Application Notes & Case Studies

  1. Process Economy Of Using Cytodex™ Gamma Microcarriers
    8/3/2018

    Microcarriers are commonly used in bioreactor cultures to provide a large growth surface for anchorage-dependent cells, and are typically provided either untreated or gamma-irradiated and ready for use. The process economy comparison performed in this work was made for the preparation step of Cytodex 1 versus Cytodex 1 Gamma microcarriers. Two scales were included: 100 L pilot and 500 L production scales.

  2. Accelerated Manufacturing Of Subunit Vaccines For A Rapid Pandemic Response
    8/3/2018

    This application note describes a process for rapid production of recombinant anthrax protective antigen (rPA) in short process time for the manufacture of an anthrax subunit vaccine. Histidine-tagged rPA was produced in Pseudomonas fluorescens grown in the singleuse Xcellerex XDR-50 MO fermentor system.

  3. Process Economic Simulation For Scalable Production Of Adenovirus
    8/3/2018

    This application note discloses process economic modelling of a modern start-to-finish adenovirus production process. The novel process was compared with a reference process in both stainless steel and single-use configurations across various production scales and scenarios. The process based on modern tools and technologies was generally shown to be the most cost-efficient option of the investigated alternatives. Process configurations using single-use equipment wherever possible were also shown to be more cost-effective than corresponding configurations using primarily stainless-steel equipment.

  4. Scalable Process For Adenovirus Production
    8/3/2018

    This application note describes a process for adenovirus production, from upstream cell culture to downstream purification, using modern tools and technologies. To demonstrate robustness of the upstream process, virus production in suspension adapted cells was performed in both rocking and stirred-tank bioreactors. The downstream process was carefully optimized to meet stringent regulatory demands on product purity and quality. Novel analytical methods were used in parallel with established techniques for comparison and to ensure accurate monitoring of the processed material. The novel process is easily scaled and compatible with both single-use and steamable hard-piped process equipment.

  5. Aseptic Sampling Best Practices - Endotoxin Binding Affinity
    7/24/2018

    This technical report describes a study to evaluate binding affinity of Control Standard Endotoxin (CSE) to different plastic sample collection containers.

  6. Extract Technology And Gericke Provide Custom Powder Processing And Containment Systems For Major HealthCare Provider
    7/17/2018

    Manufacturer supplies a turnkey solution of four custom pieces of ‘containment’ offloading equipment to a leading global health care provider.

  7. Comparison Of Helium vs. Microcurrent HVLD Leak Testing Technologies
    7/16/2018

    This study shows that HVLD can detect leaks down to the Maximum Allowable Leakage Limit (MALL) and arguably makes it one of the most sensitive leak test methods in the market.

  8. Pfizer Collaborates to Accelerate Approval of Biosimilar MAbs in China
    6/22/2018

    As Pfizer began its pursuit of delivering two biosimilar monoclonal antibodies (mAbs) in China, it sought a partner that could mitigate the risks of expanding into this region while also significantly reducing the development timeline. By leveraging the expertise of an experienced partner and the benefits of single-use technology (SUT), Pfizer was able to quickly establish a global footprint while also gaining a competitive advantage in an emerging market.

  9. Medtech Startup Gets To Market Faster With On-Demand Molding
    6/20/2018

    Invoy Technologies, a Medtech startup, plans to release a novel handheld breath analyzer that instantly measures fat burning with a data-driven coaching app to help users reach their goals.

  10. A Specialized Pharmaceutical Kit Assembly Solution
    6/1/2018

    Company launches a fast acting Insulin injector pen pharmaceutical kit into the U.S. market by utilizing the new bespoke Semi-automated Packaging System (SAPS) at Almac’s U.S. commercial packaging facility.