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Raw Material Testing for Gene Therapy Manufacturing

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Raw material testing for gene therapy manufacturing is critical to ensure product safety, efficacy and quality control. It includes comprehensive quality control of starting raw materials, auxiliary materials, production consumables and inner packaging materials, the quality of which directly affects the performance of the final gene therapy product.

CD Formulation is well-versed in evaluating the critical quality attributes (CQA) of a wide range of adjuncts and raw materials used in testing cell and gene therapy products. We offer raw material testing technologies that use proven GMP methodologies, platform technologies, and customized approaches to provide robust, flexible, and high-throughput testing services for gene therapy research.

Importance of Raw Material Testing for Gene Therapy Manufacturing

Facilitate gene therapy product development. Raw material test results can guide product development, help improve and optimize production processes, and enhance product quality.
Ensure production consistency. By controlling the quality of raw materials, we can ensure the consistency and repeatability of the production process, which is important for the production of gene therapy products with complex processes.
Safety assurance. Raw material testing helps to minimize the risk of exogenous contamination in the final gene therapy product to ensure the safety and efficacy of the product.
Sterility and viral safety. Sterility and viral safety testing of raw materials is especially critical for gene therapy products that cannot be ultimately sterilized.

Explore Our Raw Material Testing

Raw material testing needs to consider many factors, such as the source, grade, potential external factors, toxicity, etc. Below we will briefly explain the three aspects of quality control, content determination and production process. The quality control programs usually include identification, content, potency, purity, impurities, and other routine tests. In addition, content determination involves different types of total particle number, genomic titer, infectious titer and transduction titer for viral vector products. During the manufacturing process, we must also perform appropriate tests on raw materials to ensure the sterility of the raw materials.

Our Biologic Raw Material Testing Capabilities

Chemically defined growth media	Amino acid analysis for identification and content. Platform pH, osmolality and appearance. Vitamin and sugar content. Growth promotion and functional assays. Microbiological assays.
Process buffers, cryopreservation solutions and chemical transfection agents	Ion characterization. Platform pH, conductivity, osmolality, FT-IR, specific gravity. Platform protease, RNase and DNase assays, phosphatase, excision activity assays. Titration, HPLC, GC. Cell viability assays. Cell cytotoxicity assays.
*Cytokines, growth factors, enzymes, etc.*	Enzyme activity assays and kinetics. Total protein by UV. Purity, oligomers and aggregates. Microbiology assays. Cell-based potency and functional analysis. Platform pH and osmolality. Residual host cell DNA. Residual host cell proteins.

Highlights of Our Raw Material Testing

We offer a comprehensive range of technical services for testing raw materials in gene therapy manufacturing based on client program needs to support all testing requirements.
In addition to raw material testing utilizing established methods, we can develop and validate unique approaches to testing biological materials.
We provide reliable and accurate testing services with the ability to meet the scrutiny of relevant organizations.
Our experienced and professional research team will provide you with high-quality technical support and effective solutions until the outcome of your project.

Published Data

Technology: The site-specific gene delivery technology

Journal: Biomaterials

IF: 12.4

Published: 2011

The article discusses the creation of a new type of nanometer-sized complex (CDplexes) using a cyclodextrin platform with a polycationic cluster and hydrophobic tails (paCDs) that can bind with plasmid DNA for broad transfection capabilities. The hypothesis is that adding biorecognizable elements to the cyclodextrin's hydrophilic rim would allow the resulting nanoparticles to specifically interact with cell receptors. This was validated by developing a method to create glyco-amphiphilic CDs (pGaCDs) that can self-assemble with DNA into nanoparticles recognized by mannose-specific lectins. These nanoparticles were found to bind specifically to macrophages and facilitate gene delivery in a mannose-dependent manner, suggesting their potential for targeted gene therapy.

CD Formulation relies on an advanced technology platform and a strong research team that can provide reliable technical support for key aspects of gene therapy products. If you are interested in us, please feel free to contact us.

References

Díaz-Moscoso A, et al. Mannosyl-coated nanocomplexes from amphiphilic cyclodextrins and pDNA for site-specific gene delivery. Biomaterials. 2011, 32(29):7263-73.