Biosimilar App Notes & Case Studies

1. Improve Bioprocessing Efficiency With A Standardized Automation Platform 3/9/2021

   Designed specifically for the biomanufacturing industry, Cytiva's Figurate automation is a portfolio of automation platform solutions powered by the reliability of Emerson’s DeltaV.

2. Security Of Supply In Cell And Gene Therapy Manufacturing 9/24/2020

   With so many challenges in cell and gene therapy manufacturing, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs.

3. Low-Risk Approach For Process Transfer From Development To Manufacturing 8/17/2020

   This paper explores one approach for overcoming several scale-up issues with the use miniature bioreactors for process development.

4. Automated Glucose Control 7/9/2019

   This application note documents an example method for establishing glucose feed control and highlights the key benefits of applying said method to other processes. 

5. Automated Cell Bleed Control In An Intensified SU Rocking Motion Bioreactor 11/20/2019

   Intensified processing increases the productivity of single-use facilities and decreases the manufacturing footprint. Here's how to optimize the approach.

6. Precise Control Of Gas Flows Within The BIOSTAT B-DCU 7/9/2019

   This application note demonstrates the performance of a new generation of mass flow controllers in the BIOSTAT B-DCU bioreactor system. Several comparative cell cultivations were performed.

7. Scale-Up Of CHO Cell Fed-Batch Cultures 2/21/2020

   This application note compares cell growth and recombinant protein production of multiple CHO cell clones when cultured in HyClone ActiPro basal medium and Cell Boost 7a and 7b feeding supplements.

8. Protein A Resin Reduction Achieved With Process Transfer From Batch To BioSMB 6/7/2021

   A biopharmaceutical manufacturer was looking to reduce the operating costs of existing purification steps with high resin costs. In this case study they review transferring an existing batch chromatography process into a multi column format and then scaling up that process to an continuous perfusion run. The result was a dramatic reduction in protein A resin requirements.

9. Quality-by-Design Approach To Enable High-Dose Drug Delivery With Autoinjectors 5/12/2021

   Designing self-injection systems to deliver biological drugs into the subcutaneous space has specific challenges relative to those required for the safe and efficacious delivery of traditional pharmaceuticals. A quality by design approach can manage all the unavoidable competing requirements and balance performance, robustness, and usability.

10. Effectively Managing Data In Process Development 1/11/2021

    Addressing data management challenges during drug development requires an understanding of today’s shortcomings and the factors to consider when adopting a solution to overcome them.