Quality control services
Virus-based QC and analytical testing services
Your Health Authorities submission and project timelines are our key priority.
The Quality Control Department, located in Strasbourg site in France, is our centre of excellence to support your drug substance and drug product.
Our Analytical Specialists are multi-skilled and can:
- Contribute to the design of a robust quality control package
- Help you identify relevant and essential analytical methods for the characterisation of your product and the process-related impurities
- Qualify and validate the analytical methods
Our highly qualified & trained QC team performs quality control and release testing as well as stability studies or project characterisation.
At OXB, we believe that the early definition of the Quality Control strategy as well as the robustness of the analytical methods are often on the critical path of a successfully developed project.
If needed do not hesitate to contact us for a consultation.
ANALYTICAL METHOD TRANSFER
Safety
- Sterility & Endotoxins
- Mycoplasma & Mycobacteria by culture and PCR
- Bioburden Testing
- Endotoxin Testing
- In vitro Adventitious Agents
- Bovine viruses by PCR
ANALYTICAL METHOD DEVELOPMENT
Purity
- Total Protein
- Western Blot Testing
- HPLC Testing
- SDS-PAGE
- Residuals Testing
- HCDNA
- HCP
- Intact Cells
- Mass Photometry
QUALIFICATION
Potency
- Plaque AssayTesting
- TCID50 Testing
- ELISA Testing
- Viral Genome by dPCR
- qPCR Testing
- Protein Functionality
- Viral Particles Enumeration by HPLC
- Biodistribution by PCR
ANALYTICAL VALIDATION
Quality
- Osmolality
- pH/Appearance
- Particulate Matters
- LC/MS
- CCIT
- Extractable Volume
GMP OC RELEASE/ STABILITY TESTING
Identity
- PCR
- Enzyme Restriction Mapping
- NGS
- Cell Identity
- ELLA
Quality and Regulatory Support for Our Cell and Gene Therapy Services
A key priority at Oxford Biomedica is maintaining the highest product quality. Our commitment to quality shows its value through our delivery of quality products to patients.
- Our successful navigation of several regulatory filings is a direct result of quality being a day-to-day imperative that permeates through the whole organisation.
- We work closely with our partners to enable successful regulatory approval.
The experience and expertise that we bring will guide you to ensure a smooth process. We will partner with you to develop strategies to mitigate risk to your programme and ensure constructive relationships with regulatory authorities.
