GMP Solutions

BaseClear combines GMP-compliant laboratory workflows, advanced genomics technologies, and dedicated scientific support to deliver reliable, regulatory-ready data for biopharmaceutical applications.

Standard validated services and customer specific validations

Biopharmaceutical products such as vaccines, viral vectors, cell therapies, and biologics require rigorous quality control and validated analytical methods to ensure product safety, consistency, and regulatory compliance. BaseClear’s GMP solutions support clients with both standardized validated services and client-specific method development and validation projects, helping organizations meet regulatory expectations while accelerating development and manufacturing timelines. Our expertise covers areas such as microbial and viral safety testing, mycoplasma detection, sequencing, dPCR, qPCR, identity testing, and characterization of complex biological materials.

What makes BaseClear distinctive is our combination of scientific expertise, regulatory understanding, and flexible customer-focused execution. Rather than offering only fixed testing packages, we work closely with clients to develop tailored validation strategies that fit their product, process, and regulatory requirements. Our GMP-licensed laboratory, ISO 17025 accreditation, ISO 27001 certification, in-house bioinformatics expertise, and dedicated project management ensure reliable execution, transparent communication, and high-quality data throughout every stage of the project. 

Services

A Reliable Partner

GMP Ready Genomics

BaseClear combines advanced sequencing, dPCR, qPCR, and bioinformatics services within a GMP-compliant environment. Our GMP license, ISO 17025 accreditation, and ISO 27001 certification help clients meet strict regulatory and quality requirements with confidence.

Full Traceability & Compliance

All GMP workflows are supported by LabWare LIMS and integrated ELN systems, ensuring complete sample traceability, secure data handling, audit-ready documentation, and regulatory compliance throughout the entire project lifecycle. 

Tailored Validation Support

In addition to standardized GMP services, BaseClear develops client-specific validation and testing workflows for vaccines, viral vectors, biologics, and cell-based products. Our scientific experts work closely with clients to create fit-for-purpose solutions aligned with product-specific and regulatory requirements.

Fast Turnaround, Expert Support

Clients benefit from dedicated project management, direct access to scientific experts, and highly automated laboratory workflows that reduce turnaround times and improve consistency. From sample pick-up to final data delivery, BaseClear provides a responsive and personalized customer experience.

Proven expertise

RESEARCH
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GMP

ARTICLES
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ISO 17025

WEBINARS
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Audited since 2022

CASE STUDIES
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GMP Compliant Projects Executed 

Related resources

Frequently Asked Questions

What types of products can BaseClear support with GMP solutions?

BaseClear supports GMP-regulated testing and validation projects for vaccines, viral vectors, biologics, cell therapies, and other advanced biopharmaceutical products. Our services cover product characterization, microbial and viral safety testing, residual DNA analysis, identity testing, sequencing, qPCR, dPCR, and custom validation projects throughout the development and manufacturing lifecycle.

BaseClear develops and validates customer-specific analytical methods tailored to product, process, and regulatory requirements. In addition to standardized GMP services, our scientific team works closely with clients to design fit-for-purpose testing strategies, validation protocols, and analytical workflows that support regulatory submissions and quality control programs.

BaseClear operates GMP-compliant laboratory workflows supported by a GMP license, ISO 17025 accreditation, and ISO 27001 certification. Projects are managed through LabWare LIMS and integrated Electronic Laboratory Notebook (ELN) systems, ensuring complete traceability, secure data handling, audit-ready documentation, and regulatory compliance. 

Sequencing technologies can be successfully applied within GMP-regulated workflows when supported by validated methods, controlled processes, and appropriate documentation.

Working with a single GMP-regulated testing partner improves project efficiency, consistency, and accountability. Because BaseClear combines sequencing, qPCR, dPCR, bioinformatics, validation support, and project management within one organization, clients benefit from streamlined communication, reduced project complexity, faster turnaround times, and a single source of reliable, regulatory-ready data. 

Explore related services

SERVICES

Mycoplasma GMP testing

Detect mycoplasma contamination in cell cultures using sensitive molecular detection methods.

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Sanger Sequencing

High-accuracy DNA sequencing for PCR products, plasmids, and targeted genetic regions.

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Residual host cell DNA quantification

Quantify the residual host cell DNA in your samples using digital PCR technology.

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