The use of pre-packed chromatography column technology for purification of biologics and vaccines has become more widespread in the past several years. Multiple commercial vendors provide pre-packed, “single-use” columns in a variety of different resin chemistries and in column sizes up to 60 cm in diameter. The advantages of pre-packed columns include increasing operational flexibility, making rapid changeovers between products feasible, eliminating the need for column cleaning, sanitization and packing, and minimizing in-house validation and documentation requirements. The current work presented here explores the potential utility of pre-packed chromatography columns in a Biological Pilot Plant setting for use in purification of therapeutic monoclonal antibody (Mab) and vaccine candidates. The advantages and disadvantages of pre-packed column technology are presented relative to conventional packed columns. Factors including cost and processing times are evaluated for columns from different manufacturers using Mab purification as the comparator. Pre-packed columns present an advantage when a challenging new media (resin) or condition (sterility) is required within the fast moving clinical space. For instance, chromatography used for live-virus vaccine (LVV) purification presents a unique challenge due to the need for sterile operation. The impact of autoclave and gamma sterilization processes on resin functionality will be examined.<br/>

Evaluation of large scale disposable pre-packed columns for use in biologics and vaccine purifications

251st National Meeting (2016)

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