Cell and Gene Therapy Final Product Release Testing
As a developer or manufacturer of cell and gene therapies, you must choose a reliable services partner for clinical and commercial success. We share your commitment to a safe and well-characterized product, so partner with us for final product release testing – drawing on our experience to bring your therapy patients. Our team of experts will consult with you to develop a specific testing program, drawing upon an array of available platform assays for final product release. We can help navigate the unique logistic, regulatory, and technical requirements of your advanced therapy with biosafety and characterization testing methods.
- In Vivo Gene Therapy
- Cell Therapy: Autologous and Allogeneic
- BioReliance® Cell Gene Therapy Final Product Release Testing
- Stability Testing and Storage
AAV
Lentiviral vector
Adenoviral vector
For final product release, the identity of the final vector product must be confirmed. This testing may include the sequencing of the gene of interest, infectivity titer, genomic titer, and potency testing. Sterility, mycoplasma, and levels of endotoxin should be analyzed. In addition, characteristics of the final product should be determined, which may include vector aggregation, pH, osmolality, appearance, and particulates.
Immuno-therapies
Stem cell therapies
For final product release, cells for infusion must be analyzed for safety and confirmation of product specific attributes. Safety tests include sterility/bioburden, mycoplasma, and levels of endotoxin. In addition, replication competency testing may be conducted on vector-transduced cells to confirm the absence of replication competent virus. Product specific characterization testing to assess potency, identity, and purity should also be performed as appropriate to support final product release.
Biosafety testing
- Sterility
- Mycoplasma
- Endotoxin (LAL)
- Replication-competent virus
Product-specific characterization
- Identity
- Purity/Residuals
- Potency: expressed protein, function
- Variant and sub-population detection
- Infectious and genomic titer
- Aggregation
- Physico-chemical characteristics
- Capsid protein characterization
We offer custom-designed programs that meet ICH guidelines and help you understand the effects of environmental conditions – temperature, humidity, light, and container interactions – on your therapy. Your stability testing program may encompass:
- Planned storage conditions
- Planned formulation
- Manufacturing holding steps
- Stressed conditions
- Shipping/transport
- Loading into delivery devices
Regulatory and technical services, data review and evaluations, report writing, response to regulatory authorities – we offer all these and more. To contact our experts about your cell and gene therapy product release testing, use our reply form today.
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