Dr Reddy’s turns to single-use for biosimilar production in India
Indian drugmaker Dr Reddy’s Laboratories portfolio of biosimilar products includes versions of Aranesp (darbopoetin alfa), Neupogen (filgrastim) and Neulasta (pegfilgrastrim) and MabThera (rituximab) available on the Indian market.
And according to spokewoman Aparna Tekuri, the capacity expansion will support manufacturing of “all [its] cell culture based commercial products and future products in the pipeline.”
Currently the site in Hyderabad, Telangana has a total bioreactor capacity of 4,800L, comprised of four 1,000L and four 200L stainless steel systems, she told Biopharma-Reporter.
The expansion will almost double capacity, adding four GE Healthcare 1,000L single-use bioreactors expected to be operational in fiscal year 2019. Financial details were not divulged.
Single-use in India
The expansion marks the first installation in India of GE’s FlexFactory, its biomanufacturing platform incorporating single-use equipment and consumables, central automation, installation, and ongoing facility support and maintenance.
“[The platform] offers less unit operations, modularity and helps in faster deployment,” Tekuri told us. “GE has quite a few successful installations across the globe.”
Earlier this week, we reported news of fellow Indian biologics maker Stelis Biopharma partnering with MilliporeSigma to add single-use bioprocessing equipment at its site in Bangalore.
The firm told us disposable systems could help grow Indian biomanufacturing, a space which has not taken off in the country the same way as small molecule APIs and finished formulation, and GE Healthcare Life Sciences’ country manager for South Asia, Milind Palsule agreed.
“Single-use solutions have become very popular in the bioprocess industry, because biopharmaceuticals are increasingly being developed and then produced for smaller patient populations locally or regionally, targeting the unmet medical needs. This has changed the manufacturing requirements,” he told us.
“Indian Pharma companies are surely increasing their focus on biologics and many have built a strong pipeline of biosimilars,” he continued. “FlexFactory has generated a lot of interest in India, and we have a number of ongoing discussions with companies that are either looking at expanding their production or getting into this space.”