In biopharma time is money. The longer it takes to get products to patients, the more it costs and the longer it takes for the revenues to arrive. As a result, companies strive to accelerate all parts of the development process.
And production is no exception, according to Mark Witcher of Brevitas Consulting, who says facility design can have a significant impact on speed to market. “Flexibility translates into speed. The more flexible the facility, the faster products can be moved from development, preclinical, and early clinical to late stage clinical trials and launch,” he said.
Witcher contrasted the multi-product facilities (MPF) model with the traditional approach of using separate plants for each stage of scaleup.
“The age of tech transfer is coming to an end. Tech transfer only adds time, costs, and risks to developing new products,” he explained. “A highly flexible facility can use most of the same facility, equipment, and most importantly human resources to manufacture preclinical through launch manufacturing at whatever scale is required to quickly get the product developed.”
Speed-to-market is not the only factor. According to Witcher, multi-product facilities can help reduce the impact of product failure or financial hardship.
“Products come and go, start and stop for a wide variety of unpredictable reasons over their development lifecycle at a maddening rate. That uncertainty translates to high risks for an inflexible manufacturing facility,” Witcher added. “A flexible facility can adapt to a dynamic product development environment. The facility can also adapt to a company’s priorities. For example, in the event of a pandemic, new important product candidates can be introduced in days to support development and commercial manufacturing by removing or deprioritizing less important products.”
Stainless steel mind-set
The flexible facility concept is straightforward to understand. But setting one up may not be, explained Witcher, particularly for firms used to the traditional single-product model.
“The biopharma industry is not good at building flexible facilities because of its heritage of stainless-steel purpose-built facilities using low yield processes that translates into large, expensive facilities. Even relatively small changes in stainless steel designs can be expensive,” he pointed out. “Portable, single-use technologies with high-yield processes translates into much more flexibility for modifying process formats to adapt to different or evolving processes. However, the mind state created by purpose-built stainless-steel facilities seems to be persistent.”
Witcher cited ballroom facilities—in which the processes for several products are commingled into large spaces—as a flawed approach to flexibility.
“These facilities are much cheaper to build and easier to operate under steady state conditions [than multiproduct facilities],” he said. “However, they can be difficult to run if the process and products are changing and or operating problems occur. The obvious risks of higher up-front costs are easier to understand than the benefits of faster and more efficient product development. A ballroom would be a nightmare to run if the process’s size and products were changing.”
The vogue for multi-product facilities has implications for the contract manufacturing sector, Witcher continued.
“For a CDMO, the value of flexibility is likely to be a survival issue. Smart companies should select a CDMO that can take them all the way to the marketplace,” he said. “CDMOs are a risk mitigation strategy for risks associated with having to build the same resources internally. With tech transfer being minimized, that means the CDMO needs to handle the two issues [speed and risk handling] very efficiently.”
