At April’s BPI European Summit in Amsterdam, Jean-Marc Cappia from Sartorius Stedim Biotech (SSB) addressed end-user concerns on the quality and assurance of its vendor-supplied single-use equipment by stressing the importance of his own company’s supply chain.
“Single-use system suppliers must better characterise raw materials and control their manufacturing process to improve assurance of supply, quality, change control and business continuity,” Cappia, VP of Marketing & Product Management at SSB, told delegates.
Without this, end-users risk supply shortages as well as quality issues through extractables and leachables (E&L) stemming from poorly characterised disposable films and plastic systems, he continued, adding established partnerships with a vendor’s own suppliers is key.
“[Vendors] have some struggle to get access to the resins from suppliers,” he said. “The business for resins in the bioprocessing industry is very small – just a few tonnes per year compared to maybe millions of tonnes in the car or food industries.”
Thus SSB had to educate its resin suppliers about the regulatory requirements and end-user challenges in the biopharma space, teaching them about the importance of notifying SSB when they make a change, for example.
Cappia also spoke of the dilemma faced by vendors surrounding material characterisation. “You want to have the best quality film, but there is also a need for assurance of supply.”
SSB itself applies quality-by-design (QbD) and process controls to characterise the compatibility of its resins with biological substances, but Cappias said avoiding any risk of material shortage and guaranteeing long-term supply are just as important.
“If you go for a very specific resin then you may struggle with assurance of supply. For us the key was to use blockbuster resins and from these resins make the best formulation that meets our requirements.”
This has left SSB in the position where it can ensure four years of unchanged resin supply for production of its film and bags, he added.
Having end-to-end control of the manufacturing process is also a key factor for single-use vendors.
According to Cappia, material specifications and process controls established at all stages of the supply chain and manufacturing process can reduce material and process variability while improving quality, change control and business continuity.
For SSB, the resin and film is produced through partnerships and contracts with third-parties while the bag, component and assembly is done in-house. The products are then sterilised through contractors.