperimmune process is based on the alliance partners' processes for immunoglobulins, safety did not have to be demonstrated. Thus, clinical phases I and II were skipped and the product was directly tested in phase III.
"A major challenge was to adapt the facilities in Bern to the manufacturing of the clinical product as quickly as possible. Thanks to an incredible collaboration of all departments we succeeded in a short time. We are spurred on by knowing that this product could potentially make a difference for the health of all people," Michael Bieri comments on the successes achieved so far.
In the coming weeks, four more clinical lots of the hyperimmune drug will be manufactured, so that the Phase III clinical trial can start as planned in August.
" A major challenge was to adapt the facilities in Bern to the manufacturing of the clinical product as quickly as possible. Thanks to an incredible collaboration of all departments we succeeded in a short time. "Process Engineering Advanced Methodologies & Innovation