QC Services as Part of CDMO Programs.
Biovian holds 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.
The most critical QC tests – sterility test, bioburden test and endotoxin test – are routinely performed in-house. Additional QC tests can be validated for in-house use, as Biovian has an expert team with profound knowledge of pharmaceutical method development and validation. Stability testing is conducted under controlled conditions according to ICH guidelines. The focus and extent of the analysis services depend on the customer/project requirements and are specified and agreed upon in discussions with the customer.
Examples of QC analyses:
- Identity, potency, safety and purity analyses
- Protein analyses
- Potency analyses
- Cell-based assays
- Purity/Impurity analyses
- Compendial analyses, Ph.Eur. and USP
- Product specific validation of microbiological QC and safety analyses, Ph. Eur. and USP
- Sterility testing
- Bioburden (TAMC/TYMC)
- Endotoxin testing
- Other analyses as agreed in customer-specific technical and quality agreements.
Stability study capabilities (for Drug Substances, Drug Products and buffers):
- Controlled cabinets for stability studies – Storage conditions according to ICH guidelines -70°C / -20°C / +5°C / +25°C
- Conditions for accelerated stability studies
- Study planning, analytical QC testing and reporting
QC Contract Analysis and Expert Services
Current and harmonized pharmacopoeial methods are used in contract analysis. Specific methods may either be transferred from the customer or developed at Biovian. We also provide expert services, such as consulting services related to contract analysis and third-party GMP audit services.
Quality control services are available for:
- Medicinal Products
- Medical Devices
- Active Pharmaceutical Ingredients (APIs)
- Packaging and raw materials
- Microbiological environmental control samples (active air samples, contact samples, settling plates)
- Pharmacopoeial water
- Others, as agreed