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Biosimilarity Assessments: The Totality of Evidence Framework

SponsoredThis article describes biosimilarity assessment approach applicable to comparability of lifecycle assessments and compliant with the US FDA’s totality of evidence concept.

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eBook: Bioreactor Scale-Up: From Pilot to Commercial Scale in the Modern Era

This online exclusive reviews the science and technologies affecting upstream process development, with a focus on bioreactors and flow geometry.

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Emerging Treatments for Spinal Cord Damage

This article explains why nerves damaged by spinal cord injury don’t regenerate and explores emerging treatments for spinal cord damage.

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Pfizer unveils biosimilar launch plans and shares view on US market

Pfizer set out a busy programme of biosimilar launches in its Q3 call and shared its thoughts on challenges facing the US market.

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CMC Considerations for Commercial-Ready ADC Manufacturing Processes to Enable Accelerated Timelines

SponsoredAt the CPhI Theater in May 2019, Courtney Morgret, PhD, senior scientist at ABBVIE, shared some key CMC considerations for antibody-drug conjugate products.

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Streamlined Serum-Free Adaptation of CHO-DG44 Cells: Using a Novel Chemically Defined Medium

This article details a streamlined protocol for serum-free adaptation of CHO-DG44 cell lines from adherent, serum-supplemented culture to suspension culture in a fully defined chemical medium.

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A Faster Solution to Hybridoma Screening

SponsoredIn this special report ModiQuest Research applies Intellicyt? iQue technology in its hybridoma screening process. The iQue3 system expedites the discovery of antibodies through improved screening of antigen presentation during stable cell line generation, sera evaluation, and hybridoma selection.

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Control of Protein A Column Loading During Continuous Antibody Production: A Technology Overview of Real-Time Titer Measurement Methods

This technology review explores ways to control protein A column loading by using real-time titer measurement during continuous antibody production.

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