After the announcement of MegaLab, IIT alumni council today announced MegaTx – an initiative to create an end-to-end indigenous biotherapeutics ecosystem targeting safe and effective treatments for Covid-19.
The primary funding vehicle for MegaLab and MegaTx is the Rs 21,000 crore MegaFund. MegaTx will design systems for mass collection and testing of blood donated by recovered C19 patients.
MegaTx will use existing industry capacity for large-scale manufacturing of intravenous immunoglobins from verified donor plasma.
MegaTx will alongside identify and characterize the antibodies for the treatment of C19 and to manufacture monoclonal antibodies (MAB) in adequate quantities using recombinant mammalian cell lines to stably express them. This scale of biotherapeutic manufacturing has not been attempted before in India.
IIT alumni council announced the MegaTx initiative to identify, optimize, and indigenously manufacture biotherapeutics for the treatment of C19. The Council has proposed a two-stage process.
The expeditious pathway will be using antibodies harvested from human plasma collected through blood donation camps that seek donors who have recovered from C19.
The subsequent stage involves identification and characterization of identified neutralizing antibodies for mass production using recombinant DNA technology: i.e. to manufacture and purify the antibodies from stable, high expressing recombinant cell lines.
The convalescent plasma therapy proposed at the NSCI Dome is the first step towards identifying and characterizing antibodies for the prevention and treatment of C19.
The plan is to identify and characterize the antibodies for the treatment of C19 and to manufacture the same inadequate quantity using recombinant mammalian cell lines to stably express them.
"The C19 Task Force of IIT Alumni Council had accepted the challenge to develop indigenous biotherapeutics in India to help save lives of those adversely affected by C19. We started off initially with the Platinae Open Source Stack which catalyzed successful clinical trials on plasma therapy. We are now taking a giant step and the MegaTx initiative will address the challenge of indigenously producing the required BioTherapeutics cost-effectively and administering them safely. This scale of biotherapeutic manufacturing has not been attempted in India," said Ravi Sharma, President and Chief Volunteer of the IIT alumni council.
"In order to meet the immediate need to save the lives of critical patients, we are proposing to harvest antibodies from blood donated by recovered C19 patients. Each donor can contribute around 25ml weekly or one unit of blood roughly every three months safely. The task at hand thus is to create the infrastructure to process around 50,000 liters of blood every month to extract relevant immunoglobins for intravenous administration. Convalescent plasma therapy is primarily suited for small patient populations; not something that is easily scalable for mass deployment. Therefore, investment in highly productive recombinant production systems is a must," added Dr. Arindam Bose, an IIT alumnus, Chairperson of Therapeutics Group of the C19 Task Force and a well-known expert in the area of BioTherapeutics product development and manufacturing..