Expert Insights On Upstream Bioprocessing

  1. ICH Final Q13 Guideline For Continuous Manufacturing: What It Means 12/16/2022

    The International Council for Harmonisation released the final draft of its Q13 guideline for continuous manufacturing. It's yet another signal that global regulators see tremendous potential in CM. Here are the key takeaways.

  2. Cleanroom Gowning Programs Compliant With EU GMP Annex 1 12/15/2022

    Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.

  3. Help! The Particle Count Is Overwhelming Us! 12/12/2022

    Contamination issues can challenge any facility, especially legacy facilities and those with intense operational demands, financial pressure. Let's look at some of the most common particle origins and some solutions.  

  4. ICH Issues Draft Guideline On Viral Safety Evaluation Of Biotech Products 12/8/2022

    Viral contamination can affect raw materials, cell culture processes, bioreactor contamination, and downstream processing. ICH's new draft guideline titled Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin is available for public comment through the FDA (ending Jan. 14, 2023) and through the EMA (ending Feb. 10, 2023).

  5. Where Do We Stand On Adopting Continuous Manufacturing For Biologics? 12/5/2022

    Continuous manufacturing offers productivity and cost-saving benefits among other things, but technical and regulatory challenges have slowed uptake. Speeding up adoption will require innovation and knowledge sharing within the industry and regulatory support from the FDA.

  6. Modularity And Mobility Hold The Keys To Surge Manufacturing 11/30/2022

    When a global crisis or other demand calls for rapid mobilization, process equipment designed to be modular, multipurpose, and single-use all help with rapid scale-up.

  7. A Methodology To Support Particle Investigations In Biopharma Products 11/22/2022

    Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.

  8. Biology Meets Computer Science For Next-Gen Biologics Drug Discovery 11/15/2022

    We have entered a new age in biologics development, which is undergoing a technological revolution with an increasing focus on software-dependent and data-driven results. Integrating the biological and the computational creates a need for specialists working together in parallel.

  9. Assessing Quality Of Viral Vectored Vaccines 11/11/2022

    While viral vectored vaccines have been previously developed against Ebola virus, the COVID-19 vaccines were the first widespread global application of this vaccine platform. Adenovirus vectored vaccines have unique critical quality attributes that must be tested to ensure quality and safety.

  10. Cost-Effective Biomanufacturing Of Lentiviral Vectors 11/2/2022

    This article compares fundamentals of current and upcoming lentiviral production processes and highlight areas of improvement that would allow an increase in manufacturing cost-effectiveness. Strategies discussed are production methods, cellular platforms, and bioprocessing options.