A report from bioLIVE 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.
Establishing a sustainable pipeline of qualified staff into the rapidly maturing biologics supply chain has been identified as a key issue. Data from the 2018 BioPlan Associates Annual Survey identified three key areas where small molecule expertise could see cross industry benefits—process control (33 percent), quality management (30 percent), and training operators and technicians (29 percent).
Emil Ciurczak, president of Doramaxx Consulting and pharmaceutical industry 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,” according to Ciurczak. For instance, he said 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 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, among others, into commercial production, Girish Malhotra contended 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,” Ciurczak said.
The report predicts that over the next few years the industry likely will see a “technological arms race” among outsourcing providers to help increase efficiencies, lower costs, and decrease clinical timelines in bio development and manufacturing. To take just one example, technologies that help reduce the cost of the expensive protein A capture step in biomanufacturing could potentially represent a huge process improvement, according to the report.
In terms of contract manufacturing, the report foresees cell and gene CDMOs growing quickly, albeit from a low base—especially as more products enter commercial stage. Another approach to differentiate and achieve growth for smaller bio CDMOs is novel technologies that speed production and lower costs.
Already big pharma has been partnering with a number of smaller biotechs for anything from AI technologies to 3D micro-organoid modeling and bio process improvements—the latter is where there will likely be a new “arms race” for the best technologies among outsourcing providers. Big pharma also will seek to mirror its approach in the small molecule industry, and mitigate supply chain risk, by seeking to partner with several CDMOs in both development and commercialization of its most profitable new targets, according to the report..
bioLIVE, a new biomanufacturing and bioprocessing event, takes place October 9 to 11 in Madrid.
(Source: bioLIVE; Photo credit: Denis Poroy, Associated Press)
Filed Under: Drug Discovery
