Outsourced Pharma App Notes & Case Studies

81. Improve Bioprocessing Efficiency With A Standardized Automation Platform 3/9/2021

    Designed specifically for the biomanufacturing industry, Cytiva's Figurate automation is a portfolio of automation platform solutions powered by the reliability of Emerson’s DeltaV.

82. Probing The Source Of An Unstable Impurity And Controlling Its Formation At Release 4/19/2021

    A critical step in an extended-release drug product analysis is the extraction during impurity and assay sample preparation. When both the drug substance and the impurity are unstable, this is especially challenging.

83. Standardizing Process Characterization And Late Phase Development 11/18/2019

    For therapies with early success now progressing toward commercial manufacturing, understanding the operational, regulatory, and quality connections is critical for successful filing and launch. This case study proposes an approach for process characterization to produce a monoclonal antibody, specifically at the drug substance biomanufacturing step, to improve efficiency and effectiveness.

84. Liquid Nitrogen-Free Cryopreservation For Sustainability 4/5/2021

    This study focuses on the running costs and carbon emissions associated with cryopreservation equipment, comparing a liquid nitrogen (LN₂)-free controlled-rate freezer with a typical liquid nitrogen-based system. The environmental implications of using liquid nitrogen for cell freezing are explored along with carbon emissions during the manufacture, transportation, and operation of LN₂-free controlled-rate freezers.

85. Pluripotent Stem Cell Expansion And Scale-Up 8/5/2020

    Upstream process development is complex for stem cell therapies, because these therapies involve many manipulations during cell differentiation or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.

86. Accelerating Results For Healthcare Brands Through Advocacy, Materials Science Expertise And Integrated Packaging Capabilities 4/15/2021

    Any change to packaging design for an approved pharmaceutical product is a time consuming, detail-orientated effort, even with small brand-driven changes––so when governments update packaging regulations on a larger scale, a company’s entire product line could be impacted, creating change management projects for sometimes hundreds of items. When Health Canada introduced amendments to the existing Food and Drug Regulations for non-prescription, over-the-counter (OTC) drug products in 2014, pharmaceutical organizations selling products in the Canadian marketplace knew they had a significant challenge to overcome

87. Delivering Clinical Trial Medications Direct-To-Patient 10/15/2020

    In a perfect world, patients enrolled in clinical trials would live a short distance from the investigator site where they receive their treatment. Unfortunately, that is not always the case. In recent years, the direct-to- patient model, which brings medical procedures to a patient’s home, has emerged as a solution for sponsors to increase patient recruitment and retention in clinical trials.

88. CMOs Continue To Exceed Sponsor Expectations 3/5/2021

    ISR explains how the CMO Leadership Awards and the corresponding market research data can be used to make more informed CMO selection decisions and optimize operational and marketing strategies.

89. Meet The Scientist — Bryan Braxton, Ph.D. 2/5/2021

    Bryan Braxton has a friendly, grounded demeanor and a scientific mind that creates solutions for our most complex aseptic development projects. But how did these two traits combine in the same person?

90. CAR-T Cell Lentiviral Transduction By Spinoculation 5/21/2020

    There is a growing need to close and automate manufacturing of chimeric antigen receptor (CAR)-T cell therapies. Learn how to streamline this step while keeping flexibility during process development.