IIT Alumni Council today announced a MegaTx initiative to identify, optimise 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 characterisation of identified neutralising 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 of 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 in adequate 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 catalysed 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 lives of critical patients, the task force is proposing to harvest antibodies from blood donated by recovered C19 patients. Each donor can contribute around 25 ml 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 litres 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, a 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.
“I have spent a significant part of my career helping build manufacturing plants for the production of blood plasma derived products. There is a need to use plasma derived immunoglobins in the short term by using existing industry capacity and to rapidly move to monoclonal antibodies (MAB) by either hiring or setting up biotechnology plants for the mass manufacture of the identified and characterised antibodies. Since India does not permit paid donors or commercial trade in blood products, it is very challenging to create a sustainable ecosystem based on human harvesting of antibodies alone,” added Ashish Chitnis, an IIT Alumnus and Project Lead for a leading global company in the plasma derivatives business.