Enzene has announced the initiation of commercial supply of pertuzumab, a monoclonal antibody (mAb) therapy indicated for the treatment of HER2-positive (HER2+) breast cancer.
The product will be marketed in India by multiple leading pharmaceutical companies.
Developed and scaled to commercial launch readiness at Enzene’s advanced biologics facility in Pune, the product has received approval from the Drug Controller General of India (DCGI).
It is the fourth mAb to reach commercial supply using Enzene’s proprietary fully-connected continuous manufacturing (FCCM) technology, which delivers high-yield biomanufacturing cost-efficiently and sustainably.
"The commercial supply of pertuzumab marks the latest milestone in our mission to help our partners expand patients’ access to high-quality, affordable biologics,” commented an Enzene official.
“Innovation is a core value for us and in developing and commercially validating the industry’s first fully-connected continuous manufacturing technology, we have once again demonstrated its potential to radically improve the affordability of and access to, important biotherapeutics."
Pertuzumab works by inhibiting the dimerisation of human epidermal growth factor receptor 2 (HER2) with other HER receptors, which prevents them from signalling in ways that promote cell growth and proliferation.
It is used in combination with trastuzumab and docetaxel for the treatment of HER2+ breast cancer and in the same combination as a neoadjuvant in early HER2+ breast cancer and as an adjuvant for patients with a high risk of recurrence.
Enzene’s facility in Pune was the first site in the company’s network to feature its fully-connected EnzeneX 2.0 platform, which reduces equipment footprints compared to conventional fed-batch systems.
It is capable of clinical phase cGMP supply from as low as a 30-litre scale, with variable bioreactor capacity to accommodate scale-on, scale-up and scale-out expansion.
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