BioPharmaGenomic and Molecular Services
MOgene provides custom testing to support clients throughout their biological product development cycle, from discovery through pre-clinical and clinical studies. We start with your testing goals in mind, then offer flexible, adaptable, and development options that are tailored to your specific needs.
Biologics Discovery Testing
- Complete cycle of services including Feasibility, Method Development, Qualification, and Validation
- Product characterization, Stability & QC testing of API, in-process and finished products
- Stability and integrity check of your insertion sequence
- Allelic discrimination assays
Viral Seed and Shedding Testing
- Virus shedding and transmission assessment of viral vectors for gene therapy products
- Extensive characterization of the MVS including its sequence and analysis of viral subpopulations
- Customized assays for detection and quantitation of virus in clinical samples
- Sequencing and genetic stability of viral and vaccine stocks
- Release testing for clinical trial material and commercial product
Cell Line Development & Cell Bank Testing
- Determination of transgene copy number to measure stability in cell lines used in recombinant protein production
- High throughput nucleic acid extraction and aliquoting pipeline for biobanking purposes
- Full genome sequencing, cell identification (STR), genetic drift studies
- Characterization of novel cell lines used in production process
- Quantitation of contaminating host cell DNA
Adventitious Agent Testing
- Biologics safety testing: ensure cell banks, virus banks, raw materials of animal origin, bulk harvest, and clinical batches are free of bacteria, fungi, yeasts, mycoplasma, adventitious viruses, and any other potential contaminants
Identification of pathogens from samples (using NGS or qPCR) such as: vaccine and virus stocks, eukaryote cell banks, prokaryote cell banks, API and raw material, investigational materials
MOgene leads in gene expression, translation, and utilizes genotyping technology to accelerate pharmaceutical breakthroughs. We have years of expertise in advancing your gene and cell therapy research utilizing precision technology and custom-built quantitation methods.
Biodistribution DNA Testing
- Custom-designed real-time PCR assays for assessing the safety and efficacy of nucleic acid therapeutics
- Biodistribution analysis by qPCR to assess the viral copy number or target sequence in various tissues
- Qualification assays prior to quantitation to assess article interference with assay performance
- Detection or quantification of DNA or RNA viruses in cell banks and bulk harvest material
- Viral vaccine efficacy and viral clearance infectivity studies
CAR-T and Other Cell Therapy Testing
MOgene offers services to support your chimeric antigen receptor-redirected T cells (CAR-T) therapy studies.
- Preclinical Biodistribution Studies: MOgene offers GLP compliant qPCR, ddPCR™, and NGS amplicon sequencing services to accurately assess the quantity of therapeutic cells for biodistribution studies
- Copy Number for Manufactured CAR-T Cells: MOgene can help design and validate your qPCR copy number assays and analysis projects
- Replication Competent Lentivirus Assay for CAR-T Cells: Fast turn-around replication competent lentivirus testing services using qPCR and ddPCR™ methods
- Integration Site Analysis: We utilize a combination of technologies to delineate and validate potential insertion junctions and locations in the host genome
CRISPR-Edited Gene Testing
- Whole-genome sequencing (WGS) to discover off-target sites for cell-based assays (in live or fixed cells) as well as in vitro assays
- Screen cell populations after CRISPR modification to determine the gene-regulatory impact of multiple genes
- Functional analysis of genome edits by RNA sequencing, Methylation sequencing, or ChiP-sequencing
- Sequencing of the plasmids for rapid and high-confidence verification of the CRISPR delivery vectors
- Analyze gene expression via interference (CRISPRi) or activation (CRISPRa)
- Achieve a better understanding of your gene editing biological systems
- Confirm CRISPR-induced knockouts
Clinical Trial Genomic Services
MOgene offers gene expression services ranging from single target to whole transcriptomic analysis, quantitative PCR, Next Generation Sequencing, microarrays, custom assay design, validation, and transfer for clinical trial support studies.
- Determine the genetic stability of recombinant products and characterization of plasmid products by copy number determination and plasmid sequencing
- Targeted gene sequencing panels for various therapeutic applications
- Microarrays for gene expression and genotyping
- SNP genotyping
MOgene has the expertise to perform and validate diagnostic assays to deliver raw and interpreted data for input into your bioinformatic systems. We will work with you on your choice of platform and application to launch your panel.
- Partner with us for the development of NGS validation assay for your clinical bioinformatics software
- Highly trained scientific team and board-certified Medical Director to support, review, and sign-off clinical reports
Laboratory Developed Tests (LDTs)
We support continued development of personalized medicine by assisting with a range of LDTs.
- Customized assay development for detection of DNA variations to help diagnose a genetic disease
- Full-service package from feasibility assays to validation, and sample management to report generation for your LDTs
- Pathogen detection and quantification
- Genotyping and SNP detection
Quality and safety
The Quality Commitment From MOgene
MOgene has an established reputation of complying with relevant national and international quality compliance regulations.
- Audit ready for clients with routine internal quality audits
- GLP compliance per FDA 21 CFR Part 58 and Part 11
- Active CAPA program for process improvement
- CLIA Certification
Quality Management System
MOgene has a robust Quality Management System (QMS) detailed in a manual that ensures compliance for quality monitoring and improvement.
- Transparent and routine communications on project timelines and deliverables
- Complete documentation of standard operating procedures (SOPs) and 100% QC of data
- Rigorous sample management process
Our Biosafety practices enable us to provide services for early R&D and market release studies for pathogens that require BSL-2+ facilities.
- Higher levels of lab safety for antimicrobial, human and animal health vaccine development
- Dedicated BSL-2+ Lab and pre-amplification room for your clinical studies
- Trained personnel to handle BSL-2+ level agents
- UNIDIRECTIONAL workflow
Security and Data Protection
MOgene considers safety and confidentiality a top priority for our client’s data.
- 24/7/365 temperature and humidity monitoring
- Individually coded key access to labs
- Secured access to data records
- Daily back-up of data