"APAC now leads global clinical development of multi-specific antibodies, accounting for over 40% of trials"

According to market projections, the biologics sector is expected to grow from $451 billion in 2024 to $938 billion by 2034, reflecting a CAGR of 7.6 per cent. While biologics, including vaccines, gene therapies, and monoclonal antibodies, offer targeted, effective treatments for cancer, autoimmune disorders, and rare conditions, these can be complex and costly to produce.

- Dr Manbeena Chawla

Focusing on this market trend, India-headquartered contract research, development, and manufacturing organisation (CRDMO) Syngene International has recently announced the acquisition of its first biologics site in the USA, fitted with multiple monoclonal antibody (mAbs) manufacturing lines. The overall investment in the US facility is estimated around $50 million, including the cost of acquisition ($36.5 million) and expenses to make the facility operational. To find out more about the company's plans for this acquisition and the current challenges facing the biologics market, BioSpectrum Asia spoke to Alex Del Priore, Senior Vice President – Development & Manufacturing Services, Syngene International. Edited excerpts:

What are the major plans in store after this acquisition? Is there a phase-wise plan?

Following the acquisition, Syngene has several major plans in store, many of which are already underway. The acquisition significantly expands our manufacturing capacity, increasing the total single-use bioreactor capacity to 50,000 L for large molecule discovery, development, and manufacturing. Hiring for the site is underway.

By adding a US-based facility to its global network, Syngene strengthens its geographic footprint and offers clients greater flexibility. The new facility complements Syngene's two existing biologics sites in India and its extensive bio-discovery services, providing an end-to-end solution from early development through to commercial manufacturing.

There is a clear phase-wise plan. Currently, the focus is on undertaking site enhancements and qualifying equipment, along with all necessary activities to make the site GMP compliant for mAbs. In the summer, Syngene will host key customers, stakeholders, and the press, with the facility expected to become fully operational for GMP manufacturing in the second half of 2025.