From Control Cells to Final Batch Release
Our QC support spans the entire manufacturing lifecycle — from starting materials to final product release — ensuring consistency, traceability, and regulatory compliance at every stage.
We assess the quality of
- Starting Materials (Master and Working Cell Banks, Plasmids)
- Raw materials
In order to be used for GMP production
Upstream & In-Process Controls
During manufacturing, we support in-process monitoring to ensure process control and early detection of variability.
This includes:
- Yield monitoring
- Microbial or Viral Contamination control
- Process-related impurity monitoring
Our in-process strategy is designed to protect product quality while maintaining manufacturing efficiency.
Drug Substance (DS) Testing
For Drug Substance, we provide tests of:
- Identity
- Yield
- Potency
- Purity and impurity profiling
- Safety
All testing is performed according to approved specifications and validated/qualified methods.
Drug Product (DP) Release Testing
Our QC team supports full release testing of Drug Product for clinical use, including:
- Appearance and physical tests
- Identity confirmation
- Potency evaluation
- Sterility
- Endotoxin testing
- Viral titer determination
We work closely with QA and the Qualified Person to ensure timely and compliant batch certification.
GMP & GLP Testing
We offer both:
- GLP-compliant analytical support for development activities
- GMP-compliant release testing for clinical batches
Our QC infrastructure ensures clear segregation, full traceability, and complete data lifecycle management.
We support method:
- Transfer
- Qualification
- Validation
- Optimization
All activities are performed under a robust Quality Management System with full documentation and audit readiness.
Stability & Lifecycle Management
Beyond release, we provide:
- Stability study design and execution
- Ongoing stability monitoring
- Trend analysis
- Support for specification updates and lifecycle management
Our integrated approach ensures continuity between development, clinical manufacturing, and future scale-up.
An Integrated Analytical Strategy
By covering the entire journey — from control cells to final release — we:
- Reduce analytical gaps
- Improve data consistency
- Facilitate regulatory interactions
- Streamline technology transfer
- Accelerate clinical timelines
We act not only as a testing laboratory, but as a strategic analytical partner throughout your product lifecycle.
Regulatory & Quality Framework
Our QC operations are integrated within our QA system, ensuring:
- Data integrity compliance (ALCOA+)
- Controlled documentation management
- Change control and deviation handling
- OOS/OOT investigations
- Full inspection readiness
We support regulatory submissions and provide documentation packages aligned with EMA and national authority expectations.
Flexible Support for Your Project
We understand that each development program is unique.
We offer:
- Tailored testing panels
- Cost-efficient analytical strategies
- Scalable QC support aligned with batch size and clinical phase
- Technical consultation to optimize analytical scope