Biosimilar App Notes & Case Studies

1. Robust Process Development For cGMP Manufacturing Of Cell Therapies 9/24/2020

   By leveraging early decisions around process development, quality assurance, and quality control strategies, you can set yourself up for a successful cGMP manufacturing workflow. 

2. A Novel CAR-T Cell Therapy Approach Using Fluorescence-Activated Cell Sorting And Stem Cell Transplantation 9/14/2020

   Successful chimeric antigen receptor- (CAR-) T cell therapy requires a target antigen that is unique to cancer cells. But what happens when there are no unique antigens? Researchers at Columbia University Medical Center addressed this problem by replacing healthy non-target cells with genetically modified versions lacking the CAR-T cell target (Borot et al., 2019). Their results, published in PNAS, may provide a new avenue for treatment of some types of cancer.

3. Sorting An Old Problem: Are Cells Stressed By Fluorescence-Activated Cell Sorting? 9/14/2020

   Fluorescence-activated cell sorting is a valuable tool for research, allowing separation of a mixture of cells into distinct populations for analysis. But could the physical forces of sorting stress the cells, altering their behavior and confounding experimental results? Andrä et al. (2020) found that although cell sorting activated p38 MAPK stress signaling, no functional or structural changes were observable. The results indicate that jet-in-air systems such as the Bio‑Rad S3e Cell Sorter do not alter cell behavior.

4. A New International Standard To Measure DNA? 9/14/2020

   The breadth of digital PCR (dPCR) applications continues to grow and fulfill critical scientific needs. One of the major advantages the technology confers is the ability to count nucleic acid molecules directly, rather than extrapolating quantity based on standard curves as with many other methods. By harmonizing diagnostic procedures on dPCR platforms, the scientific and medical communities can become more coordinated and efficient than ever before.

5. Modular Bioprocessing Alleviates Drug Manufacturing Woes 4/4/2019

   Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries.

6. Identifying Heterogeneity Within Rare Cell Populations By Pairing Single-Cell RNA-Seq With Cell Sorting 6/7/2019

   Studying biology at a single-cell level can provide crucial insights into how individual cells contribute to human biology and disease. Here we demonstrate that the resolution of single-cell RNA sequencing (RNA-Seq) can be greatly enhanced by adding a cell sorting step prior to RNA-Seq analysis.

7. Regulatory Challenges For Viral Vectors For Cell And Gene Therapy 7/24/2020

   Frost & Sullivan's Virtual Think Tank series brought together leading minds in the cell & gene space to discuss current regulatory issues and key challenges in viral vector manufacturing.

8. Pluripotent Stem Cell Expansion And Scale-Up 8/5/2020

   Upstream process development is complex for stem cell therapies, because these therapies involve many manipulations during cell differentiation or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.

9. Improved Process Economics Of Humira Biosimilar Purification 1/10/2019

   This application note proposes an alternate but equally effective approach to biosimilar purification, by substituting a less expensive ion exchange resin for the affinity capture step.

10. 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.