Our Services
Quality Control Services
Always close, we are with you all the way on your Quality Control Services journey. Together, making advanced biologics, and tomorrow’s life-transforming therapies.
This is affinity in the making.
Rely on our Regulatory Compliance
& Quality Control Services
We offer comprehensive analytical and microbiological quality control services throughout all Drug Substance and Drug Product development projects.
Our testing laboratory also provides independent QC services, including compendial analysis (European Pharmacopoeia, Ph.Eur., and USP Standards) and microbiological analysis of medicinal products, medical devices, raw materials, and packaging. All Quality Control and contract analysis services are carried out according to our current, audited quality systems.
Regulatory Compliance & Quality Control Expertise
We hold a GMP license from EMA to perform Quality Control of Human Medicinal Products, Veterinary Medicinal Products and Human Investigational Medicinal Products. Our microbiological testing laboratory has also been inspected and approved by the FDA and is listed on the FDA Drug Establishment registration site.
We routinely perform critical QC tests in-house, including sterility, bioburden, and endotoxin tests. Additional tests can be validated for in-house use by our expert team. Stability testing follows ICH guidelines. The scope of analysis services is tailored to customer requirements and agreed upon during project discussions.
Comprehensive QC Analysis
Identity, potency, safety and purity analysis
- Protein analysis
- Potency analysis
- Cell-based assays
- Purity/Impurity analysis
Compendial analysis, Ph.Eur. and USP
Product specific validation of microbiological QC and safety analysis, Ph. Eur. and USP
- Sterility testing
- Bioburden (TAMC/TYMC)
- Endotoxin testing
Other analysis as agreed in customer-specific technical and quality agreements
Available Quality Control Services:
Current and harmonized pharmacopeial methods are used in contract analysis. Specific methods may either be transferred from the customer or developed at 3PBIOVIAN. We also provide expert services, such as consulting services related to contract analysis and third-party GMP audit services.
- Medicinal Products
- Medical Devices
- Active Pharmaceutical Ingredients (APIs)
- Packaging and raw materials
- Excipients
- Microbiological environmental control samples (active air samples, contact samples, settling plates)
- Pharmacopoeial water
- Others, as agreed