Syngene expands biopharma-manufacturing capacity

The company sets up a state-of-the-art microbial facility; expands mammalian facility
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Syngene International 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 company said in a statement.

It also said that the new microbial facility has two fermenters of 200 litres and 500 litres 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 2,000-litre single-use bioreactor will be added to the US Food and Drug Administration (FDA) and European Medicines Agency (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, 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 substance to meet the growing requirements from our expanding client base for end-to-end cGMP clinical and commercial manufacturing.

Use of digitalisation and automation tools like 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, customised and regulator-compliant commercial manufacturing.”

biopharma facilitybiopharma manufacturingEMASyngene InternationalUS FDA
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