CGT Bioanalysis

A person wearing a lab coat, face mask, safety glasses, and blue gloves operates a touchscreen panel on a large, white machine in a clean, bright laboratory setting focused on bioanalytical development.

Cell and Gene Therapy (CGT) Bioanalytical Services

Efficient and effective development of assays to characterize CGT products is critical for a CGT R&D program. At Pharmaron, over the past decade, we have established a team that is highly experienced in designing, developing and validating assays to identify and quantify analytes at gene and protein levels, including analysis of viral vectors for gene products. Our CGT bioanalytical service offerings encompass the needs in discovery, preclinical and clinical phases, which can also meet ICH/FDA/EMA/NMPA regulatory IND and BLA/MAA submission requirements.

Close-up of a QuantStudio 7 Flex real-time PCR machine with its illuminated status indicator visible. The background shows an out-of-focus computer monitor displaying data, hinting at bioanalytical development in a laboratory setting.

Discovery CGT Bioanalysis

  • Services:
    • Assay design
    • Method development and qualification
  • Assay type: Quantifying DNA/RNA, therapeutic protein expression and activity analysis  
  • Matrix type: Cells, tissues 
  • Analytical platforms: qPCR, digital PCR, ELISA, Western-Blot, high-throughput imaging
  • Analytes: Viral DNA/RNA (including various serotypes of AAV, adenoviral, lentiviral vectors, etc.), ex vivo modified cells, plasmid DNA, RNA, therapeutic proteins translated from CGT products
  • Areas of applications: PK, immunogenicity, biodistribution, cellular biology
A pair of gloved hands is inserting a cartridge labeled "xMAP Technology" by Luminex into a piece of equipment. The cartridge, with multiple chambers labeled with different test names, demonstrates its use in laboratory diagnostics and preclinical ADME studies.

Preclinical CGT Bioanalysis

  • Services: Assay design, method development, optimization, validation and sample analysis
  • Assay type: Quantifying DNA/RNA, therapeutic protein expression and activity analysis, humoral and cell-based immune response
  • Matrix type: Cells, tissues, blood, serum, shedding samples (e.g. urine, feces, saliva)
  • Analytical platforms: qPCR, digital PCR, ELISA, LC-MS/MS, Western-Blot, Luminex, MSD
  • Analytes: Oligonucleotides, siRNAs/miRNA, DNA & mRNA vaccines, immune therapy cellular products, stem cell products, gene therapy products, viral vectors (serotypes of AAV, adenoviral, lentiviral vectors)
  • Areas of applications: PK/TK study, efficacy study, biodistribution, viral shedding, safety assessment, immunogenicity, dose formulation analysis
Scientists in protective gear, including face masks and blue gloves, use pipettes to transfer liquid samples into test tubes in a laboratory conducting preclinical ADME studies. Several boxes and containers are on the table, with blurred figures and lab equipment in the background.

Clinical CGT Bioanalysis

  • Services: Assay design, method development and validation and sample analysis
  • Assay type: Quantifying DNA/RNA, therapeutic protein expression and activity analysis, humoral and cell based immune response, biomarker analysis
  • Matrix type: blood, serum, saliva, feces, urine, buccal swabs, semen, and nasal secretions
  • Analytical platform: qPCR, digital PCR, ELISA, LC-MS/MS, Western-Blot, Luminex, MSD
  • Analytes: Oligonucleotides, siRNAs/miRNA, DNA and mRNA vaccines, immune therapy cellular products, stem cell products, gene therapy products, non-viral vectors, viral vectors including various serotypes of AAV, adenoviral, lentiviral vectors
  • Areas of application: Biomarker analysis, viral shedding, immunogenicity (screening and post-treatment analysis)