Biosimilar App Notes & Case Studies

  1. Chemically Defined Cloning Medium For Quality, Regulatory Risk Mitigation 3/18/2022

    We review the performance and stability of a novel, chemically defined cloning medium that accelerates clone isolation, reduces the risk of variability in protein quality, and reduces impurities.

  2. In-Process Control Of pDNA Production On CIMac™ pDNA Analytical Column 6/10/2021

    As the demand for plasmid DNA (pDNA) based gene therapy and vaccines increases, large-scale, cost-effective, and reproducible pDNA production is required. The key to success is a real-time in-process control method that ensures a high percentage of supercoiled pDNA in the final product. Read how the CIMac™ pDNA Analytical Column allows the monitoring of degradation products (open circular and linear pDNA), the removal of impurities (RNA), and ensures that each production step yields the amount of supercoiled pDNA anticipated.

  3. Next-Gen Bioprocess Monitoring: Smart Data Management And Analysis 10/14/2020

    A new platform that includes digital technologies/data management, process analytical technologies and intensified processing will drive next generation bioprocessing.

  4. Improving Fed-Batch Yields Via Cell Culture Media 2/15/2022

    Explore media combinations, dynamic fed-batch feeding options, and feed screening strategies suitable for diverse cell lines and manufacturing scenarios and guidance for improving culture yield.

  5. Purification Of mRNA By Affinity Chromatography On CIMmultus® Oligo dT Column 6/7/2021

    Increasing demand for messenger RNA (mRNA) as therapeutic product requires efficient and scalable purification methods. In this application note a CIMmultus® Oligo dT, a monolithic stationary phase is used for purification of mRNA from a capping mix of Luc2 RNA. The large channels and convective mass transfer within the stationary phase eliminate shear forces and allow high flow rates, which leads to very short purification times and high recoveries.

  6. Process Considerations For Closed Connected Processing 12/22/2020

    By giving examples for the implementation of closed, connected processing in large-scale manufacturing, this paper will help you explore and assess options that work for your objectives.

  7. N-1 Perfusion High Inoculum Fed-Batch For Reduced COGS And Easy Retrofit 6/7/2021

    A mid-to-large biopharma wanted to increase productivity 2-3 times in their fed-batch facility and and also reduce their current cost of goods (COGS). With one small change in the upstream (USP) seed train, the customer was able to meet their goals.

  8. Overcoming Cell Therapy Supply Chain Challenges 5/11/2021

    For the industry to realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.

  9. Developing A Continuous Large-Scale Perfusion Cell Culture Process 9/25/2020

    The key benefits of perfusion processes are compact process design, flexibility, increased productivity, increased yield, and consistent product quality. 

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

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