Expert Insights On Downstream Bioprocessing

81. Preformulation Of Excipients In Biologics Development 9/28/2023

    Most of the instability problems of a drug product come from excipients, in particular, they come from impurities in excipients. Those issues are best cleaned up in the preformulation period to determine excipient compatability.

82. Guidelines For mRNA Drug Product Manufacturing And Quality Control 9/15/2023

    The lightning fast rise of mRNA raised the need for manufacturing standards and consensus on product quality attributes and test methods. This article provides perspective and insight on PQAs for mRNA vaccines and other mRNA-based products.

83. How To Implement Size Exclusion Chromatography And Mitigate HCP Risk 9/13/2023

    Research shows size-exclusion chromatography improves the host cell protein detection capabilities of liquid chromatography-tandem mass spectrometry. This guest article explores the strategy of using both to better understand HCP persistence in the purification process.

84. Comparing Alternative Viral Vector Purification Tech 8/25/2023

    Clarification of viral vector harvests is more complicated than mAb clarification. But, as with mAbs, the technology is advancing at a rapid clip. In part 2 of this series on modern purification technology, expert Jack Vicalvi discusses process schemes used for clarifying different types of viral vector therapeutics.

85. Comparing Alternative mAb Purification Tech 8/21/2023

    The science of purifying monoclonal antibodies has come a long way, and drugmakers have far more technology to choose from. Expert Jack Vicalvi explains the advantages of modern techniques, how they're different from traditional methods, and how they fit into overall process schemes.

86. USP Unpacks The Evolving HCP Identification And Quantitation Story Behind <1132.1> 8/18/2023

    Traditional ELISA methods can fall short of detecting some host cell proteins, so the United States Pharmacopeia has proposed a new general chapter to account for the increased use of mass spectrometry in conjunction with HCP ELISA.

87. Takeda's Green Approach To IG Purification And Filling 8/14/2023

    To secure its spot as a 2023 ISPE Facility of the Year Awards winner, Takeda Lessines made some big moves including building a wastewater treatment center on-site in Belgium and installing 8,000 solar panels. This Q&A is part of a feature series on select FOYA winners.

88. Mechanistic Modeling To Optimize rAAV Production For Gene Therapy 8/11/2023

    Current processes in recombinant adeno-associated virus (rAAV)-based gene therapy production are generally not readily scalable. A group of scientists and engineers at MIT collaborated with the team at UMass Chan Medical School to develop a mechanistic model for the intracellular phenomena occurring during baculovirus infection and rAAV virion production in insect cells. A free and user-friendly implementation of the model is available online, and you can use it to test a wide range of conditions and hypotheses.

89. Preparing A Framework For Artificial Intelligence And Machine Learning Validation: A 3-Step Approach 7/20/2023

    Experts say it would be foolish to ignore the impending AI/ML revolution. There's official guidance out there now on how to prepare, but waiting for a full framework from regulators would be a mistake. This article lays out some strategies for building a foundation to implement AI/ML into your processes.

90. Navigating The Pros And Cons In Annex 1's PUPSIT Requirements 7/12/2023

    Annex 1 made Pre-use Post Sterilization Integrity Testing, or PUPSIT, a requirement, and enforcement has begun in earnest over the last few years. This article digs into the problems that downstream filter manipulation can cause and questions whether the risks outweigh any benefits.