Expert Insights On Downstream Bioprocessing

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems 4/20/2023

    While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.

  7. Strategizing The Scale-Up Of Cell Therapy Manufacturing Capacity 4/19/2023

    Adaptimmune’s Mike Blankenstein, vice president of patient supply operations, discusses the team's manufacturing network strategy designed to evolve with them as the company grows from clinical to commercial supply needs, balancing cost and risk, while ensuring flexibility to respond to patients’ needs.

  8. Add Biologics Manufacturing Efficiency With Design Of Experiments, Part 2 4/5/2023

    By reducing the total number of experiments, design of experiments methods streamline process optimization. With fewer tests, drug makers can spend less of their budgets on screening and more on process characterization.

  9. A Brief Overview Of Vaccine Purification Technologies And Analytical Tools 3/23/2023

    Downstream processing remains a major bottleneck for vaccine production, and the industry is racing to develop new purification technologies. Here's a snapshot of where we stand and of what needs to happen next to increase quality and yields.

  10. Transitioning From Monoclonal Antibody To AAV Separation Science 3/16/2023

    Separation scientists jumping from mAbs to AAV inherently have advantages, but familiarity can also present roadblocks. Here are a few tips on leveraging past experience with mAbs when developing AAV gene therapy products.