INSIGHTS ON CELL & GENE THERAPY DISCOVERY

• Avoid Costly Mistakes In Gene Therapy Process Development

  Success in the evolving and highly competitive gene therapy space requires navigating many uncertainties related to process development and manufacturing of adeno-associated virus (AAV) and lentivirus vectors. These tips will guide development and manufacturing teams operating on compressed timelines.  

• Quality Matters – SEC Analysis For Antibody Aggregates

  Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.

• Expanded Droplet Digital PCR Multiplexing Capability Using Two Different Strategies

  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.

• Performance Characteristics Of The First FDA-Cleared Droplet Digital PCR (ddPCR) IVD Assay For Monitoring Chronic Myelogenous Leukemia (CML)

  Most CML cases are caused by a translocation between chromosomes 9 and 22 that creates an abnormal fusion gene, BCR-ABL1. This poster explains how Bio-Rad’s QXDx™ BCR-ABL %IS Kit quantifies the amount of BCR-ABL1 transcript as a ratio of BCR-ABL1/ABL1, then returns the value of Molecular Response (MR) and on the WHO International Scale(IS). The QXDx software performs automatic data analysis and reporting, results are reported in %IS, MR, and copies values.

• EDGE Confocal Imaging Technology

  Increasingly, scientists are being challenged to study more biologically-relevant model systems, and this often means imaging thick, demanding 3D samples that may also be alive. Read how IRIS and EDGE confocal imaging can offer high contrast imaging of thicker samples.

• Improving Cell Image Analysis Workflows Through Machine Learning

  Artificial intelligence (AI) provides exciting opportunities for fast, accurate, and unbiased cell image analysis. Read this guide to machine learning in high content analysis and see the benefits AI can bring to your automated cell imaging.

• Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics

  Challenges exist when developing biologic drugs to be efficacious but safe. Novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.

• 3 Strategies To Use When Selecting A CRO For A Gene Therapy Study

  Many biopharmaceutical companies have made significant investments in research and the clinical development of gene therapies. For those working to develop and bring new gene therapy treatments to market, it is critical to select the right contract research organization (CRO) to conduct these studies. Here are three helpful strategies to follow when selecting a CRO partner.

• A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand

  An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.

• Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process

  This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.