Outsourced Pharma White Papers
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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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Quantitation Of Monoclonal Antibodies In Serum
2/8/2024
Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.
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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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Next Gen Plasmid Technology: Improve Performance, Safety, Manufacturing
1/17/2023
Nanoplasmids have paved the way for facilitating a wide range of cell and gene therapeutic applications. Gain an overview of a novel technology and specific benefits.
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Streamlining And Standardizing Cell And Gene Therapies From Process To Product
1/13/2023
Cell and gene therapies are transforming the lives of patients with various rare genetic diseases and more common conditions such as cancer. However, the rapid pace of scientific progress has overwhelmed supply infrastructure, creating pressures to scale manufacturing, increase capacity and meet a wide range of deliverable requirements.
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Assessing Reliability, Confidence, And Batch Variation In PPQ Runs
6/29/2023
Examine the procedures and benefits of two statistical methodologies and how new technologies are requiring a risk-based approach to calculate the necessary number of PPQ runs.
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Controlling Trace Impurities In Chemically Defined Media
4/10/2023
Discover a novel approach for manufacturing chemically defined media with precision control of trace impurities that utilizes innovative raw material analysis, data analytics, and a proprietary algorithm.
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Optimizing Lipid Formulations For Targeted RNA-LNP Applications
9/13/2022
Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.
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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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Digital Transformation: A Critical Component For CDMOs
6/21/2023
Learn how embracing the digital transformation is key for managing complexity of speed, service, quality, regulatory compliance, and capacity as well as the obstacles facing CDMOs looking to innovate.