27 June 2018, Amsterdam: A report from bioLIVE – the new UBM biomanufacturing and bioprocessing event taking place in Madrid (October 9-11, 2018) – has collected findings from a panel of experts to identify a number of potential applications of small molecule expertise that should be applied to the biologics industry. The report forecasts the increasing role outsourcing will play in the bio supply chain and how continuous processing, API and process analytical technology (PAT) expertise will be integral to future growth.
Emil Ciurczak of Doramaxx Consulting, a CPhI Annual Report expert, argues this is only the tip of the iceberg, and that if the question were to be reversed – i.e. asking small molecule experts about the areas where their technology could be of use to the large molecule industry – that the positive responses would be much higher. ‘Although the positive response data from biopharmaceutical manufacturers may not appear that high, this could be due to a lack of familiarity with the level of expertise of technology available to them, rather than a firm understanding of the sector and a discounting of its relevance.’ For instance, Raman and NIRS (near-infrared spectroscopy) could be used for the testing of incoming raw materials, checking clinical supplies, and – comparing fermentation to API synthesis – monitoring a reaction (even if final release is by compendial methods).
He also identified the implementation of PAT as a key area for greater collaboration, adding that ‘indeed, the USFDA plainly stated that the Guidances and ICH Q8, 9, and 10 were designed for small molecules. Consequently, a “pure” biologics company will not have direct experience with PAT and there is a time gap in familiarity’. But he warned that ‘the bio industry needs to do more to attract talent, as seldom do small molecule personnel switch careers to work in Biopharma companies’.
With the industry still debating on how best to bring CAR-T therapies, amongst others, into commercial production, Girish Malhotra argued that the small molecule industry’s 50+ years of manufacturing pedigree can bring vital contributions. Examining the emergence of continuous bioprocessing, Malhotra said ‘(bio) manufacturers will need experienced fermentation masters, chemists and chemical engineers who understand finances, process development and process simplification values.’
Another surprising area for cross-industry collaboration is between API experts and bio, as the instruments used for chemical and physical measurements for API production may only need minor alterations to be useful in fermentations. ‘Continuous chromatography, which is beginning to become more common in API work, could also be used in bioprocesses.’ concluded Ciurczak.
The report predicts that over the next few years we will likely see a ‘technological arms race’ amongst outsourcing providers to help increase efficiencies, lower costs and decrease clinical timelines in bio development and manufacturing.
