Document 5DOzVOp9p22nZ6odKkxKRmV2N

Application Summary Table The table below highlights initial assessments of biopharmaceutical applications and likelihood that existing alternatives could replace the current application. The table does not represent an in depth through analysis and is not intended to represent a conservative worst-case analysis. It is intended to provide some assessment and industry perspective within the relative short consultation period. Please note that where alternatives may be available, there is often a high economic trade-off, risk of product loss, or incurrent revalidation time and cost. Application Liquid Filtration - Sterile Liquid Filtration - particulate Liquid Filtration - Virus Gas filtration Gaskets & Seals Components, Fittings, Tubing, Mixers, etc Pharmaceutical cryostorage Bags Cell culture cryostorage bags for cell therapy applications Non-Fluid Contact Materials (tubing clamps) Oleophobic/hydrophobic vent membranes PFAS Material Potential Alternatives Feasibility/Likelihood of Replacement* PVDF PTFE PVDF PTFE PVDF PVDF PTFE PVDF PTFE PVDF, FEP, PTFE PTFE, FEP, Custom Fluoropolymer FEP PVDF PES membranes, Nylon Membranes "" PES, Nylon PES, Nylon PES TBD TBD, PE TBD TBD PES, PP, Silicone, TPE ULDPE bags, EVA EVA or EVA blends Nylon, PP <50% <10% 75% 30% 80% <10% <10% 50% <20% 90% <50% 75% (with significant trade-offs) High PFAS-coated PES (Must redevelop) >90% with redevelopment Replacement cost/Process development/ Revalidation Very High Very High Moderate Moderate/High Very, Very High Moderate High Moderate Moderate High High Very High Low High Typical Replacement where available Timeline (yrs.)** 9+ per case Patient Safety /Drug Quality Impact Risk High Market Fraction / Impact Very High 9+ per case 5+ per case 5+ per case 8+ per case 4+ per case 7+ per case TBD TBD 3+ per case TBD 10+ per case <1 11+ per case High Moderate Moderate Moderate Moderate Moderate High High Moderate High High Low High Low High Low Moderate Very, Very High Moderate Moderate Moderate High Growing Growing Moderate High Table 1. Non-exhaustive overview of common bioprocess materials, including likelihood of identifying alternatives for each drug manufacturing use, estimated replacement resource cost and timelines when suitable alternatives are available, the risk to drug product quality and patients, and overall prevalence of use in the bioprocess market. For additional applications, please see text. *Feasibility/Likelihood of Replacement represents best estimates of the number of drug manufacturing use cases where a suitable alternative may exist and replaced with an alternative. **Typical Replacement Timeline represents the estimated time per drug application use case, when testing and qualification resources are available. 1 Bio-Process Systems Alliance 1400 Crystal Drive, Suite 630 Arlington Virginia USA www.bpsalliance.org