Specialty Medicines and Facilities of the Future are the new challenges–The biggest pharmaceutical products are now specialty medicines. Not 'biggest' from a volume perspective, but from a value perspective. This has significant implications for manufacturing, especially on flexibility needs.
Specialty medicines add a new challenge for pharmaceutical manufacturing because there is a trend towards focusing on disease areas rather than just product segments. You see it in almost all the big pharma companies and many of the small and mid-sized companies have had it for many years.
But as we see the shift towards smaller and more specialized medicines, there is a much closer link between the pharma company and its target patient group. This link is even more visible when we talk about small diseases or even orphan diseases. The pharma companies tend to work closer with their patients and adapt their products to serve their patients in the best possible way, which often means that the need for manufacturing flexibility increases.
Targets become more specific
Furthermore, for years to come we must expect the target diseases to become more specific and possibly also patient groups to become more specific, implying that the demand for manufacturing flexibility is not going away any time soon but will be something we have to live with. Not just within the manufacture of drug substance and drug products, but also involving drug delivery systems, combinational drugs – just to mention a few.
Facilities built for flexibility?
Most of today’s pharma manufacturing facilities are not built for this type of flexibility and for many of them it also does not make sense to re-build them, because technology is becoming cheaper and new equipment that meets this demand for flexibility is only in an early beginning. We are starting to see a new generation of pharmaceutical technologies hitting the market that supports this requirement.
Single use biotech solutions are one of them. This whole area has matured over the last 10 years into a number of very flexible solutions that can be adapted for both upstream and downstream drug substance manufacturing and also into some of the manufacturing steps of drug products, especially within aseptic processing.
Stainless steel solutions still have a future, but the new pharma reality requires careful decisions on where to use what. Finding the right balance is a challenge but it is necessary to ensure the needed flexibility for the “Facilities of the Future”.
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