Strategies for Fab purification and formulation

Monoclonal antibodies (mAbs) continue to be an important class of therapeutics for the biotechnology industry. In recent years, however, increased attention has been devoted to the development of "next generation" biologic therapeutics and manufacturing platforms. This shift is being driven by several factors including the need to develop more efficient and cost effective processes, reduce side effects and increase specificity to enhance efficacy.

Fragment antigen-binding (Fab) fragments can be produced using more economical expression systems (e.g. microbial), while retaining the target specificity of a mAb. Other advantages include elimination of non-specific binding between the Fc portions of antibodies and the Fc receptor on cells, and the ability to engineer the Fab region for improved specificity and therapeutic efficiency.

Antibody fragments are commonly produced as intracellular products in microbial expression systems such as E. coli. Following fermentation, cell harvest, and disruption, the downstream purification process typically consists of clarification, capture chromatography, polishing chromatography, and ultrafiltration/ diafiltration. Final formulation and sterile filtration take place prior to the fill finish.

Click the button below to read the article where we outline some of the unique requirements and challenges posed by antibody fragments in terms of recovery, purification and formulation.

For more information, please click here

In This Same Issue

• Chromabolt® prepacked columns with new resins increase productivity
• Demystifying bioreactor contamination risks