Smart Equipment & Technology Selection: De-risk Your Monoclonal Antibody Scale-up Process

The scale-up of monoclonal antibodies (mAbs) from pilot to production is a well-established process, but opportunities to further de-risk and improve processes - using platform products and technology - are available today. Innovations in raw materials, equipment and single-use technology continue to emerge in response to high market demand. Technology choices and decisions should be considered very early in development to avoid obstacles and maximize efficiency, as the stakes have never been higher.

The time frame from research and development to commercialization is thought to take a decade or more; one study reports an average of about 10.5 years from discovery to the completion of clinical trials. Reported development costs vary, but studies have shown estimates of $1.1 to $2.6 billion per clinical trial, factoring in expenditures on failed trials.

Any delays during clinical trials incur significant additional costs, including subsequent sales, with potential losses of $600,000 to as high as $8 million per day. Strategies to avoid such delays and product loss are therefore critical.

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