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Enzene Announces Commercial Supply of Pertuzumab

Pertuzumab uses Enzene’s fully-connected continuous manufacturing (FCCM) technology.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Enzene has announced the 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 pharmaceutical companies.

Developed and scaled to commercial launch readiness at Enzene’s biologics facility in Pune, the product has received approval from the Drug Controller General of India (DCGI). Pertuzumab is the fourth mAb to reach commercial supply using Enzene’s proprietary fully-connected continuous manufacturing (FCCM) technology.

“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 dimerization of human epidermal growth factor receptor 2 (HER2) with other HER receptors, which prevents them from signaling 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 an adjuvant for patients with a high risk of recurrence.

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