- Enzene has initiated commercial supply of pertuzumab for HER2-positive breast cancer in India.
- The product is the fourth monoclonal antibody manufactured using the company’s proprietary fully-connected continuous manufacturing™ (FCCM™) technology.
Enzene, a global continuously innovative development and manufacturing organisation (CIDMO), has started the commercial supply of pertuzumab in India. The monoclonal antibody therapy, used for HER2-positive breast cancer, will be marketed locally by multiple pharmaceutical companies.
The therapy was developed and scaled to commercial readiness at Enzene’s biologics facility in Pune, which has received approval from the Drug Controller General of India (DCGI). Pertuzumab is the fourth monoclonal antibody brought to market through Enzene’s FCCM™ platform, which enables high-yield, cost-efficient, and sustainable production.
“The commercial supply of pertuzumab marks the latest milestone in our mission to help our partners expand patients’ access to high-quality, affordable biologics,” an Enzene official said.
Pertuzumab acts by blocking the dimerisation of the HER2 receptor with other HER receptors, inhibiting the signals that drive cell growth and proliferation. It is prescribed in combination with trastuzumab and docetaxel for HER2-positive breast cancer and also used as a neoadjuvant in early disease and an adjuvant for high-risk recurrence cases.
Enzene’s Pune facility is the first in its network to feature the EnzeneX™ 2.0 platform, designed to reduce equipment footprints compared with conventional fed-batch systems. It supports clinical-phase cGMP supply from 30 litres upwards, with adaptable capacity for scale-on, scale-up, and scale-out manufacturing, enabling integrated services across challenging disease areas and innovative therapies.
