Biological medicines already account for around 10–15% of the current pharmaceutical market and the sector is outperforming the industry as a whole. More than one-fifth of new medicines launched on the world market each year are now biotechnology-derived. According to the latest report from Pharmaceutical Research and Manufacturers of America (PhRMA),1 in the US alone some 452 new medicines for rare diseases, including genetic disorders, neurological conditions, infectious diseases and autoimmune disorders, are being developed by biopharmaceutical companies.
With Big Pharma desperate to fuel its dwindling pipelines, it is looking to be part of this rapidly growing market, but the switch from traditional chemical synthesis-based small molecules to the new biologically-based therapies (biosimilars, mAbs, ADCs, vaccines, gene therapy, recombinent therapeutic proteins, regenerative therapies) requires huge investment in new biotech production facilities.
The production of such novel biologicals is not without challenges. At the recent UK Bioscience Forum, organised by the UK’s BioIndustry Association (BIA) in London, Stephen Ward, COO of the UK’s government-funded Cell Therapy Catapult, outlined some of the major issues that the biotech industry faces in its transition from R&D to commercial products: problems of scale, product characterisation, product release and shelf life, variation of raw materials, and logistics.2
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