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Technical Notes

20 10, 2025

Technote: Clarifying Suitability Testing: A Common Source of Misunderstanding in Regulated Assay Work

2025-12-23T18:15:47+00:00

Download our technote, Clarifying Suitability Testing: A Common Source of Misunderstanding in Regulated Assay Work, to better understand the distinct roles of method suitability, matrix effect evaluation, and system suitability testing (SST) in regulated analytical workflows. This resource explains how these tests differ, where they overlap, and how they should be applied to meet FDA, EMA, and ICH requirements...

Technote: Clarifying Suitability Testing: A Common Source of Misunderstanding in Regulated Assay Work2025-12-23T18:15:47+00:00
20 10, 2025

Technote: Successful Development of Cell-based Potency Assays

2025-12-23T18:16:02+00:00

Download our technote, Successful Development of Cell-based Potency Assays, to explore the essential role of potency assays in evaluating the biological activity of complex therapeutics, including cell and gene therapy products. This comprehensive guide draws on our extensive experience designing and validating custom potency assays, offering practical insights into assay formats, MOA selection, and relative potency determination...

Technote: Successful Development of Cell-based Potency Assays2025-12-23T18:16:02+00:00
20 10, 2025

Technote: Implementing Data Integrity and 21 CFR Part 11 Compliance in NGS Workflows

2025-12-23T18:18:18+00:00

Next-generation sequencing (NGS) technologies are transforming regulated drug development by enabling high-resolution analysis for applications such as gene editing, adventitious agent detection, and sequence confirmation. However, integrating NGS into GMP and GLP workflows introduces significant challenges related to data integrity and compliance with 21 CFR Part 11. These regulations require strict controls over electronic records...

Technote: Implementing Data Integrity and 21 CFR Part 11 Compliance in NGS Workflows2025-12-23T18:18:18+00:00
20 10, 2025

Technote: qPCR or ddPCR for Bioanalysis

2025-12-23T18:18:32+00:00

Dive into the comparison of quantitative PCR (qPCR) and digital droplet PCR (ddPCR), uncovering their strengths, limitations, and optimal applications. Backed by decades of experience, Avance Biosciences offers unparalleled expertise in both qPCR and ddPCR technologies, ensuring accurate results and compliance within regulatory environments. Discover the nuances between these methodologies and learn how to choose the right approach for your bioanalytical challenges...

Technote: qPCR or ddPCR for Bioanalysis2025-12-23T18:18:32+00:00
20 10, 2025

Technote: GUIDE-Seq/iGuide for CRISPR On/Off Target Analysis

2025-12-23T18:18:47+00:00

This guide provides an in-depth look at GUIDE-Seq/iGuide, a key technique for assessing CRISPR-Cas9 on- and off-target effects in gene and cell therapy development. It explains how the method informs the selection of gRNAs, nucleases, and CRISPR conditions to maximize specificity and safety. Readers will also gain insights into the full workflow, from Cas9 cleavage to NGS analysis, supported by Avance Biosciences’ expertise as a licensed GUIDE-Seq service provider...

Technote: GUIDE-Seq/iGuide for CRISPR On/Off Target Analysis2025-12-23T18:18:47+00:00
20 10, 2025

Technote: NGS for Biologics Development Support

2025-12-23T18:19:02+00:00

Explore the power of Next Generation Sequencing (NGS) for biologics development support with our latest whitepaper. Avance Biosciences is at the forefront of NGS testing, offering tailored solutions to support drug development initiatives and GMP manufacturing activities. Delve into real-world case studies, including CRISPR indel amplicon sequencing and insertion site studies, showcasing our expertise in assay development and validation...

Technote: NGS for Biologics Development Support2025-12-23T18:19:02+00:00
20 10, 2025

Technote: Phage Testing of Bacterial Cultures

2025-12-23T18:19:16+00:00

Download our whitepaper on “Phage Testing of Bacterial Cultures” to understand the critical importance of mitigating phage contamination in biotech and pharmaceutical industries. Learn about the lytic and lysogenic life cycles of phages, their role in bacterial biology, and the challenges they pose to the biotech and pharmaceutical industries due to contamination. Phage presence in cultures can significantly skew results, posing challenges in bacterial identification and isolation...

Technote: Phage Testing of Bacterial Cultures2025-12-23T18:19:16+00:00
14 03, 2024

qPCR or ddPCR for Bioanalysis? – Download our Comprehensive Guide

2025-12-23T18:45:11+00:00

This comprehensive guide explores the essential tools of quantitative PCR (qPCR) and digital droplet PCR (ddPCR) in the biopharmaceutical industry, offering invaluable insights into their applications, strengths, and limitations. Download now to stay ahead of the curve in pharmaceutical research and development...

qPCR or ddPCR for Bioanalysis? – Download our Comprehensive Guide2025-12-23T18:45:11+00:00

About Us

Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development. From early discovery through clinical development and commercialization, we provide CGMP and GLP-compliant services tailored to your therapeutic modality and regulatory needs.

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