Building Analytical Strategies for Scalable Antibody Development

Strengthening IND-Stage mAb Programs: Analytical Areas That Shape Long-Term Success Building Analytical Strategies for Scalable Antibody Development IND submission is a critical milestone in mAb development — but it is not the end state. Analytical methods established during early development must ultimately withstand validation scrutiny, tech transfer, and increasing regulatory expectations. Decisions made during the IND-enabling phase can either support long-term scalability or create costly downstream rework. This webinar will explore three high-impact analytical areas that shape lifecycle success in IND-stage monoclonal antibody programs: molecular characterization, residual host cell DNA control, and microbial contamination risk. Through practical examples and “pressure-test” questions, we will examine how early titer strategies, impurity quantitation approaches, and microbial detection frameworks can be structured to evolve into validation-ready systems. Attendees will gain insight into common lifecycle gaps that surface during scale-up and regulatory review, and learn how to design analytical methods with durability, transferability, and regulatory robustness in mind. Early analytical choices in monoclonal antibody development can influence how programs progress through validation, technology transfer, and later-stage scale up and development. This webinar explores how decisions made during the investigational new drug (IND) stage can impact validation readiness, technology transfer, and regulatory success. Focusing on molecular characterization, residual DNA control, and microbial contamination risk, it highlights common gaps that can emerge as programs advance. Attendees will learn practical approaches on designing analytical strategies that are robust, adaptable, and fit for purpose across the different stages of development, helping reduce rework and support long term development success.