Biosimilar App Notes & Case Studies

1. Effective Downstream Purification For A Clinical-Stage Retrovirus-Like Particle 10/7/2019

   Purification of enveloped viruses and virus-like particles is challenging due to their size and complexity. This study demonstrates resin screening, process development, and scale-up purification approaches. 

2. Embracing Biosimilars, They Are Here To Stay 10/10/2018

   The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.

3. Downstream Process Development For Efficient Purification Of Adenovirus 9/10/2018

   Here, we describe the development of two effective downstream processes for purification of adenovirus from cell culture harvest.

4. Purification Of An Acidic IgM For Large Biomolecule Purification 1/10/2019

   The large size of IgMs makes their purification very challenging. See how Bio-Rad's new strong anion exchange resin (AEX), Nuvia HP-Q, has the ability to overcome the multiple issues faced when purifying large biomolecules.

5. Why Invest In Emerging Markets Now 10/10/2018

   Unexplored and emerging markets are an attractive prospect for biopharma companies looking to expand. But when it comes to ensuring success, what’s the wisest way to invest?

6. Reducing Cost Of Goods For Gene Therapy 7/24/2020

   Frost & Sullivan recently invited industry leaders with gene therapy experience to participate in a new thought leadership forum, our Virtual Think Tank. This forum brought together leading minds in this emerging field to discuss key challenges and other insights related to reducing the cost of goods (COGs) for gene therapy.

7. Important Parameters For Packing Nuvia HR-S Resin At Process Scale 5/27/2020

   Process-scale production typically involves more than one column. The packing quality of each column affects the efficiency of the whole workflow and is an important validation criterion.

8. Expanded Droplet Digital PCR Multiplexing Capability Using Two Different Strategies 10/23/2019

   Droplet Digital PCR (ddPCR) enables easy multiplexing of numerous targets within each fluorescent channel. Amplitude-based multiplexing achieves this by varying primer and/or probe concentrations. In probe-mixing multiplexing, probes are mixed at desired concentrations to place targets in a defined position on a 2-D plot. This paper describes strategies for both approaches using the large portfolio of ddPCR Assays readily available through Bio‑Rad.

9. Cell Therapy Manufacturing Under GMP - How And When To Get Started 5/2/2019

   Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.

10. Determination Of Adenovirus Concentration Using Surface Plasmon Resonance 9/10/2018

    The performance of two assays for determination of adenovirus concentration based on surface plasmon resonance (SPR) is demonstrated in this application note.