CPhI experts predict continuous manufacturing for all within 10-years

CPhI Worldwide, organized by UBM EMEA, today announces the findings of part ii of its 2015 annual report (titled: ‘Quality, metrics and continuous processing’) ahead of CPhI Worldwide 2015 in Madrid, with experts looking at the implications of “quality by design” (QbD), continuous processing, excipient criticality and process validation on pharmaceutical manufacturing.

The overall findings reveal there is now clearly a global commitment to move forward with the principles of QbD, however, the rate of adoption remains highly uneven. At the advanced end of the spectrum there are a limited number of Western manufacturers that are moving towards continuous processing. However, underestimating the complexity of both raw materials and finished products will continue to breed Black Swans, which could be particularly detrimental to continuous manufacture with real time release.

Emil Ciurczak, president at Doramaxx, believes that within 10-years all manufacturing globally will be continuous and it is only inertia and the fact that big pharma companies can still largely charge what they want in the USA that is preventing faster implementation; he warns that those manufacturers that fail to implement change early enough won’t see out the decade. The rate of adoption is now accelerating and he states we will see the industry’s leaders producing one or two products per year pace for the next several years, before only submitting New Drug Applications that include continuous manufacturing. He argues it will be at this point that we will see the biggest game changer, however, as the largest generics companies (Teva and Sandoz perhaps) start purchasing equipment. Following in their lead, the remainder of the market will quickly start investing. Overall, this could bring the cost of drug manufacturing down by as much as 50% if started at the development stage. He concludes that generic and orphan drug companies will see the greatest benefits.