The biologics and API/intermediate plants in Bangalore and Mangalore respectively are compliant with leading regulatory standards and equipped with advanced technology to meet a full range of client requirements. Our fully integrated bio-manufacturing plant handles mammalian, microbial, yeast, and other expression systems. The API manufacturing facility has been designed to address complex chemical needs, working hand‑in‑hand with Development Services.
Our consistent investments in capability and capacity expansion enable us to offer faster, simpler, cleaner, and cost-effective manufacturing solutions complemented by quality assurance and quality control. We can play the role of partner for early-stage product launches, where speed to market is crucial, as well as being a commercial manufacturing partner for late-stage programs. For the latter, we leverage our expertise and technology to lower costs and optimize yields, addressing growing drug pricing pressures.
We delivered strong operational results in biologics, especially fulfilling global animal health company, Zoetis, contractual requirements for Librela®, an injectable monoclonal antibody that alleviates pain in canines with osteoarthritis.
In biologics development, we work on complex molecules for first-in-human use. Notably, we produced the first recombinant human plasminogen through significant process innovation, positioning us for a process patent. We also achieved a protein conjugation project milestone and demonstrated our capability for producing all required plasmids for lentiviral vector applications. Our mRNA production in GMP affirms our ability to expand into multiple therapeutic modalities.
The acquisition of Biofusion in fiscal year 2023 expanded our process development capabilities and led to valuable business expansion.
A significant development for the year was the acquisition of a biologics manufacturing facility adding 20,000 liters of installed biologics capacity and a commercial-scale fill-finish unit. The facility will be operational towards the end of 2024 after equipment upgrades and re-validation.
The 10-year manufacturing contract with Zoetis, signed in FY23, and other client contracts, quickly brought us close to full utilization of our existing biologics capacity. This acquisition replaces our internal plan for organic growth and provides capacity for future growth.
With the regulatory approval of our commercial API manufacturing facility from the US FDA, the facility in Mangalore now offers state-of-the-art manufacturing capacity for commercial manufacturing. It also obtained GMP certification in 2021.
The facility is automated, leveraging digital technology in GMP manufacturing, testing, and quality systems. It complies with CFR 21 Part 111 for data integrity and confidentiality. Furthermore, the facility demonstrates excellence in environmental stewardship with zero-liquid discharge, zero waste to landfill and recycling of all waste water at its offsite effluent treatment plant. Additionally, 66% of the energy consumption at the Mangalore campus is sourced from renewable sources.
