Author Sarfaraz Niazi questions the rationale for each type of clinical study conducted on biosimilar products, and offers an alternative testing strategy to shorten the period of biosimilar development.
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Host cell protein analysis using mass spectrometry can identify a wider range of HCPs without the need for specialized antibody reagents or product- or process-specific method development.
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Antibody-drug conjugates (ADCs) add an additional level of challenge to testing of biotherapeutics. Characterization of new innovators and biosimilarity assessment is more challenging than for antibody therapeutics.
A new plasma fractionation technique based on membrane electrophoresis has been developed, this technique is known as preparative isolation using membrane electrophoresis (PRIME).
The survey reveals many different outcomes of focusing on early stage development of advanced formulations, and the potential for overcoming drug development challenges.
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In this webinar series, three biologics subject matter experts will discuss critical considerations in their respective parallel processes: drug substance, drug product and clinical supply.
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In this webinar Jason Chiu from JSR Life Sciences presents the new Chromassette technology that enables high flow-rates for any type of resin regardless of bead rigidity or bed volume
