Expert Insights On Downstream Bioprocessing

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Key Considerations In Selecting A Robotic Solution For Endotoxin Testing 7/6/2023

    The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.

  7. Advanced Approaches For AAV Empty/Full Capsid Characterization 6/15/2023

    Wondering which analytical method is best for measuring capsids in your adeno-associated viral vector? You have a lot to choose from. Novartis' Joseph Ong, Ph.D., explores 10 of them and discusses their attributes.

  8. All You Need To Know About Contamination Control Strategies, Part 2 5/22/2023

    In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.

  9. All You Need To Know About Contamination Control Strategies, Part 1 5/12/2023

    In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, Manufacture of Sterile Medicinal Products.

  10. A Digital-First Approach To Bio/Pharma Manufacturing Operations 5/10/2023

    Features such as real-time data monitoring, cloud solutions, and process integration comprise a digital operational excellence approach that adds value. But successful deployment of these and other digital solutions requires careful, cross-functional collaboration across the full life cycle of the project.