Enzene Initiates Commercial Supply of Pertuzumab
Using its fully-connected continuous manufacturing technology, the CDMO has developed and scaled up pertuzumab to commercial launch readiness for the Indian market.
Global CDMO, Enzene, has announced that it has started supplying pertuzumab, a monoclonal antibody (mAb) therapy used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer, at commercial scale. Having received approval from the Drug Controller General of India, the product marks the fourth mAb to have reached commercial supply using the company’s fully-connected continuous manufacturing technology (1).
Pertuzumab is a targeted cancer drug that is used in combination with other drugs (trastuzumab and docetaxel) and chemotherapy to treat HER2+ breast cancer, and works by binding to HER2, thereby preventing HER2 producing signals that cause cancer cells to grow (2,3). Given the fact that the prevalence of cancer is rising, driving growth in the global pertuzumab market (4), a secure supply of this drug product is increasingly important.
“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, in a company press release (1). “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.”
Development and scale up to commercial launch readiness of the drug product were performed at Enzene’s advanced biologics facility in Pune, India, which was the first site in the company’s network to feature its EnzeneX 2.0 platform. Earlier in the year (in March 2025), the company received European Union good manufacturing practice (GMP) certification at its two facilities in Pune to provide commercial-scale microbial and mammalian drug substance supply and drug product fill/finish and packaging services (5).
“The European Union’s GMP certification provides existing and potential customers with tangible evidence that Enzene meets the stringent quality and safety standards required by the European Medicines Agency, and marks another step on Enzene’s journey to providing comprehensive solutions to clients in Europe and beyond,” explained an Enzene spokesperson, in a company press release about the certification (5).
References
Enzene. Enzene Enables Commercial Supply of Pertuzumab for the Treatment of Breast Cancer. Press Release, Sept. 22, 2025.
EMA. Prejeta (Pertuzumab). EMA.europa.eu (accessed Sept. 25, 2025).
Zagouri, F.; Sergentasni, T.N.; Chrysikos, D.; et al. Pertuzumab in Breast Cancer: A Systemic Review. Clin. Breast Cancer, 2013, 13 (5), 315–324.
Global Growth Insights. Pertuzumab Market Size (USD 254.62 M) by 2032 by Types (Human Source, Animal Source), Applications (Hospital, Medical Center) and Regional Forecast to 2032. Market Research Report, Sept. 8, 2025.
Enzene. Enzene Receives EU GMP Certificiation for its Facilities in India. Press Release, March 4, 2025.