Biologics quality control

Biologics quality control

Quality control (QC) is a critical component of biologics development and production, ensuring product consistency, safety, and regulatory compliance. As biologics become increasingly complex, from mRNA-based therapies to viral vectors and engineered cell lines, rigorous QC is essential throughout the development pipeline. Increasing regulatory requirements demand robust evaluation of Critical Quality Attributes (CQAs), making advanced analytical techniques more important than ever.
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OHMX.bio’s long-read sequencing approach

OHMX.bio applies Oxford Nanopore long-read sequencing technology as a central tool for the quality control of biologics. This platform allows for complete and highly accurate sequence analysis of complex biological products, including mRNA constructs, plasmids, viral genomes, and engineered cell lines. Long-read sequencing enables the direct detection of full-length molecules, structural variants, and epigenetic modifications in a single run, providing deeper insights than conventional short-read or PCR-based methods. This capability is particularly effective in assessing CQAs, such as sequence integrity and structural consistency.
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Viral vector solutions

mRNA solutions

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Nanopore sequencing

Plasmid solutions

Cell line solutions

Increasing regulatory requirements are driving the need for robust characterization of critical quality attributes (CQAs) in biologics, OHMX.bio offers expert QC solutions utilizing nanopore sequencing. Recent publications of the European Medical Association call for the use of sequencing as a useful alternative for traditional techniques. Click here if you are i nterested in more content related to mRNA.

Comprehensive applications across biologics

Our QC services support a wide range of biologic products:

mRNA Therapeutics

Sequence validation and integrity analysis

Cell Lines

Identification of genomic stability and integration sites

Viral Vectors

Full-genome characterization (of e.g. AAV’s) and contamination screening

Plasmids

Backbone and insert sequence confirmation

Each solution is designed with both regulatory and R&D needs in mind, ensuring the highest level of precision and reproducibility. Monitoring CQAs throughout the lifecycle of these biologics supports regulatory compliance and robust product development.
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What are biologics?

Biologics are complex, cell-derived therapeutic products like recombinant proteins, viral vectors, and mRNA constructs. Their development and production rely on engineered cell lines, plasmids, and vectors, each requiring rigorous quality control to ensure consistency, safety, and efficacy. At OHMX.bio, we provide advanced sequencing-based solutions to support the development and validation of biologics, with a focus on engineered cell lines, viral vectors, and mRNA products.
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Bioinformatics expertise

Alongside advanced sequencing, OHMX.bio provides powerful bioinformatics support. Our tailored pipelines are built to extract meaningful insights from complex datasets, whether for regulatory filing or internal validation. From variant calling to methylation profiling, our team ensures that every analysis meets the highest scientific standards. Our bioinformatics capabilities also focus on identifying and quantifying CQAs in a reliable and reproducible manner.

Partner with OHMX.bio

With years of experience in molecular biology, sequencing, and analytical development, OHMX.bio is a trusted partner in biologics quality control. Our commitment to scientific rigor, personalized collaboration, and fast turnaround times ensures that clients receive the highest quality insights, exactly when they need them. Whether you’re seeking GMP-ready sequencing or early-phase analytical support, OHMX.bio is ready to support your QC challenges with confidence and expertise. Let us help you meet the increasing regulatory expectations and effectively monitor the CQAs that matter most to your biologic product.
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Let’s get in touch!

Are you curious about how we can work on your -omics challenges together? Fill out the form below!
Our experts will reply within 2 working days to freely discuss your omics project.

Our publications using discovery and non-clinical biomarker solutions

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