Drug Development White Papers & Articles
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Key Stages In mRNA-Based Therapeutic Development
9/13/2022
Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.
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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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Partnering With Clinicians To Improve Pediatric Formulation Development
6/13/2022
Greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products.
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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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GMP-Validated Adventitious Virus Testing By Next Generation Sequencing
6/6/2022
Gain required knowledge related to the involved regulatory authorities and scientific technologies and disciplines: Next Generation Sequencing (NGS), Bioinformatics and Computer System Validation (CSV).
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Remote Access And Monitoring Of Bioprocess Unit Operations
5/26/2022
Digital transformation projects require a scalable connectivity solution for the manufacturing floor that is easily and rapidly deployed. Explore elements that enable connectivity among equipment.
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Patient-Centric Oral Solid Dose Formulation
5/17/2022
Gain insight into the systematic application of patient centricity to the design of OSD products.
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mRNA Vaccine Development: Planning, Workflow, Supply Chain Success
5/17/2022
A review of insights derived from the development of mRNA-based COVID-19 vaccines and how they can be applied to accelerate progress in the manufacture of vaccines and therapeutics moving forward.
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Continuous Manufacturing And Late-Phase Strategy: The Time Is Now
5/17/2022
Explore recent progress in continuous manufacturing and guidance for answering key questions related to implementation of continuous processing for late-phase development.
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The Changing Landscape Of Oncology Drug Development
5/17/2022
Discover the guidance for navigating unique formulation and handling requirements, novel trial designs and supply chain implications, and regulatory and clinical strategies to support product approvals.