End-to-End Solutions: From Plasmid DNA to Clinical Sample Analysis 

Cell and gene therapy (CGT) offers immense promise for patients with previously untreatable or incurable diseases. At Frontage Laboratories, we have deep knowledge on GxP regulations and expertise in assay development, assay qualification/validation and sample analysis.  We partner with clients to provide high-quality and reliable solutions to support their CGT programs. Our Genomics team is equipped with cutting-edge genomic analysis instruments, and has more than 2 decades of experience supporting clients in the entire CGT workflow, from early discovery, preclinical, clinical research to post-marketing surveillance. 

 Plasmid DNA and nucleic acids 

Plasmid DNA plays a crucial role in CGT by delivering therapeutic genes into target cells, and serves as the essential starting materials for viral vector manufacturing. Frontage Genomics team has state-of-the-art sequencing, PCR and extraction platforms to provide customizable molecular solutions for our clients. 

Services: 

• Molecular biology: plasmid cloning and preparation.  
• DNA and cDNA Library preparation for NGS. 
• ID Plasmid and viral vector using NGS technology. 
• Support Plasmid DNA QC: integrity and contamination detection. 
• Automated high-throughput DNA/RNA extraction for high quality product. 

Cell and gene therapy products 

Equipped with cutting-edge technologies, our team of expert scientists offer crucial support for testing cell and gene therapy products, aiding in drug identity characterization, copy number determination, impurities and safety detection such as residual DNA or replication-competent viruses. With precision and reliability, Frontage ensures the safety and efficacy of clients’ innovative therapeutic products, empowering clients to advance confidently in the field of precision medicine. 

 Preclinical and clinical 

Frontage Genomics team has the capability to utilize various matrices encompassing a broad spectrum of animal models, patient samples, and developmental stages for exploring a diverse array of compounds. Employing a proficient detection system such as qPCR, ddPCR and NGS, enables us to develop highly sensitive and accurate molecular assays to detect your gene of interest in any tissue or fluid across all species. 

Services: 

• Biodistribution: 
  • Determine the distribution profile and copy number of CGT products (virus, gene-modified cells) in target and non-target tissues and cells over time.  
  • Determine transgene expression profile in nonclinical species to assist in construct optimization, dose recommendation etc. 
  • Biodistribution samples: blood, CSF, various tissues 
    
• Replication Competence and Viral Shedding 
  • Robust assay to detect replication-competent viral vectors post-dose. 
  • Monitor vector shedding to mitigate safety and environmental concerns. 
  • Support clinical shedding study design by leveraging data from preclinical shedding studies. 
  • Shedding samples: blood, saliva, tears, feces, urine, nasal secretions 
    
• Gene Editing  
  • Support Nonclinical safety assessment: on- and off-target editing and chromosome abnormalities. 
  • Assess the specificity and efficiency of editing in target and non-target cells. 
  • Determine the functionality of the correct gen product (RNA). 
  • Assess durability of genomic modification. 

Small Molecule Bioanalysis • Mass Spectrometry

Reputation for consistent, high-quality project delivery

Large Molecule Bioanalysis • Biologics & Bioassays

Comprehensive services in support of advanced development programs

Cell and Gene Therapy Services

Optimized Methods for Cell and Gene Therapy Products

Antibody Drug Conjugates

Over the past decade, Frontage has provided extensive support for many ADC drugs bioanalysis targeting a variety of antigens