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Pharmaceuticals Pharmaceuticals

PLANT COMMISSIONING ADVANCING MODERN THERAPEUTICS
Aragen’ Bengaluru biologics facility to begin THSTI hosts symposium on ‘Discovery and

making fi rst GMP batches in July development of monoclonal antibody therapeutics’

Aragen, a Hyderabad-based con- CHO-DG44 cell lines,” commented The Translational Health Science between industry and academia, start- clusters, he added, would serve as
tract research, development and manu- Subodh Deshmukh, CEO, Biologics and Technology Institute (THSTI), ing from the earliest stages of innova- fertile ground for training skilled per-
facturing organisation (CRDMO), will and President, Development, Aragen. under the aegis of the Department of tion and discovery, to develop afforda- sonnel and that symposia like this are
commence GMP manufacturing at its Biotechnology (DBT), Government ble and indigenous technologies. instrumental in uniting professionals
biologics manufacturing facility in Jamie Cascio, AVP, Biologics, added, of India, recently hosted a symposium from diverse sectors.
Bengaluru from July 2025. “With cutting-edge infrastructure and on the Discovery and Development of In his welcome address, Prof. Jayanta
deep technical expertise under one Monoclonal Antibody Therapeutics Bhattacharya, Dean, THSTI, empha- Dr. Alka Sharma, Scientist H and
The company said it has success- roof, this facility is designed to seam- at its campus in Faridabad. This event sized the critical importance of early Senior Adviser, DBT, underscored
fully completed the facility and equip- lessly support our partners from early brought together leading experts from collaboration between industry and the pivotal role of mAbs in precision
ment qualifi cation and demonstrated “This provides fl exibility to run multi- discovery through to commercial manu- the pharmaceutical industry, start-ups, academia at the innovation and discovery medicine and reaffi rmed DBT’s full
the productivity of its intensifi ed fed ple client projects in parallel or quickly facturing.” CRDMOs, various funding organi- stage. He highlighted that such partner- commitment to their development. The
batch cell culture manufacturing plat- scale up a customer’s production to zations (such as BIRAC, Wadhwani ships are vital for developing indigenous Bio-E3 (Biotechnology for Economy,
form to deliver titers over 25 g/L. commercial quantities,” the company The facility complements Aragen’s Foundation), to explore innovative and affordable technologies, which can Environment & Employment) policy
informed in a press note. existing biologics capabilities in Mor- models for advancing monoclonal signifi cantly benefi t the nation. of DBT, she said aims to catalyse bio-
According to Aragen, the facility gan Hill, California and together will antibody (mAb) therapies in India. technological self-reliance by invest-
has the fl exibility to house multiple “Our fi rst customer programme offer integrated services including cell Prof. G. Karthikeyan, Executive ing in advanced platforms like mAbs
2-KL single use bioreactors, set up will progress to GMP production as line development, process & analytical ‘Enhanced collaboration between Director, THSTI, further elaborated to combat diseases and strengthen local
for both fed-batch and intensifi ed fed- early as late July this year. The Ban- development, QC and GMP manufactur- industry and academia’ on India’s signifi cant contributions to R&D capacity, reducing reliance on
batch production and can deliver one galore manufacturing facility will help ing of monoclonal antibodies, biosimi- The symposium underscored India’s the fi eld of monoclonal antibodies. He imports and ensuring equitable access
batch every 4-5 days at full capacity. seamless transition to GMP manu- lars and other recombinant proteins. The burgeoning biopharmaceutical sector noted that the current moment is criti- to high-quality biologics.
The bioreactors are confi gured with facturing using not only intensifi ed California site already provides non- and the immense potential for indige- cal, with supportive policies in place,
multiple 2-KL units feeding into a fed-batch production, but also, our GMP manufacturing for batches from nous innovation in this critical area. A but stressed the imperative to establish The symposium featured a series
single downstream purifi cation suite. proprietary high-yield CHO-GS and 1-L to 50-L across six separate suites. key highlight of the discussions was the clusters where academia and industry of presentations from various industry
urgent need for enhanced collaboration can converge and collaborate. These players actively engaged in mAb R&D.
RECOMBINANT HUMAN ALBUMIN
Shilpa Medicare inks commercial supply deal Kirti Ganorkar appointed MD of Sun Pharma

with Finland’s Orion has announced the appointment of has been leading Sun Pharma’s across business development, market-
Sun Pharmaceutical Industries Ltd. of growth for the company. Mr. Ganorkar in 1996, he has held several key roles
KirtiGanorkar as Managing Director, India Business since June 2019. A Sun ing, M&A, project management, intel-
Shilpa Biocare, a Karnataka-based Orion will gain exclusive rights to effective September 1, 2025. He will Pharma veteran who joined the company lectual property, and litigation.
CDMO and fully-owned subsidiary distribute, market and sell Shilpa’s re- take over the role from Dilip Shanghvi,
of Shilpa Medicare, has secured combinant human albumin in Europe, marking a key leadership transition at Zydus receives EIR for Dabhasa
a Europe-wide commercial supply with Shilpa receiving development India’s largest pharmaceutical company.
agreement with Finland-based Orion and regulatory milestone payments All business and functional teams API manufacturing facility
Corporation for recombinant human from Orion. will report to Ganorkar following the
albumin. appointment. Ahmedabad-based located at Dabhasa
“This alliance aligns with our pharma fi rm, Zydus near Vadodara, Gujarat.
Shilpa’s recombinant human mission to provide high-quality, affor- While stepping down as MD, Lifesciences, has in- This facility underwent
albumin – a key plasma protein used dable biologics globally, and we are Mr. Shanghvi will continue to serve as formed that it has an inspection from
in various therapeutic applications – is and virus-free production, addressing confident this partnership will fur- Executive Chairman, leading the Board received the EIR April 21-25, 2025 and
currently under development and will some of the key limitations associated ther accelerate our footprint in the and focusing on the company’s long- (Establishment Inspec- has been classified
be manufactured using a non-human with human-derived albumin. regulated markets,” said Madhav term strategic direction. He will also tion Report) from the as Voluntary Action
expression system. This is expected to Bhutada, Managing Director, Shilpa play a pivotal role in expanding Sun USFDA for the inspection conducted Indicated (VAI). FDA confi rmed the
provide improved safety, scalability, Under the terms of the agreement, Biocare. Pharma’s specialty portfolio, a key area at its API manufacturing facility inspection as “closed.”

136 Chemical Weekly June 24, 2025 Chemical Weekly June 24, 2025 137

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