By a News Reporter-Staff News Editor at Drug Week -- Research findings on Immunology are discussed in a new report. According to news reporting out of Hopewell, New Jersey, by NewsRx editors, research stated, "Cleaning-in-place (CIP) for column chromatography plays an important role in therapeutic protein production. A robust and efficient CIP procedure ensures product quality, improves column life time and reduces the cost of the purification processes, particularly for those using expensive affinity resins, such as MabSelect protein A resin."
Our news journalists obtained a quote from the research from Bristol-Myers Squibb, "Cleaning efficiency, resin compatibility, and facility compatibility are the three major aspects to consider in CIP process design. Cleaning MabSelect resin with 50 mM sodium hydroxide (NaOH) along with 1 M sodium chloride is one of the most popular cleaning procedures used in biopharmaceutical industries. However, high concentration sodium chloride is a leading cause of corrosion in the stainless steel containers used in large scale manufacture. Corroded containers may potentially introduce metal contaminants into purified drug products. Therefore, it is challenging to apply this cleaning procedure into commercial manufacturing due to facility compatibility and drug safety concerns. This paper reports a safe, effective and environmental and facility-friendly cleaning procedure that is suitable for large scale affinity chromatography. An alternative salt (sodium sulfate) is used to prevent the stainless steel corrosion caused by sodium chloride. Sodium hydroxide and salt concentrations were optimized using a high throughput screening approach to achieve the best combination of facility compatibility, cleaning efficiency and resin stability. Additionally, benzyl alcohol is applied to achieve more effective microbial control. Based on the findings, the recommended optimum cleaning strategy is cleaning MabSelect resin with 25 mM NaOH, 0.25 M Na2SO4 and 1% benzyl alcohol solution every cycle, followed by a more stringent cleaning using 50 mM NaOH with 0.25 M Na2SO4 and 1% benzyl alcohol at the end of each manufacturing campaign."
According to the news editors, the research concluded: "A resin life cycle study using the MabSelect affinity resin demonstrates that the new cleaning strategy prolongs resin life time and consistently delivers high purity drug products."
For more information on this research see: A safe, effective, and facility compatible cleaning in place procedure for affinity resin in large-scale monoclonal antibody purification. Journal of Chromatography A, 2013;1308():86-95. Journal of Chromatography A can be contacted at: Elsevier Science Bv, PO Box 211, 1000 Ae Amsterdam, Netherlands. (Elsevier - www.elsevier.com; Journal of Chromatography A - www.elsevier.com/wps/product/cws_home/502688)
Our news journalists report that additional information may be obtained by contacting L. Wang, Bristol Myers Squibb Co, Proc Sci, Hopewell, NJ, United States. Additional authors for this research include J. Dembecki, N.E. Jaffe, B.W. O'Mara, H. Cai, C.N. Sparks, J. Zhang, S.G. Laino, R.J. Russell and M. Wang (see also Immunology).
Keywords for this news article include: Antibodies, Drugs, Anions, Therapy, Hopewell, Chemicals, Chemistry, New Jersey, Immunology, Hydrocarbons, United States, Blood Proteins, Topical Agents, Benzyl Alcohols, Immunoglobulins, Sodium Chloride, Benzyl Compounds, Sodium Compounds, Sodium Hydroxide, Hydrochloric Acid, Respiratory Agents, Benzene Derivatives
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