Cell and Gene Therapy (CGT)
Bioanalytical services related to Cell and Gene Therapy
The number of cell and gene therapy (CGT) products in development and clinical trials continues to increase exponentially (*). SBH Sciences is committed to support the CGT and made a substantial investment in state-of-the-art instrumentations including fully automatic ELISA workstation, Flow Cytometry, Luminex, ELLA, PegySue and WES (fully automatic Western Blot), and qRT-PCR. Those platforms enable high levels of sensitivity and accuracy.
CGT bioanalytical methods frequently measure an analyte that occurs as a breakdown / downstream product of the original / administered therapeutic. Both CGT and biomarker assays often lack a true reference material and thus, necessitates the testing of the original therapeutic product, the breakdown product and the endogenous proteins.
SBH Sciences’ scientists are assisting our customers in the biotechnology / pharmaceuticals community pursuing the CGT opportunities by conducting the following studies:
- Scale-up and engineered Organoids to express the protein of interest.
- Develop three dimensional [3D] cell culture methods including 3D printing.
- Pharmacokinetics (PK) and Pharmacodynamic (PD) studies by the measurement of biological samples (e.g., serum) pre and post treatment.
Our capabilities include: ELISA-Based assays, Receptor-Based assays, FACS and Automatic Western Blot.
- Immunogenicity - Measurement the presence of neutralizing antibodies (NAb) against the vector of gene therapy (e.g., anti-AAV). As a positive control, we are using purified antibodies, as well as, positive sera from human subjects known to be positive. We are also assisting clients by testing animal samples (e.g., Pig serum).
Please note: Ma et al. (**) summarizes current practices and trends in the bioanalytical industry concerning the design, development, qualification / validation and implementation of bioanalytical methods used to assess exposure as well as immunogenicity for gene therapies.
- The development of cell-based assays to understand Mechanism-of-Action (MoA) and to assist in the drafting and securing the Chemistry, Manufacturing and Controls (CMC) documents which are an essential requirement for the submission of IND application.
- Optimization of T-Cell activation.
Please contact us so we can discuss your specific needs. We will be happy to assist you. Our expertise is your competitive edge!
(**) Ma M, Balasubramanian N, Dodge R and Zhang Y. Challenges and opportunities in bioanalytical support for gene therapy medicinal product development. Bioanalysis. 2017 Sep;9(18):1423-1430. doi: 10.4155/bio-2017-0116.