TABLETING 71
out-of-specification product is vanishingly small. Earlier in 2016, for example, the US Food and Drug Administration approved a CM process at Janssen’s facility in Gurabo, Puerto Rico, for the production of its HIV drug, Prezista. “Although it’s not easy
for drug manufacturers to transition from batch to continuous manufacturing, there are significant rewards,” commented Lawrence Yu, FDA’s deputy director for the Office of Pharmaceutical Quality, adding: “FDA encourages others in the pharmaceutical industry to consider similar efforts.” CM is generally considered to
be more efficient as it consistently delivers a higher quality product. And, as Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, noted: “A number of companies are on the verge of adopting advanced manufacturing techniques such as CM, which are not susceptible
GEA believes that CM systems will represent one of the most important paradigm shifts in pharmaceutical drug production
to many of the problems of traditional production models. CM can transpire in a single small room, starting with raw materials at one end and finishing with tablets on the other.” When she advised the pharmaceutical industry to get ready for the concept of continuous drug production, GEA was already there. Te company has long been working on flexible development options that facilitate the commercial manufacturing process and enable greater process understanding to be achieved with smaller quantities of material.
Impressive potential Potential API savings of more than 60% and time-to-market reduced by more than a year have been identified by companies using small-scale CM systems. And, it’s predicted that in 10 years, the vast majority of tablets will be produced on CM lines that are installed in modular
facilities that are a fraction of the size of current plants. FDA has said for several
years that if drug-makers paid more attention to high quality manufacturing, it would prevent the regulatory problems that lead to plant closures and costly fixes. “CM also allows manufacturers to respond much quicker to changes in demand, potentially contributing to the prevention of drug shortages,” Yu added. In fact, the agency recently designated an oral solid dosage form that has been developed and produced using GEA’s ConsiGma CM platform, as a breakthrough therapy. Te approval allows expedited development and review, effectively giving the company – a GEA customer – the green light to manufacture the drug using CM technology.
Te ConsiGma continuous tableting line is a multipurpose platform that has been designed to transfer powder into coated
tablets in development, pilot, clinical and production facilities in a single compact unit. Furthermore, the ConsiGma 25 unit forms the basis of an innovative collaboration between Pfizer, GSK and G-Con to develop the next generation of portable, continuous, miniature and modular (PCMM) solutions for pharma production. Tese on-demand mini-factories can be set up to manufacture medicines at any production scale, anywhere in the world where basic facilities are available. GEA believes that CM is fundamental to the future of the pharmaceutical industry and represents an exciting step forward in drug production.
For more information ✔ at
www.scientistlive.com/eurolab
Richard Steiner is with GEA.
www.gea.com
www.scientistlive.com
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