Biosimilar Development solution center

  1. Biosimilars: Not Just Big Pharma’s Playground

    In addition to discussing past challenges, two experts from NeuClone provided me with a number of the critical analytical, manufacturing, and clinical considerations that are important to make for any company — but especially for smaller companies — when developing biosimilars.   

  2. EMA Update: What Challenges Are Biosimilars Bringing To The Table?

    One EMA regulator brought up several points at a recent conference that stood out, either as bright spots to boost industry morale, or that emphasized where the industry needs to focus its energy to pave the way for future regulatory reform.

  3. Sterile Injectable Outsourcing Trends: What Biosimilar Developers Must Know

    Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.  

  4. Unexpected SEC Results – Can It Be Improved?

    Sometimes your size exclusion chromatography (SEC) results don’t look like you want them to. Fix issues like poor resolution, peak tailing and fronting with the tips in this FAQ.

  5. Master Analytical SEC Running Conditions

    Need to find out how to calibrate your size exclusion chromatography (SEC) column? Or how different additives affect your results? Read these useful insights.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.