IIT Alumni Council announces MegaTx - an initiative to create end-to-end indigenous BioTherapeutics ecosystem

mp_connect

Management Paradise Admin
After the announcement of MegaLab, IIT Alumni Council
announces MegaTx - an initiative to create 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 to design systems for mass collection and testing
of blood donated by recovered C19 patients. MegaTx to use
existing industry capacity for large-scale manufacturing
of intravenous immunoglobins from verified donor
plasma.

• MegaTx to 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.
Contact: Media Team
E: media@iitalumnicouncil.org
T: +1 650 9008833
M: +91 93155 21237
www.iitalumnicouncil.org
Twitter: @iitcouncil

IIT ALUMNI COUNCIL
MEGATX INITIATIVE TO TARGET SAFE AND SURE C19 TREATMENT PAGE 2

New Delhi, Jul 6, 2020: IIT Alumni Council announces the 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, we are 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.

IIT ALUMNI COUNCIL
MEGATX INITIATIVE TO TARGET SAFE AND SURE C19 TREATMENT PAGE 3

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. His
biodata is appended to this press release.

“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. His biodata is appended to this
press release.

"NSCI Dome, a facility used hitherto for rock shows and music concerts was
transformed within a space of 5 days into the first jumbo facility outside of a hospital
environment used to treat Covid patients . With the help of IIT Alumni Council we used
technology to overcome shortage of healthcare professionals needed to treat the
increasing number of patients in Worli which was one of India’s first red zones. We have
innovated right from the start , used AI , modularized remotely controlled ICU’s and
collected valuable data in doing so . We have treated over 1700 people inclusive of
cancer patients , pregnant women , those above 60 yrs. and with co-morbidities with an
impressive recovery rate of 74% at the dome . We have so far discharged over 1450
people with an extremely low mortality rate ( <.001% ). I am extremely excited that we
shall soon start convalescent plasma therapy at NSCI Dome to fine tune the Mega TX

IIT ALUMNI COUNCIL
MEGATX INITIATIVE TO TARGET SAFE AND SURE C19 TREATMENT PAGE 4

treatment protocol" Said Dr Muffazal Lakdawala, Chairman of the Doctors Group of the
IIT Alumni Council and In-charge of the NSCI Dome Covid Facility in Mumbai. His
biodata is appended to this press release.

About IIT Alumni Council

IIT Alumni Council is the largest global body of alumni, students and faculty across all
the twenty-three IITs and partnering Technical Institutes of Excellence Network
(TieNet). The IIT Alumni Council aspires to catalyse India’s technological renaissance.
Through its initiatives , IIT Alumni Council intends to act as a network and as a bridge
between various providers of knowledge, wealth, information, wisdom, ideas, expertise
and entrepreneurship to promote technological solutions to problems facing India
under its 100 global city initiative.

The C19 Task Force was set up in February 2020 by the Global Board of the IIT Alumni
Council to supplement and compliment the efforts of the central and state governments
in the fight against C19.The Council has rallied the considerable resources of the global
IIT alumni ecosystem to catalyse technological and financial interventions for the C19
battle. For more information on IIT Alumni Council, please
visit: www.iitalumnicouncil.org

IIT ALUMNI COUNCIL
MEGATX INITIATIVE TO TARGET SAFE AND SURE C19 TREATMENT PAGE 5

A distinguished Alumnus of IIT Roorkee, former Corporate leader and now full time
Philanthropist - Ravi Sharma plays an active role in global revitalisation and unification of
IIT alumni across countries, across IITs and across age groups. He is the President and Chief
Volunteer of the IIT Alumni Council and also leads the Institute Outreach & Branding
initiatives. The main deliverables of the Council are facilitating alumni networking,
fortifying Brand IIT and Brand India, catalysing alumni participation in nation building and
accelerating technological developments in key areas of our economy including start-ups,
manufacturing and digital transformation. The Council has six operating missions -
Alumni Networking (PanIIT Alumni) , Mentorship (PanIIT Institute), Social Venture funding
(PanIIT Fund), CSR Platform (PanIIT Foundation), a Thinktank (PanIIT Forum) a Biomolecule
Mega Incubator (PanIIT Incubator). The IIT Alumni Council is now actively engaged in
solving the corona crisis and has formed the C19 Task Force which has the participation of
over 20,000 alumni and includes Mumbai University and ICT Mumbai as institutional
partners. C19 Task Force initiatives include the 10 million tests per month MegaLab, the 50K
liters harvested blood per month MegaTx and Rs 21,000 crore MegaFund.

IIT ALUMNI COUNCIL
MEGATX INITIATIVE TO TARGET SAFE AND SURE C19 TREATMENT PAGE 6

Dr. Arindam Bose retired from Pfizer Worldwide Research & Development in 2016 after 34
years in leadership roles in bioprocess development and clinical manufacturing. Dr. Bose's
final position at Pfizer was Vice-President, Biotherapeutics Pharmaceutical Sciences with
responsibility for external sourcing, competitive intelligence and external influencing as
well as for executing the technical development plan for Pfizer's entry into biosimilars. He
is widely recognized as a Key Thought Leader in the biopharmaceutical industry. Dr. Bose
was elected to the US National Academy of Engineering for innovations in biologics
manufacturing. Dr. Bose currently provides consulting services in bioprocessing to several
start-up biotechnology companies including a part-time process development
management role at Akero Therapeutics. He received a Ph.D. in chemical engineering from
Purdue University, a M.S. from the University of Michigan, Ann Arbor and a B. Tech from
the Indian Institute of Technology, Kanpur.
Dr Arindam Bose has been a key mentor and coach to the engineered biomolecule initiative
of the IIT Alumni Council. He has advised the Council on a host of issues of both a technical
and techno-economic nature. He has helped conceptualise and plan the Rs 500 crore
Engineered Bio Molecule Mega Incubator (EBMI) which will include a phygital incubator,
100K square feet pilot plant facilities,, a 10 acre residential training campus, a BSL3
Laboratory equipped research centre and a 100 acre biologics manufacturing cluster for
biologics exports in the NCR Biologics ecosphere which includes AIIMS, CSIR IGIB, EBMI
training campus, EBMI SEZ, THSTI, ICMR, AIIA, Bibcol, DBT, DST and TDB. The
BioTherapeutics Task Force of the IIT Alumni Council has close to 100 PhD volunteers , most
of who are alumni of the IITs, ICT and MU.

IIT ALUMNI COUNCIL
MEGATX INITIATIVE TO TARGET SAFE AND SURE C19 TREATMENT PAGE 7

Ashish Chitnis has a BTech in Chemical Engineering from the Indian Institute of
Technology, Bombay and graduated in 1987. He did a MS in Chemical Engineering from the
University of Mississippi and has a MBA from the Texas A&M University. He has been
involved in senior technical roles in the pharma industry since inception and has worked
with industry leaders such as Glaxo Smithkline and Pfizer. He has led engineering and
construction projects, managed technical support services and supervised staff to set up
global scale projects.

He has spent a significant part of his career helping to build manufacturing plants for
the production of blood plasma derived products. He has been an active volunteer in
the Therapeutics group of the IIT Alumni Council and was the first to help us
understand and appreciate the impact of regulatory issues on convalescent plasma
therapy. These issues are primarily related to the ban on commercial purchase of blood
from donors and the consequent ban on products derived from donor blood.
He also helped the group understand the need for “virus sanitisation” of the blood using
processes other than chromatography and fractionation which were used by Indian
industry. It is based on his recommendation that the MegaLab architecture was
modified to carry out concurrent testing for viruses in donor blood using RTPCR. Also,
modifications were made to the Genetic testing protocol to enable a framework for
creating an antibody library and characterising the antibodies to examine if one could
clone part of the antibody in a cell line to get the full benefit of the antibody at a fraction
of the cost. This approach has lately been commercialised by some bleeding edge
companies in the sector.

IIT ALUMNI COUNCIL
MEGATX INITIATIVE TO TARGET SAFE AND SURE C19 TREATMENT PAGE 8

Muffazal Lakdawala is an eminent Indian surgeon and founder of Digestive Health Institute
by Dr Muffi, Mumbai, which is the first Indian Centre for Excellence in Bariatric Surgery. He
is the chairman of Institute of Minimal Invasive Surgical Sciences & Research Centre, Saifee
Hospital, Mumbai and the president of IFSO- Asia Pacific chapter. He serves as the Doctor
to the Vice President of India and his clients include a wide cross section of political and
other leaders.
He was awarded the first international centre of excellence designation by the US based
SRC (Surgical Review Corporation) Mumbai. Dr Lakdawala underwent training in Bariatric
Surgery with Raul Rosenthal, Cleveland Clinic, United States, 2006. He was also trained at
the Unit of Gastro Surgery, with Piet Pattyn from the University of Ghent Hospital, Belgium,
2005 and also underwent Training in Advanced Laparoscopic Colorectal Surgery with Prof.
Seon Hahn Kim, Seoul, 2004.
He is one of the only Indian surgeon to have demonstrated live surgery in almost every
Asian country. Till date he has performed the largest number of single incision sleeve
gastrectomy surgeries in the world. He is the first surgeon to conduct laparoscopic gastric
bypass in India.
Lakdawala has performed sleeve gastrectomy surgery on one of the youngest Indian patient
who is a 17-year-old boy. He has performed Bariatric Surgery on the heaviest man in Asia
of 285 kg in Tianjen, China. Since its inception, he has been the Chairman of the Doctors
Group of the C19 Task Force.
 
Top