Advanced Therapies: ATMP Manufacturing and Bioanalysis
Advanced Therapy Medicinal Products (ATMPs) are a novel area of therapeutics that includes many groundbreaking approaches to medical intervention for disease. Bioanalytical testing of ATMPs for safety and efficacy is an evolving field as the body of data on these modalities continues to grow.
Tailored strategies for ATMP bioanalytical support
ATMP is a general term which encompasses a number of discrete therapeutic modalities that are of biological origin including genes, somatic cells, or engineered tissues. These therapeutics can be applied to a wide range of indications from neurologic diseases such as Alzheimers to oncologic diseases such as lymphoma. Common subcategories for these drugs include:
Diverse assay types for ATMP testing
Each of these modalities requires a unique strategy for bioanalytical support. At BioAgilytix, we have made significant investments to our instrumentation and scientific expertise over the years to ensure that we are able to offer high-quality, tailored services to meet these demands. Our molecular capabilities, including ddPCR and qPCR, and our cellular immunogenicity capabilities, including ELISpot and flow cytometry, are key components for a strong bioanalytical testing program for ATMPs. Combined with the more traditional methodologies we offer such as immunoassays and mass spectrometry, BioAgilytix is able to provide customized approaches for a comprehensive service package to support your ATMP bioanalytical needs. Here are a few examples of how we are applying these methodologies to some of our specialized ATMP service offerings:
Cell and CAR Therapies
- Cellular immunogenicity (ELISpot or flow cytometry)
- Cellular kinetics (PCR or flow cytometry)
- Immune phenotyping (flow cytometry)
- Cytokine analysis including cytokine response syndrome monitoring (MSD, luminex)
- Vector and transgene anti-drug antibodies (ELISA, MSD)
- Vector copy number (PCR)
- Viral shedding and distribution (PCR)
- Replication competent virus (PCR)
Global regulatory support for ATMPs
In addition to having experience with a wide range of techniques and methodologies for designing appropriate assays for ATMP studies, BioAgilytix is able to supply the necessary level of regulatory oversight for each assay and each stage of your program. Our global facilities can provide non-regulated or GLP, GCLP, GMP, and CLIA compliant assays. We also maintain a robust assay transfer program in order to perform internal assay transfers in the event that a clinical program has global requirements for bioanalysis. Together, these capabilities ensure that BioAgilytix can provide bioanalytical support for ATMP programs from early phase pre-clinical all the way through approval and post-marketing.
BioAgilytix as an industry leader for ATMPs
As the available body of data continues to expand for these various types of ATMPs, the expectations for assays to support these drug programs evolves also. Global regulatory agencies and international bodies continually modify their expectations in the form of revised procedural advice and guidelines. At BioAgilytix, we work closely with regulatory and industry working groups to ensure that we are always at the forefront of the field, ready to implement new requirements in a seemless and compliant manner when they occur. Our scientific experts actively partner with our clients to ensure successful, on-time delivery of data that is consistent with current regulatory expectations to aide in driving the success of your ATMP therapeutic programs.