Mohamed Noor PhD
Digitalization Manager, NIBRT
With digitalisation being the next frontier in biotechnology, having access to a skilled workforce will be as critical as having the right infrastructure.
The COVID-19 pandemic has demonstrated that a combined regulatory and industry cooperation can pave the way towards rapid developments in the face of crisis.
Existing manufacturing facilities were rapidly repurposed and additional workforce were hired to meet the demand for COVID-19 vaccine manufacturing, while still meeting patients’ medical requirements for other diseases. At the same time, COVID-19 shows that biopharmaceutical manufacturing can be improved, new modalities should continue to be explored and the learnings from other industries will need to be tapped into.
Digitalisation is becoming mainstream
In parallel to the emergence of new therapeutics, advances in manufacturing have been made elsewhere across different industries. Digitalised revolution in manufacturing, collectively termed Industry 4.0 and 5.0, continues to provide leaner and sustainable processes, especially for globally distributed manufacturers.
Data analytics is quickly moving from being in the realm of machine learning specialists to being embedded in mainstream graphical tools. In the near-term, continued innovation in the digital space will be even more critical for cell and gene therapies where quick and error-free turnaround will be required from sample collection and infusion back into the patient.
Digitalisation encompasses much more than just replacing paper documents with their electronic counterparts.
Investing now for the future
Often, a major obstacle in the path towards digitalisation in biotechnology is the perceived difficulties in implementing compliant and holistic computer systems that span from enterprise resource planning to granular system control.
With biologic development costing an average of USD 1 billion per molecule, every one-day delay represents increased production cost and competition risk as well as a deferred availability for patients. A streamlined, digitalised clinical manufacturing process will assist the associated trials and regulatory filings. Hence, the upfront expenditure needed for digitalisation should be viewed as an investment within an organisation’s pipeline.
Equally critical is having a skilled workforce with a diversity in their talents and thinking. It requires an agile process with talents that are well familiar with the subtleties of bioprocessing while adhering to regulatory best practices.
Importantly, digitalisation encompasses much more than just replacing paper documents with their electronic counterparts. It requires a mindset change towards data-driven decision-making. In this regard, NIBRT continues to develop new programmes to meet industry needs by partnering with our clients and vendors. These programmes will capture the breadth of digitalisation across process development, manufacturing, and supply chain. In the longer term, our initiatives will ensure Ireland remains the location of choice for the biopharmaceutical industry.