Ultrafiltration (UF) membranes in cassettes operating in Tangential Flow Filtration (TFF) mode are the biopharmaceutical industry standard for the concentration and diafiltration (UF/DF) of mAbs, vaccines, peptides, and other therapeutic proteins. <br/>Regenerated Cellulose (RC) composite ultrafiltration membranes such as Ultracel® (MilliporeSigma) are class leading UF membranes that combine ultra-low protein binding, low fouling, and organic solvent resistance with superb mechanical strength.  Ultracel® is available in Pellicon® 2 & 3 flat sheet TFF cassettes in various molecular weight cut-offs (NMWCO) for target molecule UF/DF processes.  UF/DF operations using cassettes in TFF mode offer high retention, efficiency, flexibility, linear scalability, and cost-effective reuse over several batch operations.  Typical end use of cassettes involves a series of steps including flush-out, rinsing, cleaning, sanitization, rinsing, and equilibration before use.  In order to be reused, cassettes must be cleaned and filled with a storage solution to ensure the membrane remains wet and to prevent microbiological growth without damage to the filter until next use.  Devices can then be flushed, cleaned, and sanitized prior to next use.  Some current recommended storage solutions include 0.1 N NaOH, 0.1% Lysol, or 1600-2400 ppm Benzalkonium chloride (BAK), but only guarantee 1 year stability and may present flushing challenges.<br/>This work will present a new long-term low pH buffer storage solution for RC membrane cassettes.  Data will show that it provides 3-year membrane and cassette stability, bioburden effectiveness, and low and benign solute flush-out.  Membrane and cassette stability are demonstrated through no significant changes in flux, dextran sieving, protein retention, and device integrity.  Bioburden effectiveness was demonstrated through meeting USP &lt;51&gt; category 1 criteria for antimicrobial effectiveness.  Finally, flush-out data will show the low levels of the common acid and base buffer components used in this benign and effective long-term RC cassette storage solution.<br/><br/>

Long-term storage solution offering membrane stability and bioburden effectiveness for regenerated cellulose ultrafiltration membrane cassettes

253rd National Meeting (2017)

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