Search results for " therapeutic" in Articles / App Notes

Article Q&As with Industry Leaders
…DNA Product Specialist, Cytiva Using Mechanistic Modeling in Process Development for Advanced Therapeutics  Felicity Thomas, Pharmaceutical Technology Europe Peter Guterstam, Pr…

Article Comparing Protein A Resins for Monoclonal Antibody Purification
With greater economic pressure on monoclonal antibody (mAb) production for therapeutic and research uses, antibody titers in mammalian cell culture have increased dramatically over the past 20 years. …

Article Elucidating Biosimilars Characterization
NIBRT: Differences regarding the approval process for small molecules as compared to recombinant protein therapeutics are reflected in the complexity that must be considered when comparing small-molec…

Article Bracing for a Future Wave of Advanced Therapies
Pricing pressure for innovative therapeutics remains a volatile situation in the US market but, by Hunt’s assessment, the CGT market is still in its early days and working through the business model. …

Article Report from the 12th Plasma Product Biotechnology Forum
SAb Therapeutics has several projects in the pipeline, spanning from Phase 1 to Phase 3 across three indications. This first session at the PPB meeting also included two “next generation” presentation…

Article Need solutions for large-scale production of mRNA-based molecules?
mRNA therapeutics offer precise and individualized therapy and avoid manufacturing issues associated with recombinant proteins. Compared with current therapeutics, mRNA production is more cost-effecti…

Article Regulatory Requirements for Safe and Efficient Biologic Drug Development
…4:36 - Common regulatory milestones that can turn into stumbling blocks for companies developing new therapeutics 7:12 - Best practices to navigate the regulatory approval path 9:44 - The…

Article Updating Viral Clearance for New Biologic Modalities
… removal are well established and their effectiveness has been confirmed by the safety record of the therapeutics they were used to manufacture, adds Darren Verlenden, head of BioProcessing at Millip…

Article Next Generation Process Chromatography
Without it the industry would not be able to produce therapeutics in an economic manner. This is true for monoclonal antibodies (mAbs) that present the modern age in terms of fighting diseases such as…

Article Biosimilar Quality Requirements
In May 2019, the agency published the draft guidance Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations (1) and the guidance Con…

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