11.08.22 -- Molecular Biologic Formats Require Tailored CMC Solutions

Since bsAbs are highly engineered and often have complex structures, they can be prone to aggregation and problematic post-translational modifications, leading to low-titer, immunogenicity and immunotoxicity problems. This white paper explains how early developability assessment and analysis at early-stage development can help you select the best lead candidates and the optimum cell line.

This article details technologies for better assembly and expression and discusses how high throughput downstream, formulation and analytical solutions when combined with platform approaches and complemented by a toolbox of technologies for improving expression and cell line development, can accelerate the development timelines of multi-specific and bispecific antibodies.

While bi-specific antibodies (bsAbs) share structural similarities with monoclonal antibodies (mAbs), downstream purification faces challenges with bsAb-specific by-products such as mispaired chains, unwanted fragments, and higher aggregation levels. This article discusses the downstream issues that development scientists encounter and the need for rapid method development.

There is increasing demand for the development of manufacturing processes for bispecific antibodies in various molecular formats, which have more intricate product quality attributes. It’s critical the development of manufacturing processes is carried out with a design which allows resource efficiency, faster timeline to Tox/First-in-human (FIH) batch, and built-in flexibility.

New molecular formats and other recombinant proteins present facility- and product-specific development requirements that often render platform approaches inappropriate. Accordingly, addressing the most pressing challenges in process and analytical development associated with novel molecular biologic formats requires a keen understanding of the applicable tools and strategies.