06.29.18
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%), 'quality management' (30%), and 'training operators and technicians' (29%).
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," said Mr. Ciurczak. "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 U.S. FDA 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 argued that the small molecule industry's 50+ years of manufacturing pedigree can bring vital contributions. Examining the emergence of continuous bioprocessing, Mr. 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," said Mr. Ciurczak.
The report predicts that over the next few years we will likely 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.
In terms of contract manufacturing, the report foresees cell and gene CDMOs growing quickly, all be it 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 we have seen big pharma partnering with a number of smaller biotechs for anything from AI technologies to 3D micro-organoid modelling and bio process improvements-the latter is where there will likely be a new arms race for the best technologies amongst outsourcing providers. Big pharma will also 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.
"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," said Rutger Oudejans, brand director pharma at UBM. "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."
bioLIVE is the new UBM (part of Informa PLC) biomanufacturing and bioprocessing event taking place in Madrid October 9-11, 2018. For more information visit https://www.bio.live
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%), 'quality management' (30%), and 'training operators and technicians' (29%).
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," said Mr. Ciurczak. "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 U.S. FDA 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 argued that the small molecule industry's 50+ years of manufacturing pedigree can bring vital contributions. Examining the emergence of continuous bioprocessing, Mr. 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," said Mr. Ciurczak.
The report predicts that over the next few years we will likely 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.
In terms of contract manufacturing, the report foresees cell and gene CDMOs growing quickly, all be it 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 we have seen big pharma partnering with a number of smaller biotechs for anything from AI technologies to 3D micro-organoid modelling and bio process improvements-the latter is where there will likely be a new arms race for the best technologies amongst outsourcing providers. Big pharma will also 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.
"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," said Rutger Oudejans, brand director pharma at UBM. "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."
bioLIVE is the new UBM (part of Informa PLC) biomanufacturing and bioprocessing event taking place in Madrid October 9-11, 2018. For more information visit https://www.bio.live
