A report from bioLIVE — the new UBM biomanufacturing and bioprocessing event — has forecasted that outsourcing will play an increasing role in the bio supply chain and that continuous manufacturing, API and process analytical technology (PAT) expertise will be vital to future growth.
Report
The report, which includes a collection of findings from a panel of experts, identified that the establishment of a sustainable pipeline of qualified staff into the rapidly maturing biologics supply chain is a key issue for the sector. Data from the 2018 BioPlan Associates Annual Survey identified three key areas where small molecule expertise could see cross industry benefits — ‘process control’ (33%), ‘quality management’ (30%) and ‘training operators and technicians’ (29%).
However, this is only the tip of the iceberg according to Emil Ciurczak of Doramaxx Consulting, a CPhI Annual Report expert, who believes that if the question was asked to small molecule experts about the areas where technology could be of use to the large molecule industry there would be a higher number of positive responses.
“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,” he said.
Additionally, he identified the implementation of PAT as a key area for greater collaboration. “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,” he explained.
However, Ciurczak also warned that more needs to be done by the industry to attract talent, ‘as seldom do small molecule personnel switch careers to work in Biopharma companies’.
Looking at how best to bring CAR-T therapies, as well as others, to commercial production, Girish Malhotra revealed that the small molecule industry could offer some helpful expertise and experience. With the emergence of continuous bioprocessing there will be a need for ‘experienced fermentation masters, chemists and chemical engineers who understand finances, process development and process simplification values’.
Ciurczak highlighted another way that there could be cross-industry collaboration between API experts and bio — 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,” he concluded.
Furthermore, the report predicted that there will likely be a ‘technological arms race’ between outsourcing providers to help increase efficiencies, lower costs and decrease clinical timelines in bio development and manufacturing.
For contract manufacturing, the report revealed that there should be rapid growth in cell and gene CDMOs, particularly as more products enter commercial stage. Novel technologies that will speed up production and lower costs will be another way for smaller bio CDMOs to achieve growth and differentiate themselves in the market. Examples include partnerships between big pharma and smaller biotechs for AI technologies, 3D organoid modelling and bio process improvements. This latter area is highlighted as the most likely that will see a new ‘arms race’ for best technologies among outsourcing providers.
There is also expected to be a mirroring by big pharma in the small molecule space with a mitigation of supply chain risk. They will do this by partnering with several CDMOs in both development and commercialisation of its most profitable new targets.
Rutger Oudejans, brand director Pharma at UBM (part of Informa PLC), commenting on bioLIVE’s first industry whitepaper, added: “We are only just now beginning to see the potential of a cross industry collaboration between these two formerly distinct industries. And our experts are only just starting to explore the ways in which these two industries could collaborate to improve production timelines, efficiencies and regulatory compliance. Already there is a consensus that API technology could be applicable and that bio companies should encourage more small molecule experts into the industry as it grows. Particularly, those with PAT and process development expertise. That is without even considering how the two pipelines are becoming increasingly blurred with peptides and ADCs. A key part of our value proposition with bioLIVE is to open the debate and increasingly foster collaborations between the two. With our co-located events, CPhI and ICSE — API & contract services respectively — the complete supply chain will be able to meet new partners. This will prove essential to a quickly maturing bio supply chain, and will be key to future development.”