Outsourced Pharma White Papers
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Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility
2/15/2023
The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.
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Accelerating The Development And Production Of High-Quality Bispecific Antibodies
3/7/2024
bsAbs are revolutionizing medicine by targeting two disease mechanisms simultaneously. Learn how an innovative platform offers excellent pairing and significantly enhances productivity and quality.
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Optimization Of Hydrogen Peroxide Decontamination
6/6/2022
Understanding critical influencing factors of hydrogen peroxide bio-decontamination is key for reliable process parameters.
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Orthogonal Methods To Understand And Define CQAs Of AAV Therapies
2/24/2023
An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
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Advancing A LNP Formulation To Clinical And Commercial Manufacturing
3/21/2024
Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
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A Comparative Analysis Of Mixing Characterization Methods
7/19/2023
In the bioprocessing industry, there is no single, standard method for measuring mixing performance. Here, we investigate the four most widely used methods for measuring mixing time.
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Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization
8/25/2023
There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.
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Revolution In The EU Pharmaceutical Legislation Ahead
2/8/2024
Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.
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Intro To USP <1062> - What It Is And Why You Should Use It
7/20/2023
Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.
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Validated HPLC-UV Method For Quantification Of Paxalisib
1/18/2023
Examine research into the development and validation of a HPLC method for the quantitation of paxalisib in mouse plasma and its potential use for routine therapeutic drug monitoring.