A “can-do” attitude toward monoclonal antibody (mAb) production developed over the last 30 years has set the groundwork for rapid progress in advanced therapies.
That’s the view of Paul Varley, PhD, senior vice president of development at Alchemab Therapeutics, who gave a keynote speech on this topic at the recent Bioprocessing Summit Europe.
According to Varley, who has worked in mAb development and manufacturing for decades, mAbs were initially seen as a lost cause as medicines due to an inability to make them quickly, efficiently, and at low cost.
But today, more than 150 antibodies have hit the market, he says, and he believes that gene and cell therapies are at an early point in the same path.
“We’ve had this very long journey,” he says, “[historically] people thought [mAbs] could be great drugs but were practically not possible.”
“It’s a great message to send to the conference that, even now, we’re producing better antibodies because, with bright, energetic, and intellectual young people put to the task, we will find a way.”
According to Varley, manufacturers of promising advanced therapies, such as CAR-T, can learn a lot from the history of developments in the antibody space.
“If you look at viral therapies or CAR-T, these are amazing technologies with huge promise to further transform medicine, but they’re seen as having restricted applications because of similar issues to [early mAbs],” he explains.
Varley believes developments in mAbs that led to faster production, such as better process analytics, are happening even faster in the advanced therapy space.
“I’d argue strongly that it’s due to a can-do attitude because we’ve been there, done that already with mAbs,” he says.
Industry insiders are now applying their mAb experience to these new therapies, he says, and the regulators are also increasingly taking more flexible approaches.
“Regulators used to be quite conservative because they didn’t understand what was needed to make a therapy safe, but they’re now taking a more risk-based approach based on the needs of patients.”
His talk also covered the future of antibodies, including the development of new classes of drugs, such as antibody-drug-conjugates.
As a senior vice president at Alchemab, he says he’s now working to develop new, more developable antibodies based on studies of patients with natural resistance to disease.
