LONG READHarmonizing the industry and improving confidence through risk-based microbial testingThe integrity of...
Bringing the needs of biopharmaceutical manufacturers and their suppliers closer
As a supplier, it can be hard to predict trends and anticipate the future needs of pharmaceutical manufacturers. With potentially long lead times from concept to supply, suppliers are often forced to invest in their ‘best guess’ and hope that they backed the right horse.
A Holistic Approach: Bridging the Gap Between Suppliers and Biomanufacturers, illustrates how BioPhorum’s Fill Finish (FF) workstreams have worked to help suppliers by describing specific details on what industry wants and expects from future technologies.
Published in a special supplement at BioProcess International, the article describes two case studies where FF workstreams have generated detailed User Requirement Specification (URS) documents to facilitate discussion and development with suppliers. Most recently, the container closure integrity (CCI) workstream published their URS on the future of testing technologies for CCI. A detailed roadmapping process initially pointed to a long-term approach focussed on disruptive technologies. Ongoing discussions, however, led to a shift in focus towards the shorter-term need for incremental improvements to current technologies. This has opened the door for the team to engage with a broad range of suppliers in open dialogue about the future of testing technologies for CCI, developing ongoing conversations that will continue into 2022.
The aim of any URS is to see its requirements realized in a form that can be purchased and implemented, and that is what is detailed in the case study built on the URS from the small flexible filler (SFF) team, first published in 2018. Shortly after publication, German isolator manufacturer Gröninger compared its own view of industry trends with those laid out in the URS and set out to meet the challenges the SFF team highlighted. Two and a half years later and Gröninger has its next-generation isolator commercially available, meeting virtually all the URS’ key deliverables.
The case studies demonstrate very effectively how aligning industry positions and sharing these openly with suppliers can serve both parties, leading to true win-win outcomes.
Understanding the industry baseline for electronic data exchange implementation across the inbound supply chain
LONG READReflections on Covid-19 inbound supply chain issuesCovid-19 has had a significant impact throughout the...