Bharat Biotech enters cell and gene therapy market with $75M production investment: reports

With a storied history in vaccine development, India's Bharat Biotech is shaking things up and answering the call of advanced therapeutics. 

Bharat has unveiled plans to set up its first cell and gene therapy manufacturing facility at the Hyderabad, India, life sciences cluster known as Genome Valley. The drugmaker will lay out around $75 million for the project, multiple local news outlets have reported. 

The move by Bharat represents (PDF) its foray from vaccines into cutting-edge regenerative and personalized therapies, the company said in a Mar. 20 press release. Although a specific date wasn’t disclosed, the 50,000-square-foot plant is expected to begin full operations with the finalization of regulatory approvals and the completion of a build-out phase.

Bharat currently has five products in its personalized medicine pipeline—two in cell culture and three in the gene therapy segment, the Hindu Business Line reported late last week, citing comments from Bharat's executive chairman Krishan Ella. The company is working on a range of CAR-T cell, CAR-NK cell and off-the-shelf gene therapies, Bharat's chief development officer Raches Ella added, as quoted by the Times of India. 

“Bharat Biotech, with its extensive experience and proven excellence in viral vaccine manufacturing, is uniquely positioned to master these complexities and produce human-grade vectors at the scale and consistency needed for clinical trials,” Krishan Ella said in the company's release.

Additionally, Bharat has revealed a new collaboration pact with the University of Wisconsin-Madison that has the potential to expand into commercial deals that include in-licensing. The company is also looking ahead to exporting and the potential of medical tourism in the cell and gene therapy segment.

Bharat popped up on the global radar in 2019 when it became the largest supplier of rabies vaccines in the world after acquiring Chiron Behring Vaccines from GSK in an all-cash deal. The price of the purchase wasn’t disclosed.

At the time, India-based Chiron Behring had just a single product in the rabies vaccine Rabipur, while Bharat Biotech was selling a Vero cell-based rabies vaccine, Indirab. The acquisition boosted Bharat's annual rabies capacity to 25 million doses.

During the pandemic, Bharat also rolled out a COVID-19 vaccine, dubbed Covaxin, which won approvals in multiple countries including India, Malaysia and Mexico. Attempts to introduce the shot in the U.S. with partner Ocugen proved less fruitful, however. 

Bharat currently boasts a portfolio of more than 19 vaccines and 4 biotherapeutics, with shots in influenza H1N1, rotavirus, Japanese encephalitis, rabies and cholera, among multiple others.