Biosimilars are expected to significantly expand the biologics piece of the industry, and companies headed along that pathway are intrigued by single-use, or disposable, technology they think can cut costs and provide flexibility.
Novartis ($NVS), which is building a $500 million biologics plant in Singapore, is going with a hybrid approach, Christopher Snook, who leads Novartis' Group Country Management, tells Contract Pharma in an interview. He says the company will use a mix of disposable technology and stainless steel placed in modules in an effort to get a high degree of repetition on design and automation. He says the platform for the production process is mammalian cell culture.
Snook says a quarter of the drugs in the Novartis pipeline are biologics and so the company needed enough volume to provide drugs for world-wide distribution, not just in Asia. He said the plant might also make biosimilars for Sandoz, the Novartis generic unit. "The uses of the site are in a state of constant evolution and will be a lot clearer as we come closer to the completion of this project," Snook said.
While single-use technology is still relatively new, biologics and biosimilar developers see great potential in it. Catalent's CDMO services in 2011 decided to move to disposable technology for its phase I and II clinical services work at a plant in Madison, WI, The facility, which will quadruple space, is replacing stainless bioreactors at a nearby facility. The company said it was drawn to the flexibility that single-use bioreactors provided, particularly for cleaning and change-over.
But the flexibility extends further than that says, Ganesh Kaundinya, chief scientific officer at biologics and biosimilars developer Momenta Pharmaceuticals ($MNTA). He explained in a recent interview that because disposable bioreactor technology offers the possibility of keeping manufacturing costs lower, it gives companies "enormous flexibility in the way they are committing their finances." They are able to use money longer for development before needing to invest in manufacturing.
- read the Contract Pharma interview
Special Report: Conquering the complexities of biologics to get to biosimilars