Bioprocessing Application Notes & Case Studies

  1. Minimizing Errors And Saving Time In Drug Receipt Processes
    3/20/2019

    The speed-accuracy trade-off is a well-known phenomenon in psychology for processes requiring human input: the faster you go, the more likely it is that errors will be introduced into the system. This presents a major challenge for complex supply chains that demand both efficiency and accuracy. This case study shows the steps Fisher Bioservices took to improve efficiency and accuracy to combat the complexities of the drug receipt process.

  2. End-To-End Process For Oncolytic Adenovirus Production
    3/20/2019

    Oncolytic viruses constitute a new promising therapeutic approach for treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.

  3. Case Studies In Supply Chain Management: Getting It Right From The Start
    3/15/2019

    Consistent management and communication are the keys to success when managing the supply chain of any advanced therapy clinical trial. In this article, we’ll review two case studies that demonstrate the importance of supply chain management by focusing on scaling up for commercial distribution and on packaging challenges within a cryogenic environment.

  4. Adenovirus Production In Single-Use ReadyToProcess WAVE™ 25 Bioreactor System
    3/8/2019

    Using rocking bioreactor systems can shorten the seed train prior to inoculation and provide optimized growth conditions for sensitive cells. This study presents a robust production of adenovirus using a rocking bioreactor system.

  5. Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures
    2/26/2019

    One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.

  6. Scaling The Advanced Therapy Supply Chain
    2/13/2019

    Treating castration resistant prostate cancer means that failure within the advanced therapy supply chain has a catastrophic impact on patients. This case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.

  7. A Universal, Three-Step Chromatography Platform For mAb Purification
    1/29/2019

    This application note describes a flexible and scalable chromatography platform suitable for the purification of monoclonal antibodies of different isoelectric points (pI) and physical properties. 

  8. Model Extraction Studies Examined For mAb In Prefilled Syringe
    1/22/2019

    It’s been more than 30 years since monoclonal antibodies were first licensed for clinical use. But product developers are still inventing novel ways to improve their safety and efficacy.

  9. Extractables And Leachables Studies Support Single-Use Systems
    1/22/2019

    Concerns about leachables were expected to restrict adoption of single-use systems. This case study shows how far they’ve come.

  10. Production Of Human iPSC-Derived Cortical Neurospheres In A Mini Bioreactor System
    1/15/2019

    Stem cell-derived cortical neurospheres are of great interest in basic neurobiology research and drug research. Cultivation in controlled, stirred-tank bioreactors can improve the homogeneity of neural spheroid cultures and allows culture scale-up.