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Biopharma

BaseClear combines advanced genomics, GMP-compliant services, and deep scientific expertise to help biopharma companies develop, characterize, and release products with confidence.

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Advanced Solutions for Faster, Deeper Genomic Insights

Biopharma companies face increasing pressure to accelerate product development while meeting stringent regulatory, quality, and safety requirements. The development and manufacturing of vaccines, biologics, viral vectors, and cell therapies require highly sensitive analytical methods, robust quality control, validated testing workflows, and comprehensive product characterization. BaseClear helps address these challenges by providing advanced genomics, sequencing, dPCR, qPCR, bioinformatics, and GMP-compliant testing services that generate reliable, regulatory-ready data, enabling clients to make informed decisions and bring innovative therapies to market with confidence. 

BaseClear addresses these challenges by combining advanced genomics technologies with deep scientific expertise, regulatory knowledge, and a strong quality culture. Our multidisciplinary team includes experts in molecular biology, microbiology, virology, bioinformatics, sequencing technologies, and GMP-regulated laboratory operations, enabling us to support clients from early development through commercial manufacturing. Through GMP-compliant workflows, validated analytical methods, dedicated project management, and in-house bioinformatics capabilities, we deliver reliable, actionable, and regulatory-ready data tailored to each client’s specific product, process, and development stage. 

Our Biopharma services

GMP Solutions

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

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GMP Assay Development & Validation Services

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

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Sterility Testing

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.

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Mycoplasma Detection (EP 10.1 and GxP Compliant)

BaseClear provides validated PCR-based mycoplasma testing for biologics, viral vectors, vaccines, and cell therapy products to rapidly detect contamination and support GMP compliance. Clients receive a comprehensive GMP-compliant report with quality-controlled results suitable for quality control, manufacturing release, and regulatory submissions.

GMP Compliant
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ISO & GMP-Compliant Bacterial Whole Genome Sequencing

BaseClear provides validated whole genome sequencing of bacterial strains using Illumina technology to support strain characterization, SNP analysis, contamination investigations, and microbial safety assessments. Clients receive quality-controlled sequencing data, bioinformatics results, and an ISO & GMP-compliant report suitable for research, quality assurance, and regulatory applications.

GMP Compliant
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Quantitative Residual Host Cell DNA testing

BaseClear provides highly sensitive residual host cell DNA quantification using digital PCR (dPCR) to support the development and manufacturing of biologics, viral vectors, vaccines, and cell and gene therapies. Clients receive accurate, absolute quantification results and a comprehensive GMP-compliant report suitable for process monitoring, batch release testing, and regulatory submissions.

GMP Compliant
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Adventitious Virus Testing

BaseClear uses next-generation sequencing (NGS) to screen for known and unknown DNA and RNA viral contaminants in biologics, viral vectors, vaccines, and cell therapy products. Clients receive a comprehensive viral safety assessment, including sequencing results, expert interpretation, and regulatory-ready reports to support risk assessment and product development.

GMP Compliant
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(GMP-Compliant) Phage DNA Sequencing

A flexible, end-to-end phage DNA sequencing service combining advanced NGS technology with phase-appropriate or full GMP compliance. Designed to support phage therapy development, it delivers reliable identity and purity data alongside validated workflows and documentation suitable for regulatory use.

GMP Compliant
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Cell Line and Cell Bank Characterization Using Whole Genome Sequencing

Characterize transgenic cell lines and cell banks with whole genome sequencing to verify genetic modifications, map integration sites, assess genetic stability, and identify genomic variants using state-of-the-art long-read and short-read sequencing technologies.

GMP Compliant
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Custom qPCR assay development for complex biological matrices

BaseClear develops and optimizes client-specific qPCR assays for challenging matrices in regulated and research environments, from cell & gene therapy to microbial and industrial applications.

GMP Compliant
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GMP Cell Line Species Identification via COI Sequencing

Confirm the species origin of your cell lines using mitochondrial COI gene sequencing and validated DNA analysis workflows suitable for research and regulated biopharmaceutical environments.

GMP Compliant
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Microbial identification using Maldi-TOF Vitek MS

BaseClear provides microbial identification services using Maldi-TOF MS (Matrix Assisted Laser Desorption Ionization Time of Flight), a rapid protein based identification technology for bacteria and yeast. This method generates a characteristic mass spectrum of abundant cellular proteins, which acts as a molecular fingerprint for each microorganism. 

GMP Compliant
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Microbial identification using MicroSEQ® Sequencing

BaseClear provides microbial identification services using the MicroSEQ® system, a fully validated platform for DNA based identification of bacteria and fungi. By combining targeted PCR amplification with Sanger sequencing and curated reference databases, this service delivers highly reliable species level identification. The workflow is standardized end-to-end, ensuring reproducibility and consistent data quality across projects.

GMP Compliant
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Project Sequencing GMP (Sanger sequencing services)

BaseClear offers a comprehensive range of Sanger sequencing services, covering both high-end GMP-compliant project sequencing and fast, cost efficient single run sequencing. Sander sequencing remains the gold standard for accurate DNA sequence determination, delivering high quality, long-read data for a wide range of applications.

GMP Compliant
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Viral Variant Detection Analysis GMP Compliant

BaseClear’s service provides accurate detection and characterization of viral genomic variants through validated whole genome sequencing and bioinformatics workflows, enabling researchers and developers to monitor viral populations and assess genomic stability with confidence.

GMP Compliant
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A Reliable Partner

GMP-Ready Genomics Expertise 

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.

From Characterization to Release 

We support the complete product lifecycle of vaccines, viral vectors, and biologics with services ranging from product characterization and contaminant testing to qPCR and dPCR-based quality control, validation, and release support. Clients benefit from a single scientific partner across multiple development and manufacturing stages.

Tailored Validation Support 

Beyond standard testing services, BaseClear develops client-specific validation strategies and analytical workflows aligned with product, process, and regulatory requirements. Our experts work closely with clients to ensure methods are fit-for-purpose, robust, and inspection-ready. 

Science-Driven Project Partnership 

Our multidisciplinary team combines expertise in molecular biology, virology, microbiology, bioinformatics, sequencing technologies, qPCR, dPCR, and GMP laboratory operations. Supported by dedicated project management and direct access to scientific experts, clients receive responsive guidance and solutions tailored to complex biopharmaceutical challenges. 

Proven expertise in Biopharma genomics 

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Ready to accelerate your biopharma pipeline?

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