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Significant changes have taken place in the life sciences industry over the past few years. Since the Covid-19 pandemic, the U.S. government has urged biotech and pharmaceutical companies to increase domestic production in order to secure the drug su...

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With the growing complexity of drug molecules and the need to involve newer and harsher reaction conditions that were once thought of as unfriendly in process chemistry, continuous flow chemistry and processing offer a proven alternative pathway.

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Often, aggressive timelines are imposed on development projects with the aim of getting to First-in-Human trials as soon as possible. However, formulation development can be met with many challenges as biologics are often sensitive molecules with a v...

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Watch this webinar to learn about a versatile peptide coupling & water removal reagent that offers several process advantages.

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The COVID-19 pandemic brought the global interdependency of pharmaceutical supply chains into sharp focus, exposing weak links and re-igniting discussions around the value of reshoring production. In this webinar we will discuss drivers to consider i...

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In this GEN webinar, our guest speakers, Dr. Tyler Jones and Senior Research Scientist Dylan Ting will discuss strategies to leverage efficiency from cell line development to clinical manufacturing of biologics. Moreover, we will hear how proprietary...

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The webinar focuses on truncating drug development timelines in the aftermath of COVID-19. The featured speaker emphasizes phase-appropriate development, offering creative solutions and round-the-clock development across various continents.

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This webinar will provide a general overview of mRNA therapeutics design and production and discuss the importance of robust quality systems in the context of GMP production of mRNA therapeutics.

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The objective of this webinar is to explore the QMM program and its benefits, including the rating system currently being developed by the FDA’s Center for Drug Evaluation and Research (CDER) to incentivize drug manufacturers to achieve QMM. We wi...

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To optimize manufacturing process performance and product quality, enhance supply chain reliability, and foster proactive continual improvement, the FDA’s Center for Drug Evaluation and Research (CDER) has established a program to promote quality m...

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The increasing global trade of pharmaceutical products underscores the need for (bio)pharmaceutical companies to be well-versed in international trade requirements. This white paper explores the impact of factors like the COVID-19 pandemic on global...

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While large molecules continue to advance in drug development pipelines, small molecule Active Pharmaceutical Ingredients (APIs) still retain their historical dominance among new drug applications (NDAs). However, the last few years have seen the lin...

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