Outsourced Pharma White Papers
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Efficient, Large-Scale Transfection Of T-Cells Using Flowfect® Technology
2/26/2023
The objective of this study was to test transfection of T-cells with GFP mRNA for evaluation of cell viability, transfection efficiency, and post-transfection growth using Kytopen’s Flowfect® technology.
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Is Mannitol Hemihydrate Detrimental To Protein Stability?
12/8/2023
Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.
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Using Next Generation Sequencing Methods For Virus Vector Identity Testing
9/7/2022
Sequencing techniques play a crucial role in establishing the quality attributes of a variety of therapeutic products. Learn what advantages NGS offers for obtaining accurate sequences.
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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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Navigating The Regulatory Maze: Fundamentals For Drug Development
7/15/2022
Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey.
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Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products
2/15/2023
Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
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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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Switching From Vials To PFS And Intravenous To Subcutaneous Formulations
7/25/2023
Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.
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Recommendations For Successful IND Approval Of RNA-LNP Drugs
8/22/2023
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
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Mycoplasma Contamination In Biopharmaceutical Manufacturing
2/9/2024
Learn how following strict laboratory practices and conducting routine testing for Mycoplasma contamination using nucleic acid-based assays can help ensure the production of safe and high-quality biopharmaceutical products.