"We have expanded our discovery chemistry operations significantly in both Bangalore and Hyderabad, and now have a team of 1,400 discovery chemists. In addition to two vivariums (Hyderabad, San Francisco) that support our team of around 125 biologists, we are building a third vivarium in Bangalore."

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Manni Kantipudi & Dr. Ramesh Subramanian

CHIEF EXECUTIVE OFFICER & CHIEF COMMERCIAL OFFICER, GVK BIO

July 21, 2020

Can you give insights into the strategy and business model of GVK BIO?

We call ourselves a CRDO (Contract R&D Organization) to differentiate our mission. By singularly focusing on the area of R&D, and by having no competing interests with our customers. We partner with firms interested in externalizing R&D to drive value. We support our customers from concept to commercialization in small molecules, while assisting in their journey from gene to clinic in biologics. Our team is agnostic towards geography; we invest where the science is best. Case in point, to build a differentiated biologics platform, we opted to acquire Aragen BioSciences, a company in the San Francisco area, as opposed to building the capability in India. Aragen were leaders in cloning and expressing challenging proteins, a capability that was of high interest to our customers.

What are GVK BIO’s expansion plans both in the US and globally?

For small molecules, we are principally focused on our Indian sites for expansion. We have expanded our discovery chemistry operations significantly in both Bangalore and Hyderabad, and now have a team of 1,400 discovery chemists. In addition to two vivariums (Hyderabad, San Francisco) that support our team of around 125 biologists, we are building a third vivarium in Bangalore. Chemical development and manufacturing now has two independent sites in Hyderabad and Vizag with over 280 kL capacity. The GVK BIO team is proud to support over 10 IND filings every year, and over 60 chemical development programs.  In addition to drug substance, we have invested in a state-of-the-art formulation development center that assists customers in pre-formulation and formulation development, including parenterals, solid orals, opthalmics, liquids, semi-solids and suspensions. Finally, we are happy to announce that our analytical solutions facility was recently approved by the FDA and supports method development, stability studies, extractables and leachables, among others.

On biologics, we have added suites to our large molecule operation in San Francisco, augmenting our capabilities in both cell line development (CLD) and bio-production. Our CLD business has seen rapid growth this year (over 50%), primarily due to our expertise to clone and express difficult proteins. We have now decided to invest in cell culture manufacturing suites. This will allow seamless scale ups of our CLD programs, reducing both lead time and costs.

How has the acquisition of Aragen Bioscience expanded GVK BIO’s capabilities?

GVK BIO, prior to Aragen, was primarily a small molecule company. The acquisition propelled GVK BIO’s entry into biologics, the fastest growing segment in the life sciences industry. With over 25 years of history, Aragen has been a standout biologics CRO with a phenomenal track record. Three of Aragen’s programs for partners have now advanced into commercialization and are now medicines. This emphasis on science has made Aragen an attractive choice for GVK BIO partners worldwide that are interested in large molecule research. We are now levering Aragen’s expertise by building Aragen India: this center is currently supporting bio production and will soon advance into higher value services.

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