Commitment to Quality
We understand that quality assurance is key to laying a solid foundation for each therapy in the clinic, and employ an EMA and FDA-compliant Quality Management System to ensure stringent controls.
We emphasize maintaining exceptional quality throughout our viral vector manufacturing facility. To achieve this, Genezen has established a dedicated quality assurance (QA) team that seamlessly integrates into our manufacturing processes. Our technicians receive comprehensive training from our team of quality experts, equipping them with the necessary skills and knowledge to uphold rigorous standards. Operating independently, our QA team reports directly to our CEO, ensuring objectivity and impartiality in their evaluations. This robust QA framework allows us to consistently deliver high-quality viral vector services, adhering to the strictest safety and regulatory guidelines.
Culture and training
- Quality-centric culture
- Ongoing employee training and proficiency tests, including annual Good Manufacturing Practices training
- Independent quality team overseen by C-suite leadership
Robust controls are in place to ensure your products are delivered with the highest quality and safety. Our EMA and FDA-compliant quality management system provides enhanced document management and electronic change control capability which strengthens compliance and decision-making.
Quality Software
- Veeva Quality Suite, including Vault QualityDocs, Vault Training, Veeva LearnGxP and Vault QMS
Quality Controls
- Established and qualified quality control methods including plaque/viral/titer
- Robust Environmental Monitoring Program
- Routine internal and client quality audits
- Supplier Qualification Program
- Raw Material quarantine and release program
- On the Floor Quality ensuring regulatory compliance and adherence to Standard Operating Procedures
The Genezen team is experienced in method development and validation of customized biological assays that are specifically designed to assess and ensure the quality of your products and cater to the unique requirements of different stages in the gene therapy development process. Our Quality Control team can help you manage your viral vector release testing and your ongoing stability programs. Our comprehensive testing services, comprising both novel and compendial assays, include:
- Residual DNA and plasmid DNA
- Residuals by ELISA (HCP, benzonase, BSA, affinity, ligand)
- Capsid purity
- Physical Titer (ddPCR/ELISA)
- Function/potency assays
- FDA Guidance for industry: cGMP for Phase 1 Investigational Products
- 21 CFR Part 58: Good Laboratory Practice
- 21 CFR 210 & 211: cGMP for Finished Pharmaceuticals
- EU Eudralex Volume 4 Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
- EU GMP Annex 1: Manufacture of Sterile Medicinal Products
- ICH Guidelines Q2(R2) Validation of Analytical Procedures
Meet Our People
Meet Our People
Our team is dedicated to getting your viral vector where it needs to go. Communication and collaboration are part of our DNA and we can’t wait to talk to you about your current challenges and needs.
Steve Favaloro
Susan D’Costa, PhD
Steve Favaloro