ABOUT MILLIPORESIGMA

Choosing the right partner for analytical and bioanalytical services is critical in the approval race. MilliporeSigma’s BioReliance® Testing Services offer exceptional, risk-mitigating solutions to help you bring life-changing drugs to market, faster. Our testing and manufacturing services span the product cycle from early pre-clinical development to licensed production. Partner with us to meet your needs for Biologics Safety Testing, Product Characterization and Biomanufacturing Services. See our full suite of capabilities.

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The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the US and Canada

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VIDEOS

ICH Q5A is currently being revised to address recent scientific advancements. We'll discuss the expected changes and potential impact on viral safety strategies.

Even the strongest study design may encounter issues with sufficient clearance to reach the target safety expectations. Learn how to troubleshoot these and manufacturing deviations that impact viral safety.

The  Blazar™ Rodent Panel from the BioReliance® portfolio can speed cell line characterization and bulk harvest lot release testing. This degenerate PCR-based method accelerates characterization by reducing timelines by up to 80% and replaces the use of animals.

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.

Many of the methods used for biosafety testing are decades old. In this talk we explore new methods that 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.

How to accelerate viral detection from weeks to just days? This one-minute video introduces you to Blazar™ Platform. This rapid molecular platform combines the speed and sensitivity of PCR with the breadth of detection normally associated with Next-Generation Sequencing. A highly multiplexed degenerate PCR approach allows broad and sensitive detection of viral contaminants.

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.

CONTACT INFORMATION

MilliporeSigma

14920 Broschart Rd.

Rockville, MD 20850

UNITED STATES

Phone: +01 800 553 5372

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