Podcast
Strategies for Testing Host Cell Protein
Summary: The FDA requires that host cell proteins (HCPs) be reduced to low levels because they can affect the safety and efficacy of a drug. Pharmaceutical Technology recently spoke with...
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Article
Gene Therapy - Unprecedented Growth and Challenges
Summary: Gene therapy is a rapidly growing area in healthcare but, now the promise has been shown, we must focus on improving the manufacturing process and reducing...
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eBook
Frontiers in Binding Assays and Bioassays
Summary: Bioassays and binding assays play a critical role in ensuring product quality, safety and efficacy.
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Webinars
The Do’s and Don’ts of Managing a Pivotal Gene Therapy Trial
Summary: Gene therapies have been exploding in popularity and lining up new programs looking to create a new standard of care models for a wide variety of diseases.
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Article
From Basics to Best Practices: Exploring Bioassays and Binding Assays
Summary: Analytical testing for biologics is evolving rapidly as new protocols become available and companies seek to expedite current methodologies.
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Article
Strategies for Testing Host Cell Proteins
Summary: The FDA requires that host cell proteins (HCPs) be reduced to low levels because they can affect the safety and efficacy of a drug. Pharmaceutical Technology recently spoke...
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Infographic
Infographic: Bioassays and Binding Assays
Summary: Download the infographic to learn more about the latest cell-based bioassays and binding assays with an emphasis on their applications in the industry.
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Article
Strategies for Successful Transition of a Biologic Assay
Summary: Patient centricity has always been at the heart of the pharmaceutical industry. With rising costs of drugs and healthcare, there has been...
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Article
Quantification and Characterization of Polysorbate-80 in Protein Formulations
Summary: In this article, Luke Deters, Director of Biologics, discusses an appropriate method for quantification and characterization of polysorbate-80 (PS-80), a commonly-used, but highly-heterogenous, surfactant...
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White Papers
Regulatory Support
Summary: Our regulatory team completes over 150 agency submissions each year, supporting all stages of the product lifecycle. We assign a dedicated regulatory professional to each of our clients...
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