Bioprocessing overlap: Taking lessons from small molecule makers
The preliminary data from the 15th Annual Survey on Biopharmaceutical Manufacturing Production and Capacity – released to Biopharma-Reporter ahead of its publication in May – shows biomanufacturers are looking to learn from their counterparts in the small molecule industry.
The data was independently compiled by life science market research firm BioPlan Associates, but is being used by bioLIVE, a biomanufacturing event launching at CPhI Worldwide later this year which intends to help bring the small and large molecule industries together.
A question posed to 120 bioprocessing professionals regarding the intersection of large biopharma and any benefits it could derive from small pharma manufacturing found approximately a third placed 'process control, real timep as an area for learning opportunity.
Crossover with quality management and training operators and technicians were second and third in the poll - 30% and 29.2% of respondents respectively - though at least one in five of the biomanufacturers believe there are also lessons to be learned in the following areas: Clean room operations, scale-up or process development, regulatory compliance, automation process control, continuous processing adoption, general R&D and general cGMP manufacturing.
According to commentary from BioPlan Associates, bioprocessing is transforming from an industry in its infancy to one that can generate its own optimisation data and techniques.
And as biologics processing matures, it can take lessons from small molecule operations to help produce more product, at better quality, and at lower cost.
“In the past, biologics manufacturing had to be done at most any cost, simply to get a product to the clinic. In comparison to small molecule drug production, which has had many decades, if not centuries to improve its production efficiency, biologics are relative newcomers to modern production technology, automation, monitoring and optimization.”
Hiring expertise
The survey also asked where respondents have hired personnel specifically for their small molecule expertise, with preliminary data showing scale-up and process development, and engineering and facility design roles heading the areas where staff and consultants have been placed.
One of the findings from the 14th Annual Report and Survey of Biopharmaceutical Manufacturing was the shortage in bioprocessing expertise, creating bottlenecks in the biomanufacturing space.
And while there are a number of training options in the bioprocessing sector emerging from government, academia and industry – NIBRT in Ireland, the North Carolina State University’s Biomanufacturing Training and Education Center (BTEC) and the Biotech Training Facility in Leiden, The Netherlands, etc – the process is slow.
