Analytical Development, Qualification & Validation - QC & QA
Yposkesi is a one-stop shop
Quality is integral to Yposkesi’s management principles. We consistently strive to always provide high quality products and services that achieve industry standards for patient safety and regulatory compliance within the agreed quantities and deadlines. We feel that these are essential in our ambition to become a leading European bio-manufacturer of gene therapies.
Quality is fundamental at every step of the life cycle of our products from innovation and development to production. Everyone at Yposkesi shares responsibility for taking the necessary actions to ensure that our commitments to clients and patients are respected.
Key Elements of Yposkesi’s Quality Policy include:
- Deployment and maintaining a quality culture that aims to develop, manufacture and supply products whose quality and safety are constant and guaranteed.
- Ensuring compliance of our cGMP operations with applicable external regulations and internal quality requirements.
- Ensuring that continuous improvement is part of Yposkesi’s DNA and is promoted by all employees.
Our Analytical Development is Shared Across Two Teams:
- cGMP analysis at the cGMP QC Lab team
- Analytical development and transfer, plus method validation at the Analytical eXpertise Center (CXA)
The cGMP QC team:
- Maintains the environmental monitoring testing program for all the classified areas, for the Highly Purified Water loop and all other utilities. Those programs consist of routine microbiology assays, bioburden testing, endotoxin, TOC, conductivity etc;
- Controls of all incoming raw material up to its release for cGMP manufacturing;
- Performs in-process control and release assays on all manufactured products;
- Runs stability studies;
The testing of your products can be performed internally at the cGMP QC lab or at the labs of qualified subcontractors, depending on the method. Sterility and viral safety are externalized.
Other analytical capabilities available to support your projects consist of bioburden, endotoxin, gel electrophoresis, qPCR, ddPCR, IR detection western blot, ELISA, HPLC, dynamic light scattering, subvisible particle counting (light obscuration or microscopy), and bioassays.
Stability studies performed following ICH guidelines, include accelerated and/or intended long-term storage conditions. Storage conditions available are vapor phase liquid nitrogen (below -135°C); ≤80°C; -20°C; +2 to +8°C and +15°C to +25°C.
The Analytical eXpertise Center (CXA):
- Centralizes all incoming methods, requests or method assessment;
- Assesses all analytical methods related to a project (method development, transfer, qualification, validation, internal or external assay, etc.);
- Manages analytical development, transfer and validation according to recipient lab needs;
- Ensures that methods used are fit for purpose and scientifically sound;
- Supports all analytical method trouble-shooting
Test methods are qualified or validated according to product development phase and ICH Q2R1 requirements. As a minimum, the qualification assesses specificity, linearity, matrix interference, accuracy, and precision as applicable.