Newsletter | August 20, 2020

08.20.20 -- Improving Biologics Development And Manufacturing With Characterization

Meeting Stability Testing Expectations In Today’s Complex Biopharma Landscape

What was once a check-the-box procedure in standard stability testing now requires a deeper understanding of the molecule, how it behaves, and, most importantly, what effect it has on the patient.

Process Impurities: Don’t Let PEI Or HCP Derail Your Biotherapy

View this webinar to learn product characterization strategies to de-risk manufacturing and detect and characterize host cell proteins and polyethylenimine (PEI) in monoclonal antibody (mAb) and cell and gene therapies.

How Molecular Structure Influences Potency Of A Therapeutic Biologic

View this webinar to 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.

Not Everyone Loves Surprises: Know Your ADC’s Critical Quality Attributes

The intrinsic complexity of developing and manufacturing antibody-drug conjugates (ADCs) creates major challenges when trying to bring life-saving therapies to market. Combating the challenges of developing and manufacturing ADCs requires robust product characterization throughout all phases of development.

Role Of Cell-Based Potency Assay In Functional Characterization Of Therapeutic mAbs

Because characterization and comparison of originator and biosimilar candidate monoclonal antibodies (mAbs) is challenging due to their complex and variable structures, a range of analytical techniques should be employed.

Mitigating Risk Through Product Characterization

In this webinar, multiple approaches to characterizing the physicochemical and structural attributes of therapeutic monoclonal antibodies (mAbs) is presented with a focus on how it influences the resulting biological activity.