Syngene International, an integrated research, development and cGMP manufacturing services company, has announced the expansion of its biomanufacturing capacity. The Company has set up and commissioned a new microbial cGMP facility and has also expanded the capacity of its mammalian cell manufacturing facility to extend end-to-end chemistry, manufacturing and control (CMC) development solutions for its global clients. Both facilities are located at its Biocon Park campus in Bengaluru, India.
The new microbial facility has two fermenters of 200l and 500l capacity. The microbial facility will provide further integration opportunities with the company’s existing Discovery and Development capabilities and extend service offerings in the space of GMP manufacturing of plasmid DNA and mRNA. In addition to this, another 2,000l single-use bioreactor will be added to the USFDA and EMA compliant mammalian manufacturing facility.
This is expected to strengthen Syngene’s service offerings for commercial supply. The expansion is building on Syngene’s existing biopharmaceuticals manufacturing capabilities and is aligned with its strategic focus on biologics as one of its future growth drivers.
Commenting on this development, Jonathan Hunt, Managing Director and Chief Executive Officer, Syngene International Limited said: “Our biologics manufacturing facility can handle multi-product production campaigns simultaneously based on our single-use technology platform, and we continue to build on our capacity year-on-year to meet the growing demand for outsourced biologics manufacturing. The recent investments have increased our production capabilities for bulk drug substances to meet the growing requirements from our expanding client base for end-to-end cGMP clinical and commercial manufacturing.
“The use of digitalization and automation tools such as electronic quality records and digital signatures will not only help avoid the risk of human errors but also decrease operational costs and improve time-to-market. Both the facilities are supported by proven processes for efficient, scalable, customized and regulatory-compliant commercial manufacturing.”
The global biologics market size is expected to reach $749.62bn in 2028 at a CAGR of 10.8% from 20211. The cancer segment accounted for the largest revenue share in the global biologics market in 2020, due to the increasing prevalence of the disease worldwide. In the last decade, the focus of new investments in the biologics sector has shifted toward mammalian cell culture due to the dominance of monoclonal antibodies. This has resulted in the need for microbial service providers worldwide, thus, there are emerging opportunities in microbial manufacturing, in particular antibody fragments and production of plasmids for gene therapy, as well as niche non-pharma applications.