In order to tackle the serious health emergency caused by the COVID-19 pandemic, Kedrion's R&D department set to work immediately to develop potential therapies in the shortest possible time. In this respect, our efforts are concentrated on the use of “convalescent plasma” (donated by patients who have recovered from the disease, and rich in anti-virus antibodies) obtained through pathogen inactivation methods, and Immunoglobulin extracted from the plasma of patients who have recovered and are immune to the virus, produced on an industrial scale.
Kedrion Biopharma has provided this plan of action in order to tackle the serious health emergency caused by the COVID-19 pandemic.
In a statement, Dott. Alessandro Gringeri, Kedrion Biopharma Chief Medical and R&D Officer says: “There have been many diseases in the past which have benefited from this type of treatment. The success rate is very high, close to 90-95%. This has encouraged us to focus our resources and investments in obtaining in the short term a hyperimmune Immunoglobulin concentrate with a high content of specific SARS-COV-2 neutralizing antibodies, capable of counteracting the disease in patients with severe symptoms and, in the future, of blocking the development of symptoms both in patients who are already hospitalized with COVID-19 and in high-risk patients.”
“We at Kedrion have taken action immediately, conscious of the fact that plasma is a precious biological material, whose biochemical properties and therapeutic uses are largely unexplored; it has a huge potential, therefore, and we are convinced that in this instance it could be invaluable”, concludes Dott. Gringeri.
The same therapy has been used successfully to improve the survival rate in patients with equally serious acute respiratory syndromes caused by other coronaviruses, such as SARS and MERS, and to reduce the time spent in hospital.
As we await the start of industrial production results recorded from administering hyperimmune convalescent plasma to critical COVID-19 patients in a number of centers in Lombardy are very positive. In these cases Kedrion Biopharma provided and installed in record time devices capable of processing plasma from convalescent COVID-19 patients, through viral inactivation, and making it safe to administer to critically ill patients.
Transfusion centers in Mantova, Padova and Pisa (Italy) have received free equipment for this procedure, together with kits necessary for preparing 3.200 units of convalescent plasma. Those centers which already have the machinery are equipping themselves with the necessary kits for viral inactivation of plasma. An experimental clinical protocol has already been developed by the Service of Immunohematology and Transfusion Medicine of San Matteo Hospital in Pavia in collaboration with other structures such as those in Lodi and Mantova, and the University Hospital in Padova.
It will be possible to treat the more critical patients with this plasma.
In order to increase availability of convalescent plasma, main ally in the battle against this infectious epidemic, Kedrion Biopharma will provide the Italian Transfusion Service with its viral inactivation technology and the additional tests required, including the total neutralizing specific antibodies titer.
The procedure will be carried out at Kedrion’s Sant’Antimo (Naples, Italy) production site, where COVID-19 convalescent patient plasma will be tested for the presence of viruses transmissible via blood and treated with solvent/detergent (S/D) in order to eliminate all viruses. In the near future, once the test for anti-SARS-CoV-2 antibody titer becomes available at Transfusion Centers, it will also be possible to use plasma from COVID-19 asymptomatic patients testing negative to PCR.