Biosimilar Development solution center
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Real-Time And In-Line Raman Spectroscopy For Glycan Quality Analysis
6/14/2024
This study details the use of in-line Raman spectroscopy to monitor mAb glycan profiles within a production bioreactor, highlighting its potential for automation and customization.
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Fab Fragment Development And Manufacturing For Clinical Trials
6/12/2024
Explore the outcomes of implementing an accelerated approach to process development and manufacturing for a project that was crucial for the future of Acticor Biotech and its therapeutic candidate.
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Revolutionizing Drug Discovery From "Undruggables" To AI
6/10/2024
Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.
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The Growing Demand And Applications For HPLC
6/6/2024
High-performance liquid chromatography offers more features compared to other analytical techniques, and the industry is finding more valuable ways to use it.
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Overcoming The Solubility Challenges Of Antibody-Drug Conjugates
6/3/2024
Discover a chito-oligosaccharide that significantly improves the solubility of antibody-drug conjugates (ADCs) when included in the linker-payload construct.
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Efficacy Screening Of Antibody-Drug-Conjugates By Surface Plasmon Resonance
6/3/2024
Rapid screening of ADC affinity using surface plasmon resonance provides preliminary efficacy data in comparing antigen binding affinity with selected linkers and payloads to the non-conjugated antibody.
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Establishing Commercial Manufacturing Services For ADCs
6/3/2024
Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.
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Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies
5/24/2024
The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3.
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New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies
5/16/2024
The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.
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Viral Vector Producer Cell Lines: Learning From mAbs
5/7/2024
Learn how applying bioprocessing knowledge from the production of mAbs can accelerate the development of viral vector cell lines and improve efficiency in gene therapy manufacturing.