Repligen™ OPUS (open Platform User Specified) prepacked columns packed with CaptivA™ PriMab™ Protein A resin offer high performance and all the advantages of single-use technology (reduced validation effort, reduced risk, faster time-to market). What makes this solution truly unique, however, is that oPUS prepacked columns provide lower total cost of ownership in many applications compared with conventional stainless steel or glass columns.

Single-Use Chromatography Study

BioPharm Services ltd (Chesham, UK) conducted a study to assess the impact on total cost of ownership of using low-cost, high-performance Protein a resin in prepacked, disposable columns. the conclusions reveal that for applications in which the bioreactor is 1,000 L or smaller and the number of batches does not exceed 20, the use of oPUS columns prepacked with Captiva PriMab resin can result in savings up to 15% as compared with conventional columns packed with more commonly used resins.

Figure 1 compares the cost of goods per gram for a 500-L bioreactor, single chromatography run. the CaptivA prepacked column provides fairly significant savings when compared with other Protein A resins packed in conventional columns. Figure 2 shows the same cost breakdown for a larger 1,000-l, 20-batch process. in this scenario, the costs of using disposable CaptivA chromatography are comparable to traditional methods; however, users of the single-use technology enjoy the well known benefits of disposable equipment including

• Reduced validation

• Reduced risk

• Faster time-to-market.

Figure 1: ()

Figure 2: ()

Common applications likely to fit the operating profile for prepacked OPUS columns with CaptivA PriMab Protein A resin include

• Preclinical

• Early stage clinical

• Small-scale and/or periodic commercial manufacturing

Also, end-user multiuse facilities or contract manufacturers that process multiple products in a single facility can clearly benefit from using disposable chromatography solutions.

Conclusion

Due to high resin costs, manufacturers have been unwilling to adopt disposable affinity chromatography in downstream MAb processing despite the obvious advantages of single-use solutions. repligen’s CaptivA PriMab Protein A resin is a low-cost, high performance resin that, when prepacked in OPUS columns, offers cost savings when compared to conventional technology while still providing faster time-to-market and reduced processing risk.

Author Details
Steven Tingley is Vice President Bioprocessing, Repligen Corporation, 41 Seyon Street, Waltham, MA 02453; 1-781-250-0111, stingley@repligen.com; www.repligen.com.