Viral Vector Process Development
Viral Vector Process Development
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Viral Vector Process Development

Viral Vector Process Development

  • Plasmid Design and Development
  • Cell Line Development
  • AAV Process Development
  • GMP Production and Clinical Grade Material Supply
  • Analytical and Product Characterization Services
  • Bioassay Development and Testing

Viral vectors serve as vehicles for delivering therapeutic genes into target cells, offering immense potential in treating genetic disorders, cancers, and other diseases at their root cause. Viral vector process development stands at the forefront of modern biotechnology, revolutionizing gene therapy and biologics manufacturing. Our company is a renowned name in the material sciences industry with over 20 years of experience, exceling in providing cutting-edge solutions in viral vector process development services.

Our Services

Our company provides a comprehensive range of viral vector process development services including:

Plasmid Design and Development

Cell Line Development

AAV Process Development

GMP Production and Clinical Grade Material Supply

Analytical and Product Characterization Services

Bioassay Development and Testing

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.

Features of Our Services

Scalable Platform and Technologies

Our company boasts an 80,000 ft2 flexible development and manufacturing facility equipped with scalable suspension culture systems and a range of bioreactor scales from 15mL to 500L. These technologies enable us to optimize production processes and scale up seamlessly from research to commercial manufacturing.

Expertise in Viral Vector Production

Our team's expertise spans cell line development, AAV process development, chromatography-based purification, and ultra-centrifugation techniques. We leverage this deep technical knowledge to design and optimize efficient and high-yield viral vector production processes.

Regulatory Compliance and Quality Assurance

Our company adheres rigorously to regulatory standards such as EMA, and MHRA. Our MHRA licensed GMP production suites, coupled with robust Quality Control (QC) measures and authoring CMC sections for regulatory submissions, ensure compliance and product safety throughout the development lifecycle.

As technology evolves, our company remains at the forefront of innovation in viral vector process development. Our ongoing investments in high throughput process development, automation, and single-use technologies reflect our commitment to staying ahead of industry trends and meeting the evolving needs of our clients. Contact us to learn more about how we can support your scientific endeavors and help you achieve your goals.

Trust Us for Your Pharmaceutical Development Needs.

Our company offers a comprehensive range of viral vector process development services to support a wide range of research and development efforts in the pharmaceutical, biotechnology, materials science and chemical industries.

Please kindly note that our products and services are for research use only.