INVESTING IN CLIENT COLLABORATION

DEVELOPMENT & MANUFACTURING SERVICES

Our development services support the journey of a molecule through pre-clinical studies, clinical development and commercialisation phases. The trust built with our clients over the development phase, along with the vast knowledge and experience gained through these processes, puts us in a strong position to partner our clients in the manufacturing stage. Our facilities can support the manufacture of developmental batches as well as commercial supplies of these molecules. We offer a wide array of scientific services, allowing our clients bring a molecule to market and are also investing in enhanced manufacturing capabilities to support higher production.

We have a state-of-the-art cGMP facility in Bengaluru to manufacture New Chemical Entities. The facility is designed to support multi-kilogram to hundreds of kilograms per batch of Intermediates and APIs for clinical trials. The current capacity can also support initial commercial supplies.


Biologics Manufacturing

We have a state-of-the-art cGMP facility in Bengaluru to manufacture New Chemical Entities. The facility is designed to support multi-kilogram to hundreds of kilograms per batch of Intermediates and APIs for clinical trials. The current capacity can also support initial commercial supplies. clinical trials & commercial supplies. We offer one-stop shop support for the development of antibodies and other protein-based products for pharmaceutical and life sciences industries.

While the demand for biologics is increasing at a brisk pace, globally there is a dearth of high quality and high capacity manufacturing facilities. We have invested in building state-of-the-art biologics manufacturing infrastructure to partner companies in this sector. A modern, disposables-based mammalian manufacturing facility with multiple 2,000L bioreactors and a microbial manufacturing facility were commissioned in FY18.

A modern, disposables-based mammalian manufacturing facility with multiple 2,000L bioreactors and a microbial manufacturing facility were commissioned in FY18.

Performance Review

The growth in development and manufacturing services during the year was driven by a strong performance in the chemical development segment as well as traction in biologics manufacturing.

We successfully partnered our client in conceptualising and developing paediatric sprinkles dosage form for their programme. The client has filed a formulations patent for this dosage form. We also achieved completion of development and clinical supplies manufacturing of a drug product for a client and obtained Medicines and Healthcare Products Regulatory Agency (MHRA) approval for Investigational Medicinal Product Dossier (IMPD) filed. First-in-human (FIH) study has been initiated.

During the year, we enhanced efficiencies, including faster turnaround time at our laboratory, through effective workplace management system. Our injectable development capabilities were strengthened to provide improved services to our clients. The integrated Chemistry, Manufacturing and Controls (CMC) development portfolio was also made more robust, a strategic initiative aligned with our goal to invest in partnerships. The oral solid manufacturing facility successfully cleared a USFDA with zero 483 and No Action Indicated (NAI).

In the Biologics business unit, we expanded our process development capabilities by adding major state-ofthe-art equipment. Our mammalian manufacturing facility demonstrated good momentum with confirmation of new orders for clinical supplies. We are witnessing considerable potential for undertaking long-term commercial supplies as well for our clients. The viral testing facility for establishing the safety of biological product also received confirmation of new orders. A significant milestone was winning our first client order in Australia for end-toend development and manufacturing of a novel monoclonal antibodies (mAb), thus expanding our business footprint in Asia-Pacific.

We are committed to partnering the nation towards becoming a global hub for strategic research and development in biotechnology. In this regard, we are proud to share that the Biologics vertical established a National Centre for Advanced Protein Studies (CAPS) at our Bengaluru facility. The Centre is funded by Biotechnology Industry Research Assistance Council (BIRAC), a government agency supporting start-up biotech companies in India. The facility provides access to high end protein characterisation to all Indian companies and academic researchers.

A significant milestone was winning our first client order in Australia for endto-end development and manufacturing of a novel monoclonal antibodies (mAb), thus expanding our business footprint in Asia-Pacific