Inside every genome is a wealth of therapeutic potential. We will help you conduct the analyses you need to get to the next milestone.
Developing drugs such as biopharmaceuticals, vaccines, and gene therapies often requires a deep dive into the genetic attributes of these products. In order to support drug submissions, it’s essential to quantify genetic biomarkers and define the safety and critical quality attributes (CQA) of these drug candidates.
With extensive expertise in nucleic acid biochemistry, the Custom Biologics Genomics Group is highly skilled and well suited to assist with the transfer, development, validation, and implementation of specific molecular genetic assays to quantify genetic biomarkers and define the safety and critical quality attributes (CQA) of biopharmaceutical, vaccine, and gene therapy drug candidates.
To date, much of the testing we have done falls into three main categories:
- The integrity of genetic material in DNA/RNA based vaccines, oncolytic viruses and gene therapy products can be assessed using q-PCR based amplification technologies.
- qPCR-based quantification of gene expression levels in target cells/tissues following drug treatment.
- Quantification of protein coding mRNAs and non-coding micro and long RNAs in liquid biopsies and formalin fixed paraffin embedded tissues are established and validated to support clinical trials.
- Custom assays for novel genetic markers or established 'off' the shelf assays can be readily implemented to address specific testing needs.
- Validated qPCR-based assays are employed to quantify the residual levels of host cell nucleic acids in bio-pharmaceutical products that have been produced in living organisms.
- The methods and quantitation limits of our host cell nucleic assays comply with the regulatory guidelines of the FDA, the United States Pharmacopeia and the World Health Organization.
- Routine lot release testing is conducted under GMP guidelines.