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Bioanalytical Strategies for Advanced Therapies

As the cell and gene therapy market continues to grow, analytical science will play an increasingly important role.

Released By Catalent

Analytical Science: Evolving and Adapting for Advanced Medicines
In the last 10 to 15 years, the pharmaceutical industry has made significant strides in leveraging the full potential of cell and gene therapies, as several products have successfully made it through clinical development to approval.
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Analytical Considerations in the Lifecycle Management of Biologics
Biologics represent a growing sector of the pharmaceutical industry. They are medicinal products derived from various natural sources and extracted or produced by genetic engineering techniques or other technologies.
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The Design of Experiments Approach to Analytical Method Development
The European Medicines Agency (EMA) defines the quality by design (QbD) approach as one that aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development and manufacturing of medicines.
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Leveraging Novel Analytical Approaches for Advanced Therapies
Small molecule-based drugs were the primary choice of physicians for the treatment or prevention of disease, until monoclonal antibodies were added to their arsenal with the first approval in 1986
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