Biotech Manufacturing Software – There’s a shift in the wind!
I’ve been working the last nine years for a software integration firm, named for Apps Associates. We are headquartered outside of Boston in the Biotech Startup hot spot. Since Cloud Software as a Service solutions first became available around 2015, we have been standing up Oracle Cloud based manufacturing solutions for a boat load of Biotech start-ups. We’ve seen it really start to take off. For the first few years, it was always the same model – stand up Financials first, then an outsourced Supply Chain solution that focused on Demand / Supply Planning and integration with external contract manufacturers (CMO’s). These early stage companies did not have the funding or expertise to do scaled up manufacturing. So they outsourced it. Oracle had a great CMO Supply Chain solution with an extensive integration model for easy collaboration with CMOs and suppliers. For these clients, it was all about the supply chain visibility and coordination. That’s all they needed.
Enter Precision Medicine: The CRISPR cell / gene editing technique was discovered in 2012 by Emmanuelle Charpentier and Jennifer Doudna. They recently won the Nobel Prize for Chemistry for this breakthrough scientific achievement. This technique allows scientists to find and replace specific disease causing genes or cells in the human body. These companies also engage in a lot of diagnostics to understand which genes are causing the disease in the first place. Once they have the solution figured out, there is a lot of complex, advanced manufacturing to grow, filter, and amplify the cell editing medications. I‘m not a scientist and I am probably oversimplifying this, but a couple of things I have gathered are:
- Cell editing companies are extremely concerned about the confidentiality of their manufacturing processes. It is a repeatable playbook here. You have probably seen some of this in the press with vaccine companies stating they can easily adapt the vaccine to new virus variants. So they want to re-use their processes against different targets / diseases. They don’t necessarily want other companies to know how they do it.
- It’s an extremely quality sensitive process that involves advanced scientific knowledge and equipment. Companies are concerned that any outsourced manufacturer has to have the advanced scientists, equipment and Quality Control processes to make the medication. CMOs don’t all have this. So they don’t necessarily always trust outsourced CMOs to manufacture for them. Sometimes they will partner up with a Big Pharma company to develop and manufacture, but that can cost them future profits.
Precision Medicine Biotech companies have exploded over the last few years with there now being over 1,000 companies in this space globally. In addition, Biotech drugs are occupying over 70% of late stage clinical trials pipeline. The new ERP software model for these companies places a high priority on internal manufacturing software – especially what’s known as “Process Manufacturing” and “Quality”.
All in all, it’s still a mixed bag, with some companies wanting to partner up with CMOs or Big Pharma for external manufacturing and others preferring to manufacture internally.
Fortunately for us (and our clients), we are an Oracle systems implementation partner. The Oracle ERP Cloud solution has continuously evolved to include all of these Biotech features and capabilities. Oracle ERP Cloud has the ability to make “batches” of medicines or intermediates with recipes, variable inputs and yields, multiple units of measure, lot numbering, expiration dating and traceability. It also includes a robust Quality module for integrated manufacturing inspections, process monitoring and non-conformance tracking. The nice thing is you don’t have to choose between an internal and an external manufacturing model. Oracle ERP Cloud allows you to mix and match functionality as desired to manage internal manufacturing as well as supplier / CMO based external manufacturing.
So whatever the need, bring it on! We are ready to take Biotech manufacturing systems to the next level! If you’d like to talk more about this, drop me a line at [email protected]