A biosimilar drug manufacturer is concentrating on process optimization to increase uptake of its products in lower-income countries. According to Jeffrey Hausfeld, MD, chairman of the board of BioFactura, his company has relied on intensified profusion, CO2 stripping, and metabolomic analysis to reduce costs and increase yields.
“With biosimilars, it’s cost that drives the market. Process optimization gives the best possible yield while having a minimal effect on potency and safety,” says Hausfeld who will be discussing how to fund biosimilar development at the Bioprocessing Summit in Boston next month.
As part of his talk, he will detail the optimization techniques that BioFactura has adopted to cut costs as, for example, intensified perfusion which, according to Hausfeld, uses more expensive culture media, but also produces higher yields.
The company has also adopted CO2 stripping to maintain the pH of the bioreactor without adding bio-carbonates that can affect the health of the cells. “From what we can tell, the CO2 doesn’t have any negative effects on the critical quality attributes of our product,” he says.
Role for metabolomics
Finally, they’ve analyzed cell lines with metabolomics to see how their productivity varies over time and, we’ve identified three supplements to improve productivity,” he says, adding that process optimization is best done after Phase I.
“Until Phase I, you tend to have a locked process,” Hausfeld explains. “Afterwards, you might realize how you can tweak without a major change that would raise the eyebrows of a regulator.”
Regulators look to make sure that a biosimilar product resembles the original drug. Too many variations, and they will expect costly clinical trials. Hausfeld also recommends that biosimilar manufacturers carefully record the steps they take to optimize processes during development. This, he says, can help companies more easily transfer their technology to a contract manufacturer for commercial-scale production.
“The complexity of tech transfer can be [a] major issue that people don’t always think about when developing drugs,” he says.
“There are nuances that occur during every bioreactor run, and the tech transfer process can take a long time and go astray if you don’t document what you do in a stringent manner,” he continues while also recommending that instructions sent to contract manufacturers be readable, understandable, and actionable, keeping in mind that there are lots of opportunities to ask questions and exchange information before beginning a manufacturing process.
