Biosimilar App Notes & Case Studies

  1. Key Insights Into Overcoming mRNA Process Challenges 9/8/2021

    Realizing the potential of mRNA requires focus on key areas and strategies that could help alleviate the bottlenecks in this growing market segment.

  2. AVROBIO’s Geoff MacKay On Cell & Gene Scalability 10/4/2021

    Geoff MacKay, president and CEO of AVROBIO, talks with The Business of Biotech podcast about the scale up obstacles facing the cell and gene therapy space and how AVRO is working to tackle them.

  3. Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage 3/24/2023

    Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.

  4. How To Ensure Correct Component Selection When Outsourcing To A CMO 3/22/2023

    A CMO-recommended lyophilization stopper was contributing to several operational inefficiencies, including sticking and interlocking of stoppers during filling operations. Requalification work was required to make a change.

  5. Building An Army: Cell Therapy Platforms With Dr. Helen Sabzevari, CEO Of Precigen 8/18/2021

    Two of the biggest challenges facing the cell and gene therapy space today — controlling costs and optimizing scalability — have the potential to be addressed by companies through innovative, integrated technology solutions. In a recent episode of The Business of Biotech, Dr. Helen Sabzevari discussed how her company Precigen has used customized therapeutic and platform technologies to tackle scale-up in the CAR-T therapeutics space.

  6. Automated Bag Thawing System For CAR-T Cell Therapy Manufacturing 1/11/2022

    The performance of the VIA Thaw CB1000 is compared to thawing in a water bath. The VIA Thaw™ dry thawing system shows comparable performance to a water bath with less handling.

  7. Recombinant Adeno-Associated Virus Type 5 Production Process 10/12/2022

    Learn about a scalable process for the production of rAAV using triple plasmid transfection of suspension cells in an animal-derived component-free medium.

  8. Apply For A Breakthrough Therapy Designation (And Win It!) 10/4/2021

    GlaxoSmithKline's Dr. Ira Gupta and Gilead Sciences' Dr. Shanthi Ganeshan break down breakthrough designations, winning them, and bouncing back from rejection.

  9. Maximize Product Recovery In Bulk Filtration And Filling Flow Paths 12/15/2022

    Explore a fill system designed to automate product draining and recovery within a batch to standardize processes and minimize non-recoverable hold-up within the filtration and distribution flow path sections.

  10. The Importance Of CMC Developability Assessments 10/4/2021

    Why the business case for any therapeutic starts with a CMC developability assessment and why it’s important to understand your end game as early as discovery.