The concept of biomanufacturing - using bacterial or mammalian cells to produce complex and powerful biopharmaceutical products - is fantastic. For scientists it opens up the possibility of creating therapies for untreatable diseases by mimicking complex naturally occurring molecules and for drug industry executives it provides a way of filling pipelines with high-value, hard to copy blockbusters.
The trouble is that, compared with traditional small-molecule drugs, making biopharmaceuticals and biologics is a huge challenge, largely due to the variability inherent in a production system that is based on growth of living cells in a bioreactor.
The other major hurdle biomanufacturers face that the majority of their counterparts in the small molecule drug field do not is that regulators assess not only the biopharmaceutical product itself but the manufacturing process that is used to make.
Once approved, that’s it.
As a result, changing approved processes to incorporate technical innovations involves spending lots of money and expending considerable effort according to Prof J Chris Love from the Massachusetts Institute of Technology’s (MIT) Dept. of Chemical Engineering.
He told BioPharma-Reporter.com that: “Incorporating changes in an approved process for manufacturing a biologic can be challenging. Being aware of the best innovations during bioprocess development may help avoid delays or modifications later in production.”
Prof Love explained that while for monoclonal antibodies (MAb) the production process is streamlined and straightforward, “there are still challenges in selecting the best hosts and process conditions for other classes of biologics like enzymes.
“Better experimental models for process development that integrate all aspects of the process would also be helpful, especially with an increasing emphasis on continuous processing. Small-scale systems that leverage advances in microtechnologies are poised to begin addressing this need.”
Latest biopharma news
And this is where BioPharma-Reporter.com will help. We will report the latest technological breakthroughs in the biopharmaceutical sector. Whether it be a new high-yield cell line, disposable bioreactor or innovative downstream filtration system, our subscribers will hear about it here first.
We’ll scour the newswires, scan social media channels and seek out the latest developments in scientific journals to bring you the information you need. But let’s make this is a two way process.
If you have an innovation or new technology you think the biomanufacturing sector should know about tell us what it is - and most importantly - why it is of interest to the wider industry via our feedback form; twitter @BioPharmaReport; or email gareth.macdonald@wrbm.com.
We look forward to bringing you the latest biomanufacturing news.
The editorial team