Over time, advances in manufacturing technologies have prompted pharmaceutical companies to shift from the traditional multi-step, batch manufacturing processes to faster and relatively efficient continuous manufacturing. Continuous manufacturing, also known as continuous flow chemistry, is an advanced manufacturing technology, which drives operations in a continuous manner (24×7) in one facility, without hold times. The concept was first described in the 1700s, for the production of pig iron in blast furnaces. Since then, the technique has been adopted by various industries, including automotive, food and beverage, oil refining, chemicals, pulp and paper, electronics, metal smelting, steel making, and waste-water treatment industries.
In recent years, continuous manufacturing has gained traction in the biopharmaceutical industry as well, having captured the attention of big pharma players, as well as leading contract manufacturing organizations (CMOs). Moreover, the ongoing COVID-19 pandemic has prompted the pharmaceutical industry to shift to continuous manufacturing to scale up processing. The continuous manufacturing technology offers several benefits, including reduction in manufacturing cost (by 15-30%), manpower (by 50-70%) and power consumption (by 40%), lesser product deviation (by 50%), smaller footprint (by 50-70%) and faster scale up. Specifically, for biologics, continuous manufacturing, through upstream perfusion, is already a well-established method.
In fact, more than 20 biologics manufactured using this approach have been approved by the FDA. Moreover, continuous processing technology presents a versatile and beneficial manufacturing approach for oral solid dosage (OSD) forms and small molecules as well. In the last few years, many orally administrable drugs, including TRIKAFTA® (Vertex Pharmaceuticals, 2019), DAURISMO™ (Pfizer, 2018), SYMDEKO® (Vertex Pharmaceuticals, 2018), VERZENIO® (Eli Lilly, 2017), PREZISTA® (Johnson & Johnson, 2016) and ORKAMBI® (Vertex Pharmaceuticals, 2015) manufactured using the continuous technique, have been approved by the FDA.