Biosimilar App Notes & Case Studies

1. Developing A Large-Scale Tangential Flow Filtration Process 5/13/2024

   Discover a process that can be modified to fit your downstream process and serves as a complete solution for concentration and diafiltration.

2. Automated Cell Washing And Formulation In CAR T Cell Therapy Manufacturing 6/14/2024

   Explore data collected from a study utilizing healthy donors in a typical CAR T cell processing workflow without a transduction step from a cross-site validation study.

3. A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation 1/15/2025

   Discover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.

4. Media And Buffer Mixing Using The Xcellerex™ Magnetic Mixer 6/19/2024

   A common requirement for media and buffer preparation in biopharma processing is powder-liquid mixing. Review the performance of a 3000 L single-use mixing system for preparing aqueous solutions.

5. Accelerating The mAb Formulation Process 5/7/2024

   Learn about a one-step process that was developed to streamline formulation, effectively reducing timelines from approximately 14 weeks to 8 weeks for this critical step.

6. Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges 7/21/2023

   Despite the momentum of the RNA-LNP therapeutic market, significant manufacturing challenges remain. However, the right mixing could solve three of these key challenges regarding instrumentation.

7. Mobius® ADC Reactor Performance 10/22/2024

   Learn about a family of single-use ADC reactors that has been developed to offer a safer and more efficient ADC production method than traditional mixing systems and meet the industry's growing needs.

8. Lipid Nanoparticle Compositional Analysis By UHPLC-CAD 6/30/2023

   Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.

9. Accelerating Bulk Harvest Testing Using A CHO Animal Origin Free Virus Panel 10/19/2023

   Here, we describe the design and performance of a degenerate PCR-based approach to broad virus screening that can be used in testing bulk harvest material derived from CHO cells.

10. Real-Time And In-Line Raman Spectroscopy For Glycan Quality Analysis 6/14/2024

    This study details the use of in-line Raman spectroscopy to monitor mAb glycan profiles within a production bioreactor, highlighting its potential for automation and customization.