Matt Moran
Director, BioPharmaChem Ireland (BCPI)
A consortium of companies are working to drive digitisation and sustainability within the biopharma small molecule active pharmaceutical ingredients sector by adopting the principles of Factory 5.0.
Factory 5.0 takes the principles of Factory 4.0 and adds on sustainability and the need to ensure the needs of the employee are incorporated. It is important for the biopharma sector as it offers the opportunity for sites to become more competitive through digitisation of their operations and also facilitates the sites becoming more sustainable – key as we witness the finalisation of the COP26 negotiations.
A roadmap to support API sector
A consortium of companies led by J&J and supported by BPCI and IDA Ireland has been established to develop a roadmap to support an ecosystem to bring the small molecule active pharmaceutical ingredient (API) sector towards the principles that underpin Factory 5.0.
The cluster comprises a number of captive API companies including Janssen, Pfizer, MSD, Merck, Eli Lilly etc. a range of contract development and manufacturing organisations (CDMOs) including SK Biotek and Thermofisher as well as some technology companies including Analog devices and Siemens Healthcare.
Factory 5.0 takes the principles of Factory 4.0 and adds on sustainability and the need to ensure the needs of the employee are incorporated.
Creation of business opportunities
Each of the API companies in the cluster have been assessed by Irish SME Innopharma to gauge their level of maturity along the road to Factory 5.0. A portal for collaboration and new business opportunities has been built. The group will now strive to build an eco-system that can be rolled out to the rest of the industry including drug product and biotech manufacturers.
Each site will be at a different stage in the process so it is important to design a roadmap that the entire sector can follow and share expertise and knowledge. Innopharma have played a key role in conducting maturity assessment for a number of pilot sites.
Keeping Ireland’s manufacturing attractive
There is no doubt that as the projects unfold additional skills and talent development requirements will emerge. BPCI intend to roll out the project to drug product and biotech facilities in time. The support of Government through IDA Ireland and Enterprise Ireland is welcome and important. Given the supply chain challenges that the pandemic revealed resulting in shortages of some medicines, it is likely that the EU will look to reshore some manufacturing – a project like this can ensure that the sector in Ireland will be attractive for this.
