Search results for " comparability" in Articles / App Notes
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
“No, ” he said, “This is not really any different than the requirement for characterization of a new product—except, of course, one must demonstrate comparability or biosimilar similarity to an existi…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
This necessitated modifications to the purification process, which eventually allowed demonstration of comparability to the innovator and approval by the EMA (51). The success of a biosimilar developm…
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Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
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Introducing Supor Prime Filters: A Filtration Solution for High-Concentration Therapies
As you may already know, many biopharmaceutical manufacturers are producing drugs at higher concentrations. This trend is mainly driven by the demand for subcutaneous drugs that are self-admin…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…
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Webinar: Intensifying downstream bioprocessing with continuous technologies
Webinar on June 20, 2024
Significant operational improvements can be achieved by intensified continuous processes compared to standard batch processes.
In this webinar we will explor…
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Exosome isolation by tangential flow filtration and size exclusion chromatography
We demonstrate a scalable workflow for the isolation of exosomes—a type of extracellular vesicle with significant potential for targeted drug/gene delivery. For research and development and di…
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Bracing for a Future Wave of Advanced Therapies
With the help of recent investor interest, progression of advanced therapy medicinal products (ATMPs) in the clinical space continues to move forward. Buoyed by the regulatory approval of sever…
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Top challenges in recombinant protein purification process development
In this video, Emma Lind, Product Manager for Chromatography Resins at Cytiva answers questions from BioPharm International about the challenges faced by process developers working with recombi…
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Digitalization: The Route to Biopharma 4.0
Side-by-side Comparability of Batch and Continuous Downstream for the Purification of Monoclonal Antibodies. Biotechnol. Bioeng. 2020, 117 (4), 1024–1036.
19. Fisher, A. C.; Kamga, M. H.; Agarab…