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Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.
A panel of experts have identified potential applications of small-molecule expertise that can be use in the biologics drug industry including continuous processing, API, and process analytical technology (PAT) expertise. The report also forecasts the increasing role outsourcing will play in the bio supply chain and the need to establish a sustainable pipeline of qualified manufacturing talent.
The report, Opposites Attract. Blurring the Lines between Small and Large Molecule Manufacturing, was released on June 27, 2018 by bioLIVE, a UBM biomanufacturing and bioprocessing event taking place in Madrid (October 9–11, 2018) in conjunction with the CPhI Worldwide trade show.
The report, which included 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%).
For example, Emil Ciurczak of Doramaxx Consulting, noted that Raman and 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.
The report predicts a ‘technological arms race’ over the next few years among outsourcing providers to help increase efficiencies, lower costs, and decrease clinical timelines in bio development and manufacturing.
The report also predicts fast growth for cell and gene contract development and manufacturing organizations (CDMOs) as more products enter commercial stage. Another growth factor for smaller CDMOs is novel technologies that speed production and lower costs such as artificial intelligence, 3D modeling, and bioprocess improvements.
“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 (part of Informa PLC), in a statement announcing the bioLIVE’s report.
“A key part of our value proposition with bioLIVE is to open the debate and increasingly foster collaborations between the two.”
Pharmaceutical Technology and CPhI/bioLIVE are brands of UBM (part of Informa PLC).