Patient-specific drugs are a challenge for current manufacturing facilities says an academic who predicts that in the future flexible tech and non-traditional sites will play a greater role.

Like the small-molecule pharmaceutical industry, biopharmaceutical manufacturing is based on volume production. The idea is that using a large, centralized facility to make significant quantities of product minimizes manufacturing costs.

But patient-specific medicines do not fit this model, which is forcing industry to innovate, says Daniel Bracewell, PhD, professor of bioprocess analysis at University College London (UCL).

“Personalized medicine is extremely disruptive to the model of a blockbuster molecule produced in centralized facilities. The ultimate incarnation of personalized therapy is CAR-T cell therapy and we are struggling to establish manufacturing and supply chains to economically deliver on their promise,” he tells GEN.

“It is a trend that is set to continue however as our knowledge of the biology of disease grows. At UCL we have supported by the Engineering and Physical Sciences Research Council (EPSRC) to establish a Hub in the area examining possible manufacturing and supply chain solutions.”

The idea is to develop manufacturing and supply chain models needed for the production of personalized—or targeted therapies. Bioprocess 4.0 technologies will be key to these solutions, Bracewell says.1

“An increase in the diversity of scales and types of products facilities will be required” he continues, adding “therefore the trend that emerged 5 to 10 years ago of designing flexible facilities using ballroom concepts and mobile and where possible disposable equipment will come under strain.

“Using modular construction to design these facilities can further increase flexibility and the ability to respond to these changing needs.”

Patient-specific facilities?

Ultimately, the most effective way of making personalized medicines may be a move away from the manufacturing facility altogether.

Bracewell explains that “if as predicted personalized and stratified approaches to medicine lead to the need for a greater array of products, many for a relatively small number of patients, a radically different approach to the manufacture and supply of biological products may be needed.”

“This raises the question whether the manufacturing of medicines could return to pharmacy or ultimately to the bedside.”

Innovation in personalized medicines production is likely to feed into the wider sector according to Bracewell, who adds that single-use technologies geared to smaller volume production have potential application in protein biomanufacturing, particularly in downstream operations.

“In the area of monomer protein products—classically mAbs—a certain level of maturity in terms of downstream processing (DSP) technology has been reached. Though we have not seen same switch to disposable technology we have seen in many areas of upstream processing,” he says.

This is because the cost of an affinity chromatography resin means something of the order of 100 cycles is required to make good on the investment.

“The advent of rapid cycling technology with convective chromatography media looks set to change this meaning those cycles can be achieved in one day rather than months,” says Bracewell. “This means the affinity chromatography resin becomes disposable in the same way upstream bioreactors can be. Hence the long-held goal of disposable based flexible facilities becomes much more readily achieved.”



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