Plasmid Design and Development
At our company, we understand that a robust viral vector process begins with the design and development of high-quality plasmids. Our expert team utilizes state-of-the-art techniques and technologies to engineer plasmids tailored to specific therapeutic gene delivery needs.
Cell Line Development
We offer comprehensive cell line development services, leveraging advanced protocols and automated systems to ensure the generation of stable and high-yield cell lines. Our flexible approach allows us to tailor cell line development strategies to meet the unique requirements of each project.
AAV Process Development
Our company excels in Adeno-Associated Virus (AAV) process development, optimizing scalable suspension-based processes across a range of bioreactor scales. Our in-depth expertise ensures efficient AAV production with high purity and yield, essential for successful gene therapy applications.
GMP Production and Clinical Grade Material Supply
Our seamless transition from feasibility studies to GMP production enables swift and reliable supply of clinical-grade materials. Our company's proven platform processes, coupled with stringent quality control measures, ensure compliance with regulatory standards and product safety.
Analytical and Product Characterization Services
We offer a comprehensive suite of analytical services, including physico-chemical, biophysical, and bioassay technologies. These capabilities enable thorough characterization of viral vectors and associated components, ensuring product quality, stability, and regulatory compliance.
Bioassay Development and Testing
Our company specializes in the development and validation of bioassays crucial for assessing viral vector potency, safety, and efficacy. Our robust bioassay development processes are tailored to meet regulatory requirements and support product development milestones.