GMP/GLP qPCR services

Avance Biosciences’  cGMP/GLP qPCR services are offered in accordance with current Good Manufacturing Practices (cGMP), US FDA 21 CFR Part 211, and Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies, US FDA 21 CFR Part 58, and regulatory requirements promulgated by European, Japan, Australia, and other regulatory agencies, as applicable to the services provided.

Applications

Our cGMP/GLP qPCR services are established to support the identity and safety test of cGMP biologics, the analysis of preclinical and clinical trial samples, and the validation of DNA-based tests and devices for Premarket Approval (PMA) or 510K clearances.
Application Description
Copy Number Analysis by qPCR
As part of the cGMP/GLP cell bank characterization services package, Copy Number Analysis by qPCR determines the average copy number of a plasmid or integrated expression contruct in a cell bank. Used for genetic stability tests in biologics manufacturing.
Residual DNA Analysis by qPCR Sensitive and target-specific qPCR assays are routinely used at Avance Biosciences to detect residual host cell DNA in biological products derived from cell substrates (E. Coli, CHO, Yeast, Human, etc). Residual DNA Testings is also commonly used for cleaning validation.
Biodistribution study by QPCR Sensitive and target-specific qPCR assays can be custom designed and validated to assess the presence/absence of gene therapy vectors in tissues collected in a preclinical animal safety study.
Gene expression analysis The expression levels of specific genes, Small RNA, Micro RNA, and any RNA species of different samples are analyzed using Relative Quantitation Assays predesigned by Applied Biosystems Inc. or custom designed.
SNP Genotyping by Real-time qPCR Avance Biosciences assesses single-nucleotide polymorphisms (SNPs)  by conducting allelic discrimination assays with TaqMan® probes. Assays may be predesigned by Applied Biosystems Inc. or custom designed using ABI’s SNP Genotyping Assay Design Software.
Adventitious Agent Testing The presence/absence of adventitious agents, such as virus and bacteria, is determined with Plus/Minus assays that include target specific PCR primers and probes.
Custom Assay Design and Validation Target specific assays of any species are routinely designed, qualified or validated at Avance Biosciences.

Compliance

Our quality system is well designed and maintained to meet the most stringent requirements from regulatory authorities worldwide.  This system is well tested in many on-site client quality audits and is highly accommodated by our customers.

  • cGMP compliance per FDA 21 CFR Part 210/211
  • GLP compliance per FDA 21 CFR Part 58
  • 21 CFR Part 11 compliance
  • Methods/assays validated per ICH guidelines
  • Regularly equipment maintenance and calibrations.
  • Routine internal quality audits and in-process audits
  • Documented change control and review program
  • Incident report, OOS, and CAPA program
  • Vendor assessment program and raw material quarantine and release program
  • Optimized laboratory design and rigorous cross-contamination prevention measures
  • Ongoing employee training and proficiency test program
  • Complete documentation of laboratory procedures
  • Project archive and storage procedures

Experience

Our experienced technical and quality staff have worked together for more than a decade offering GLP/GMP level genomic services for regulatory submissions.

  • Experienced with GLP/GMP project management
  • Experienced with international clients
  • Experience with all major pharmaceutical companies
  • Strong technology and assay transfer capability
  • Assay and project reports readily accepted by regulatory authorities
  • Facility frequently audited by clients

When you partner with Avance Biosciences, we give you undivided attention, share our experience and knowledge, and respond to your needs in a timely manner. Contact our technical staff to discuss your next GLP/GMP qPCR project!

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TaqMan® is a registered trademark of Roche.