GMP Services

Navigating the complexities of production strains—such as bacteria, yeasts, phages, and live biotherapeutic products—requires meticulous attention to quality and compliance. At BaseClear, we recognize that a controlled production environment is vital for the manufacturing and batch release of these organisms. Pharmaceutical companies and C(D)MOs must ensure the quality, stability, and safety of their strains in line with Good Manufacturing Practices (GMP). To standardize the production of microorganisms, it is essential to verify strain identification, safety, and stability at every stage. Our sequencing services deliver the precision needed to confirm complete DNA sequences and the integrity of genes or plasmids. The accurate data from our fungal and bacterial identification services supports Quality Assurance and Quality Control in food, water, pharmaceutical, and public health sectors, helping you maintain the highest standards in production. BaseClear has validated the methods within the bacterial whole genome sequencing workflow, according to GMP guidelines. Additionally, BaseClear holds a GMP license for microbial identification.

NGS-based Services

 

Bacterial Whole Genome Sequencing (WGS) offers a complete solution for microbial identification as well as contaminant detection, overcoming the limitations of traditional methods like MicroSEQ and MALDI-TOF. While these methods are useful for strain identification, they may lack the depth needed for whole genome-based insights into strain safety, stability, and antimicrobial resistance (AMR).

BaseClear’s WGS service delivers comprehensive genomic data, including strain identification, variant detection, AMR, stability, and toxicity analysis, supported by a Certificate of Analysis (CoA) under the supervision of a Qualified Person (QP). This approach is vital for rapid microbiological testing, ensuring precise pathogen identification, quality control, and contamination monitoring.

Why Choose BaseClear?

  • More than 30 years of expertise with (production) microorganisms  and bacterial genome analysis – pioneers in adopting new technologies.
  • Fully validated pipelines and a skilled team delivering high-quality, reliable genomic data.
  • Approved GMP supplier to numerous pharmaceutical companies and CDMOs.
  • Audit-ready environment that meets industry standards.
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Sanger sequencing & Microbial identification

Sanger Sequencing: Through our GMP brand, ProBase Pharma, we provide a highly accurate and dependable sequencing service that handles every step required to determine complete double-stranded sequences. Our premium offering, the ‘Project Sequencing’ service, is an all-inclusive package that covers all the steps needed to fully sequence DNA fragments.

Microbial Identification: Identification of bacteria or fungi using molecular methods such as PCR, DNA sequencing and MALDI-TOF

Strain Typing: Characterization of relations between bacterial or fungal strains for in-depth root cause investigation or strain typing.

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