Building Quality By Design For Multi-Specific Therapeutic Proteins

Multi-specific biotherapeutics, which can bind to two or more targets, are becoming increasingly important for treating complex diseases. They offer enhanced efficacy and broader treatment options compared to traditional single-target therapies. While many multi-specific molecules are advancing into clinical trials, their manufacturing process is more complex and presents unique challenges. These challenges arise in both the early and late stages of manufacturing, making it harder to achieve the desired product profile.

For simpler molecules like monoclonal antibodies (mAbs), manufacturing is relatively low-risk and can be accelerated due to the industry's extensive experience with them. However, with multi-specific molecules, this risk increases, especially when trying to speed up early drug development. It's crucial to consider manufacturability and immunosafety early on, during the discovery phase. By incorporating this feedback into the molecular design, potential risks can be mitigated before the final sequence is chosen.

To address these challenges, companies like Lonza are using platform technologies. Their toolbox approach incorporates high-throughput in silico screening, vector design, and human immune cell assays. This system allows for early screening of a molecule's potential titer, assembly, potency, and immunosafety. This early data is vital for selecting the best candidates and accelerating their progress into clinical development.