Project Sequencing GMP

From GMP-compliant project sequencing to fast and flexible single-run services, delivering reliable DNA sequence data tailored to your needs.

Flexible and GMP-compliant Sanger sequencing solutions

What is this service?

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

Our services range from fully managed sequencing project, including all steps from nucleic acid preparation to complete sequence assembly, to rapid single run sequencing for routine analysis. This dual approach allows clients to choose between fully outsourced, validated workflows or flexible on demand sequencing options.

Who is it for?

This service is designed for clients in pharmaceutical, biotech, food, and academic sectors who require reliable DNA sequence data. GMP project sequencing is particularly suited for regulated environments, such as pharmaceutical development, where validated workflows, traceability, and documentation are critical.

Single-run sequencing services are ideal for routine applications such as clone verification, plasmid confirmation, PCR product validation and quality control, where speed, flexibility and cost-efficiency are key.

Methodology

Sanger sequencing is based on chain-termination chemistry, generating high-quality DNA sequence reads up to ~1100 base pairs. Fluorescently labeled dideoxynucleotides are incorporated during DNA synthesis, resulting in fragments of varying lengths that are separated by capillary electrophoresis and detected to produce a chromatogram.

For project sequencing, BaseClear provides a fully managed workflow under GMP conditions when required. This includes DNA or RNA isolation, primer design and synthesis, sequencing reactions and primer walking strategies to resolve complete double-stranded sequences. Workflows are validated in accordance with ICH guidelines, ensuring reproducibility, traceability and regulatory compliance.

For single-run sequencing, clients can submit purified DNA or PCR products along with primers (or request primer design). Flexible options are available, including short-read (~550 bp) and long-read (~1100 bp) sequencing, as well as prepaid barcode-based services for high-throughput needs.

What you receive

Clients receive high-quality sequencing data in the form of chromatogram files (.ab1), base called sequences and quality metrics. For project sequencing, deliverables include assembled consensus sequences, full documentation(for GMP projects) and traceability records in line with GMP requirements.

Turnaround times vary depending on the service level. GMP project sequencing is typically completed within 1–2 weeks, while single-run sequencing services deliver results within 1–2 working days.

How it works:
From sample to sequence data

Step 1

Submit your samples

You submit your samples and, if available, reference sequences or primers through our online portal.

Step 2

Project design or run setup

For project sequencing, we set-up the sequencing strategy, including primer design and walking approach. For single-runs, samples are prepared for immediate processing.

Step 3

Sequencing reactions

Sequencing reactions are performed using optimized and automated workflows to generate high-quality DNA fragments.

Step 4

Capillary electrophoresis and detection

DNA fragments are separated and detected, producing chromatograms that represent the DNA sequence.

Step 5

Data analysis and reporting

Raw data are processed into sequence reads, and the results are uploaded to the order portal in the agreed format, including assembled sequences for project-based work.

Proven expertise in validated microbial identification

1 working day
Since 1993

Decades of sequencing expertise

Validated
GMP compliant

Validated workflows

FLEXIBLE
1100 bp

High quality long-read sequencing

TARGETED
24h

Overnight sequencing available

Resources on cell line authentication and species identification

Regulatory Guidelines

European Pharmacopoeia Commission. European Pharmacopoeia, tenth edition Volume 1 194-199 (EDQM, Straatsburg, July 2019)

A guide to EP and global regulatory expectations for mycoplasma testing.
Article

The scope of mycoplasma contamination within the biopharmaceutical industry

Large-scale study evaluating more than 40,000 samples to assess the prevalence of mycoplasma contamination in cell cultures and biological products used in the biopharmaceutical industry.
Article

Prevention and Detection of Mycoplasma Contamination in Cell Culture

Scientific review describing the impact of mycoplasma contamination on cell physiology and metabolism, and outlining best practices for detection, prevention, and elimination in cell culture laboratories.

Frequently Asked Questions

What is the read length of Sanger sequencing?

Sanger sequencing typically produces high-quality reads up to approximately 1100 base pairs. Read length depends on template quality and reaction conditions.

Project sequencing is a fully managed service that includes all steps required to determine complete DNA sequences. This includes sample preparation, primer design, sequencing, and sequence assembly.

Sanger sequencing can be performed under GMP-compliant conditions using validated workflows. This ensures traceability, documentation and regulatory compliance for pharmaceutical applications.

Purified plasmid DNA and PCR products can be submitted for single-run sequencing. Samples must meet the required quality and concentration specifications to ensure optimal performance. Bacterial samples may also be submitted, however they require plasmid extraction, which can be performed by us if needed.

Short read sequencing typically generates reads of around 550 base pairs, while long read sequencing can reach up to 1100 base pairs. Longer reads provide more contiguous sequence information.

Talk to our Scientists

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.

Contact us