In the race to bring a new biotherapeutic to market, unexpected obstacles can slow you down or even knock you back a few steps. But with the right information at the right time, and an experienced partner to provide scientific, regulatory, and bioprocessing guidance and support, you can find a smoother, faster path to the finish line.

A discussion on how novel treatment modalities such as viral vectors and the urgent need for SARS-CoV-2 treatments and vaccines are driving the advance of biopharma. 

Small differences in manufacturing conditions can have dramatic effects on a product’s structure and biological activity. Characterization is essential to understand the impact following process changes and successful biosimilar development. We will provide best approaches for comparability studies.

The pressure to shorten delivery times and reduce costs for biologics such as mAbs are driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. In this talk we will explore how new methods can be used to accelerate biosafety testing today.

Is viral clearance a hurdle to implementing continuous processing? We’ll share virus spiking alternatives that may pave the way for effectively evaluating viral clearance by chromatography steps in a continuous process.

Small changes to the design of antibody-drug conjugate can have a dramatic effect on its structure and biological activity. Here we discuss methods to provide insight at critical junctures in ADC development.

Learn product characterization strategies to de-risk manufacturing and detect and characterize host cell proteins and polyethylenimine in mAb and cell and gene therapies .

MilliporeSigma Senior Scientist Agata Burzawa, MSc, explains how we can provide you with rich data sets to help you understand your complex biotherapy faster. Using limited volumes of samples for testing, our scientists employ leading technologies that integrate cytokine release monitoring with immunophenotyping of cells within the same sample.

MilliporeSigma Senior Scientist Helen Hsu, Ph.D. describes how, with our custom binding assays, and supported with our comprehensive off-the-shelf Fc gamma receptor binding assays, we can help you optimize your mAb production, from clone development through upstream and downstream processes.

Newer, high-resolution analytical techniques help answer questions regarding product heterogeneity and drug functions, and help assess for product-related aggregates and impurities.

In this webinar, multiple approaches to characterizing the physico-chemical and structural attributes of therapeutic mAbs is presented with a focus on how it influences the resulting biological activity.

Gain an understanding of how an antibody’s molecular structure and its many measurable properties influences its binding and affects potency of a therapeutic biologic.