While the growth in Monoclonal Antibodies (mAbs) market has been incredible, challenges in downstream manufacturing persist. The typical mAb manufacturing process has several steps, including multiple clarification stages and one or more polishing columns. The steps if not properly designed impact yield, impurity and cost.
Downstream process development and manufacturing has become a strategic pivot for most companies to ensure the drug’s safety, quality, identity, purity, and efficacy (SQIPE) meet regulatory requirements for clinical trials and commercialization.
Successful replacement of reusable AEX columns by single use solutions has proven to be challenging, mainly due to scalability constraints and sensitivity of current technologies to subsets of the typical process conditions. 3M™ Polisher ST technology, which utilizes a guanidinium-functionalized polyamide membrane protected by a Q functionalized polypropylene material, has demonstrated the viability of replacing the depth filtration and anion exchange chromatography (AEX) steps to achieve a simplified and cost-effective process.