Gene & Cell Therapy Service
Gene and cell therapy play important roles in the treatment of diseases such as ALS, multiple sclerosis, hemophilia, cancer, etc.
Gene therapy
Gene therapy has a particularly profound impact on congenital diseases. Many diseases may involve a genetic component - a missing gene, multiple copies of a gene, or a gene that is structurally defective. Gene therapy is the process of replacing or modifying a gene to correct a defect
Cell therapy
Cell therapy involves replacing or modifying cells to treat a disease. In general, scientists use a person's own cells, genetically modify them in vitro to expand the number of modified cells, and then re-inject these modified cells to produce a therapeutic effect. Cell therapy is personalized such as CAR-T cell therapy
Figure 1. Two-step procedure for developing in vitro potency assays for cell and gene therapy products. (Doucette, K.; Shujat, H. J. 2020)
Our Services
To make it easier and better for researchers, BOC Sciences provides gene & cell therapy service service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs. BOC Sciences can provide high quality process development and manufacturing services for DNA plasmids, viral vectors and cellular therapeutics including cGMP manufacturing assets from state-of-the-art laboratories operated to global regulatory standards
- Microbial cell banking and characterization
- DNA plasmid process development and manufacturing
- Process development, non-GMP and GMP manufacturing of viral vectors (LV, RV and AAV)
- Process development, non-GMP and GMP manufacturing of cellular therapies (CAR-T, TCR-T, CAR-NK, DC and iPSC)
- Filling and finish
- IND application support
Gene therapy research and development
In the early stages of gene therapy development, our team identifies the most reliable analytical methods to provide the data needed to guide effective development decisions. Then, we perform robust evaluations of the physicochemical and biophysical properties of therapeutic molecules, and our services include:
- Determination of molecular weight (DNA / RNA)
- Conformation of the nucleic acid
- Thermal and chemical stability
- Determination of molar extinction coefficient
- Capsid integrity and protein composition
- Composition and size distribution of lipid nanoparticles (LNP)
- Encapsulation efficiency (LNP/VLP)
Cell therapy research and development
BOC Sciences has established chimeric antigen receptor (CAR-T) cell therapy. Our focus is to broaden the impact of cell therapy in oncology by going deeper in B-cell malignancies, and investigate potential next-generation CAR-Ts that focus on new targets
Figure 2. Schematic representation of suicide gene therapy. (Raffaella, G.; Giacomo, O. et al. 2014)
Innovative Assays
a. Cell-based therapy products testing
- Sterile BACT/ALERT and many qPCR assays for rapid turnaround tools to detect contaminants
- Cytogenetics methods for the performance of G-banding karyoping
- FISH (fluorescence in situ hybridization) studies
- Cell therapy products based on human embryonic stem cells (hESC), mesenchymal stem cells (MSC) or induced pluripotent stem cells (iPSC)
b. Gene therapy products detection
- Biosafety characterization of all types of viral vectors including lentivirus, adenovirus and AAV
- qPCR detection of plasmid gene sequences
- Luminescence-based assays for cytotoxicity assessment of CAR-T cells (chimeric antigen receptor T cells)
Figure 3. Cell-gene therapy strategies. (Aguilar, E.; Pulido, M. C. et al. 2014)
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of gene & cell therapy at competitive prices for global customers. Personalized and customized services of gene & cell therapy can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
References
- Doucette, K.; Shujat, H. J. Potency Assays for Cell and Gene Therapy: Absorption Systems describes a step-by-step approach to developing GMP-compliant in vitro potency assays. Genetic engineering & biotechnology news: GEN. 2020. 40(2): 45-47.
- Raffaella, G.; Giacomo, O. et al. Improving the safety of cell therapy with the TK-suicide gene. Front Pharmacol. 2014. 6: 95.
- Aguilar, E.; Pulido, M. C. et al. Gene-modified mesenchymal stromal cells: A VIP experience. Inflammation & Regeneration. 2014. 34(4): 176-183.
