Industry Insights

81. A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies 2/21/2024

    Establishing a robust contamination control strategy for advanced therapy medicinal products, also referred to as cellular and gene therapy products, is of utmost importance. We must employ risk assessments and risk-based approaches. In this article, the authors introduce the aseptic risk evaluation model (AREM), which is compliant with the evolving global regulatory landscape and best practices.

82. Microbial Expression System For Efficient Production Of Therapeutic Proteins

    The combination of unique and proven plasmids, fast process development, and automated downstream analysis ensures rapid progression from gene to optimized, high-titer fermentation process.

83. Overcome Complex Protein Challenges With Optimized Expression

    Realizing the potential of next-generation molecules calls on appropriate expression technologies and development processes that can facilitate their path to market.

84. Contract Manufacturing In China 12/4/2012

    The outsourcing of pharmaceutical manufacturing is growing most rapidly in Asia. Recently, PriceWaterhouseCoopers named China as the most attractive Asian country for outsourcing. At present, more than 100 drug manufacturing sites in China are manufacturing API or finished products for approved branded and generic drugs. By Oliver Mueller & Clifford Mintz, PhD

85. Achieving Flexibility In RNA Drug Manufacturing With Microfluidics 11/21/2023

    RNA manufacturers need flexible processes and technology. They need to manufacture high-quality RNA in small quantities and scale up. Modular, and more specifically, modular microfluidics equipment makes that easier. This discussion takes stock of the current state of modular equipment for RNA manufacturing.

86. The Path To Regulatory Approval For AOCs 4/14/2025

    The development and manufacturability of antibody-oligonucleotide conjugates hinges on understanding and overcoming intricate chemistry and technical challenges.

87. Drug Formulation Development: Quick Reference Guide 7/11/2022

    This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.

88. Chugai's Race To Zero Emissions At UK4 In Tokyo 6/21/2024

    Chugai's sustainable model led the construction of a new DS/DP manufacturing site, UK4, in Tokyo. The company focused on eliminating three key emissions sources.

89. Building Clinical Supply Agility In A Changing Trial Landscape 1/26/2026

    Rising trial complexity demands agile supply built on integrated operations, solid planning, and fast issue resolution. Lean teams gain from partners providing flexibility, control, and global reach.

90. Stability Chambers: Testing, Equipment, And Uses 3/7/2023

    Performing stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.