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.
This service provides GMP-compliant phage DNA sequencing using next-generation sequencing (NGS) technologies within a controlled, traceable, and audit-ready framework. The service integrates standardized laboratory workflows, LIMS-based sample and data management, QA-governed documentation, and validated bioinformatics pipelines to ensure consistency, reproducibility, and data integrity. By operating under GMP-aligned conditions, it supports reliable phage identity and purity assessment throughout development and manufacturing.
This service is designed for innovative biotech and pharmaceutical companies developing phage-based therapeutics that are progressing toward clinical and commercial stages. It is ideal for organizations that require sequencing data meeting GMP and regulatory expectations, including teams preparing for IND/CTA filings, scaling manufacturing, or strengthening quality control strategies.
Whether you are transitioning from early research into regulated development or looking to enhance the reliability and traceability of your analytics, this service supports companies aiming for robust, audit-ready data and streamlined regulatory pathways.
Our phage DNA sequencing service is built on a robust and adaptable workflow that ensures reliable, high-quality results. The process combines controlled sample preparation, next-generation sequencing (NGS) on established platforms, and advanced in-house bioinformatics to deliver accurate and reproducible phage characterization data.
Quality and traceability are integrated throughout the workflow, with structured documentation and oversight aligned to phase-appropriate compliance, and the option to operate under full GMP conditions when required.
We take a collaborative approach, working closely with our clients to tailor the methodology to specific project needs, ensuring the right balance between scientific rigor, flexibility, and regulatory readiness at every stage of development.
You receive a comprehensive, high-quality data and documentation package tailored to your development and regulatory needs. This includes detailed sequencing reports with clear interpretation of phage identity and purity, along with access to processed and raw data in standardized, traceable formats.
Depending on project scope, deliverables can also include fully documented workflows, method protocols, and supporting quality documentation aligned with phase-appropriate or GMP requirements.
For more advanced programs, we offer method qualification and full validation in line with ICH Q2(R2), enabling the generated data and documentation to support regulatory submissions. In addition, clients can obtain a fully established, routine-ready method implemented within our production laboratory, ensuring seamless continuation of testing as their development progresses.
Contact us for a free consultation with BaseClear expert team for specific project requirements.
Discuss your project with our expert team to define your sequencing needs, development stage, and regulatory requirements. We provide tailored guidance to ensure the right approach from the start.
Receive a project-specific proposal aligned with your scope, including methodology, compliance level (phase-appropriate or GMP), sample types, and any specific technical or regulatory considerations.
We establish and execute a fit-for-purpose workflow, including method design or evaluation, sequencing, and data analysis. All activities are performed with built-in quality controls, documentation, and client collaboration to ensure reliable and audit-ready results.
You receive a clear, comprehensive data package and report. Where needed, we support routine testing and continuous adaptation of the workflow as your program advances.
The client, who had previously relied on our research‑grade NGS workflow for phage identity and purity assessment, approached us with the request to transition this pipeline into GMP‑compliant execution. As their programs advanced, they required sequencing data generated within a controlled, traceable, and audit‑ready framework to support future regulatory expectations
In response, we strengthened the workflow by introducing LIMS‑based sample and data traceability, QA‑approved documentation, controlled work instructions and more, to ensure consistent and auditable execution. Per client’s request, we also incorporated a client‑specific, fully customized bioinformatics pipeline, developed and maintained under controlled conditions to support reproducible data analysis.
To demonstrate the method’s suitability for use under GMP, we performed a structured qualification/validation study.
Together, these enhancements enabled a more robust, reliable, and GMP‑aligned phage DNA sequencing process tailored to the client’s evolving quality needs. All improvements, from workflow control to the qualified, client‑specific bioinformatics pipeline, were successfully implemented within a three‑month timeframe, ensuring a smooth transition without disrupting the client’s development activities.
Genomics and sequencing projects completed
Years of sequencing and genomics expertise
Validated molecular analysis workflows
Cell culture samples analysed
Most AVT workflows require only a modest amount of material, and the exact volume depends on the sample type and the sequencing depth needed. We discuss these details with you before submission to make sure you provide the right amount, and not more than necessary.
Our NGS‑based AVT method delivers high sensitivity for detecting low‑abundance viral sequences across a wide range of matrices. Sensitivity is driven by optimized extraction, deep sequencing, and stringent bioinformatic filtering, enabling detection levels suitable for regulatory‑aligned viral safety assessments.
The AVT workflow is compatible with a wide range of sample types, including cell banks, viral vectors, raw materials, in-process samples and final drug substances. Its flexible preparation protocols allow it to handle complex matrices such as serum-derived components or high-background biological materials.
Turnaround time depends on sample type and project scope, but most AVT projects follow a defined workflow that includes preparation, sequencing, bioinformatic analysis, and reporting. Timelines are communicated upfront so you know exactly when to expect your results.
Yes. The final report includes sequencing data, identified viral sequences, and expert interpretation, along with all raw and processed data files. This documentation is structured to support regulatory filings and internal risk assessments.
Yes. The final report includes sequencing data, identified viral sequences, and expert interpretation, along with all raw and processed data files. This documentation is structured to support regulatory filings and internal risk assessments.
Speak with our experts to discuss your cell line identification project. We will help you determine the appropriate analysis approach and provide reliable sequencing results to support your research and quality control workflows.
