Applications of CE SDS gel in development of biopharmaceutical antibody‐based products

Abstract CE SDS gel technique offers many advantages over the traditional labor‐intensive SDS PAGE slab gel technology. The CE‐based method has increasingly been applied to many protein analysis applications. Specific examples are provided for monoclonal antibody (mAb), though the technique can be adapted to many other therapeutic protein products. Applications of CE SDS gel method using Beckman PA800 with UV detection are presented and discussed with respect to mAb analysis, such as purity, quantitation of non‐glycosylated heavy chain (NGHC) peak, identity, and stability. The stability of mAb is evaluated with respect to formulation buffer, accelerated temperature stress, UV light‐exposure, and high pH conditions. Both reducing and non‐reducing CE SDS gel conditions were applied and optimized to characterize mAb products. The data presented provides a “taste” of what CE SDS gel method can do to support the development of mAb products from early clone screening for product quality to the final product characterization. Since the CE SDS gel method is automatable, quantitative, robust, and allows for relatively high throughput, it provides both great analytical capacity and product coverage for a wide spectrum of protein product development in biopharmaceutical industry.