BaseClear supports biopharma companies with GMP-compliant genomics and quality testing services for microbial, viral, and mammalian cell-based products and processes. Our services help clients ensure product safety, identity, purity, and regulatory compliance through solutions such as contamination testing, viral safety testing, mycoplasma detection, sequencing, and cell line characterization. By combining scientific expertise with fast, reliable execution, we help accelerate development while reducing quality and regulatory risk.
BaseClear supports food, feed, and additive companies with genomics, microbial characterization, quality testing, and regulatory support services. We help customers verify strain identity, detect contamination, substantiate product claims, and meet increasingly strict quality and regulatory requirements. By combining advanced sequencing technologies with deep microbial expertise, BaseClear helps clients improve product safety, consistency, and market readiness.
BaseClear combines GMP-compliant laboratory workflows, advanced genomics technologies, and dedicated scientific support to deliver reliable, regulatory-ready data for biopharmaceutical applications.
Customer-requested, custom assay development and validation with a systematic, science- and risk-based approach to developing analytical methods that are fit for purpose and robust across the product lifecycle (Analytical Quality by Design; AQbD) in a GMP-environment
We perform comprehensive sterility testing according to applicable regulatory standards to verify the absence of contaminating microorganisms in clean rooms, pharmaceutical products, biologics, medical devices, and other sterile materials.
Microbial Safety Assessment & Regulatory Services help food, feed, and ingredient companies generate the scientific evidence required to demonstrate the safety of microbial strains, products, and ingredients. This service cluster is designed for organizations seeking regulatory approval, supporting applications such as EFSA, FDA, Novel Foods, feed additives, probiotics, postbiotics, and microbial-based ingredients through integrated testing, genomics, and regulatory expertise.
Microbiome Research services help organizations understand the composition, function, and biological impact of microbial communities across clinical, consumer health, food, feed, and environmental applications. This service cluster is designed for biotechnology companies, food and ingredient developers, pharmaceutical organizations, and academic researchers seeking actionable insights through microbiome sequencing, bioinformatics, and advanced data analysis.
Strain Discovery services help organizations identify, isolate, and characterize novel microorganisms with valuable functional properties for food, feed, biotechnology, agricultural, and pharmaceutical applications. This service cluster is designed for companies and researchers seeking proprietary microbial strains, supported by advanced culturomics, genome sequencing, genome mining, and functional characterization.
GMP projects over the past 5 years
EFSA projects in the past 2 years
GMP audits in the past 3 years
BaseClear is a genomics and quality solutions partner based in Leiden, the Netherlands, serving the biopharma, biotech, food, feed, and life sciences industries. We specialize in microbial, viral, and mammalian cell analysis, combining advanced sequencing technologies, dPCR, bioinformatics, and GMP-compliant quality testing to support both research and regulated environments.
What sets BaseClear apart is the combination of scientific expertise, in-house bioinformatics, regulatory understanding, and fast, reliable execution. From contamination testing, strain verification, and dPCR quantification to viral safety testing and sequencing workflows, we help customers generate high-quality data, reduce risk, and accelerate product development and release. Our ISO 17025 and ISO 27001 certifications, together with our GMP license, reflect our commitment to quality, data security, and regulatory compliance.
BaseClear is known for its customer-centric and highly personalized approach. Clients work directly with dedicated project managers and scientific experts, ensuring clear communication, fast support, and tailored solutions throughout every project. Whether it is coordinating complex studies, arranging sample pick-up, or providing hands-on guidance, our team is always accessible and focused on making collaboration easy and efficient.
Our clients range from emerging biotech companies to global biopharma, food, feed, and ingredient manufacturers, as well as academic and research organizations. They rely on BaseClear as a trusted partner for genomics, quality control, regulatory support, and complex analytical challenges.
We have been using BaseClear service for biomarker analysis related to a clinical trial, where we tested a probiotic product in pregnant females and infant children.
These included microbiome analysis by sequencing and qPCR analysis, cytokine analysis and metabolomics, on a large variety of samples. We furthermore received bioinformatics reports from BaseClear.
Due to the timely and high-quality service delivered by BaseClear, we were able to conduct a clinical trial, that was conclusive as well as successful. We highly appreciate the collaboration with BaseClear. Thank you, BaseClear!
We discuss the study design together. BaseClear thinks along with us how our research questions can be answered, and which analysis techniques are the most appropriate ones in each case.
We appreciate that BaseClear offers a tailored approach, where its staff members are always alert to new aspects and developments that should be considered. It is really important to do this at the study design stage.
We have implemented the MicroSEQ® system within Teva whereby we commissioned BaseClear as back up and expert laboratory. This means that we can use their services if we need extra capacity or a more extensive identification method in the event MicroSEQ® does not satisfy the requirements.
Since we are GMP certified, I first had to perform an audit at BaseClear. We were really quite impressed by what we saw. Everything was meticulously organised. The entire workflow was well documented. We were able to check all the controls and trace them easily in the computer. BaseClear more than qualified for us to be able to outsource materials to them.
For our vaccine production it is important to check for microbiological contamination and to subsequent identify these on the basis of its DNA. BaseClear does excellent work and always sticks to the agreements made.
They also deliver additional services. If for example, an alignment has to be made between a number of specific microorganisms that have already been analysed before. I always receive a response within an hour.
Schedule a free consultation with our experts to discuss your testing needs and regulatory requirements. We’ll help design a compliant testing workflow for your project.
TurboSeq is BaseClear’s accelerated next-generation sequencing service designed for projects where turnaround time directly impacts development decisions, validation timelines, and project milestones. Powered by proven Illumina NextSeq technology and optimized laboratory workflows, TurboSeq delivers high-quality, decision-ready sequencing data in as little as one week from sample receipt without compromising data quality or scientific rigor. The service is particularly suited for sensitive detection studies, residual DNA and contamination analysis, validation and verification workflows, custom assay development, and projects with limited internal sequencing capacity. Clients receive quality-controlled sequencing data, expert scientific support, and a reliable fast-track service that helps reduce bottlenecks, accelerate decision-making, and keep critical programs on schedule.
Hybrid Sequencing combines the strengths of Illumina short-read and Oxford Nanopore long-read sequencing to deliver a more complete and accurate view of complex biological samples. By sequencing the same DNA sample on both platforms, BaseClear generates highly reliable quantitative data alongside enhanced taxonomic resolution, improved genome reconstruction, and deeper biological insights that cannot always be achieved with a single sequencing technology. This approach is particularly valuable for microbiome studies, microbial genomics, strain tracking, and other applications where both accuracy and genomic context are critical. Clients receive integrated sequencing results, comprehensive quality control reporting, advanced bioinformatics analyses, and actionable insights that support confident interpretation of complex genomic and microbiome datasets.
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