CGT Bioanalysis
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.
Capabilities
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
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
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)
