Application Notes & Case Studies

  1. The Influence Of Roller Compactor Process Parameters On Granule Properties

    Processing powder blends can present a number of challenges: component powders may be poorly flowing in the process, the blends may be susceptible to segregation, or the formation of agglomerates may affect homogeneity. It is essential to identify powder properties that can be applied to characterize dry granulates in a relevant way, and to optimize dry granulation processes. This application note details investigates how process parameters influenced the properties of the dry granulate of a placebo formulation.

  2. New Method To Quantify Redispersion Potential Of Al Salts In Vaccines

    Adjuvants such as aluminum salt (Alum) are commonly added to vaccines to enhance their immune responses. A resulting sediment can be more or less compact and difficult to redisperse depending on the strength of the bonds between particles. In this note, we propose a rapid evaluation method (less than 30 minutes) of the sediment redispersibility.

  3. Predicting Flow Performance In Screw Feeders

    Across the powder handling industries screw feeders are used to control the flow of material from a dispenser or hopper into a process. The properties of the powder have a direct impact on the performance of the feeder making it essential to tailor the design and operating conditions of any given system to the specific powder being handled. A poorly matched powder/feeder combination will typically be associated with low feed rates, high screw torques and the accumulation of powder on the auger walls. All these factors decrease both short and long term operating efficiency.

  4. An End-To-End, Semi-Continuous Process For mAb Production

    See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.

  5. S.U.B. Enhancements For High-Density Fed-Batch Cultures

    Improvements in single-use systems have allowed implementation of high-demand cultures in emerging bioprocess workflows, while progressive advances in media optimization and improved clone genetic selection have underscored the perceived performance limitations of single-use bioreactors (S.U.B.s). This study presents how strategic enhancements of Thermo Scientific™ HyPerforma™ S.U.B.s have revealed improvement in mixing and mass transfer performance compared to legacy S.U.B. designs.

  6. Enhanced Single-Use Bioreactor Performance For Scalable Vero Cell Culture On Microcarriers In Serum-Free Medium

    Adherent cell cultures, such as those with Vero cells, are often more challenging than their suspension-based counterparts with scale-up methods that require optimization of agitation and other operating parameters. This application note presents how Thermo Scientific™ HyPerforma™ Single-Use Bioreactors (S.U.B.s) can be enhanced for scaled-up growth of adherent cells on GE Healthcare Cytodex™ 1 microcarriers in serum-free medium, in culture volumes of 50 L, 250 L, and 500 L.

  7. A Proven, Cost-Effective, Single-Use Powder Transfer Solution

    Single-use transfer technology has been used in biopharma manufacturing for years. However, upstream powder-handling processes haven’t been improved upon. Now, the industry is seeing a need for better ways to bring powders to the hydration process and begin upstream biologic manufacturing.

  8. What Cleanroom Build Method Is Best For You?

    Your future cleanroom is a critical asset, it is not just another construction project. The investment you make in the cleanroom facility is significant and it should perform for years to come. Learn the relative strengths and weaknesses of various cleanroom construction methodologies that are being implemented within the marketplace.

  9. Custom Designed Clinical Manufacturing Cleanrooms For Penn Medicine’s Cell And Gene Therapy Operations

    A GMP manufacturing suite was developed from its inception by AES, which included a custom-designed and constructed Clinical Manufacturing cleanroom core for producing PENN Medicine's cell and gene therapy candidates.

  10. Purposeful Design And Development Of A Next-Generation Single-Use Bioprocess Film

    Fortem film development is an important investment by GE Healthcare, as it helps meet the industry need for a fully characterized platform film across all bioprocessing applications with supply chain transparency as a focal point.