Analytical Services for Drug Manufacturing
Analytical services in pharmaceutical API manufacturing are a critical component of the comprehensive suite of services offered during development and manufacturing of a drug substance by a CDMO.
Characterization
- Absolute Configuration
- Solubility Profile
- Salt Screening
- Polymorphism
- Particle Sizing
- Impurity Profiling
- Solid State Characterization
- Drug Product Characterization
Control
- Method development
- Reference Standards
- Impurity Tracking
- Method Verification
- Specification Development
- Specification Justification
- Method Validation
- Raw Material Release
- In-Process-Control
- API
- Release Analysis
- Method Transfer
Stability studies
- Stress Stability
- Drug Substance Stability
- Drug Product Stability
- Degradation Profiling
- Intermediate and storage stability
Process Development and Scale-up Services
At CARBOGEN AMCIS, we offer process development and scale-up capabilities, drawing on over 40 years of pioneering experience in process research and development.
Demonstrating our deep commitment to scientific excellence and pharmaceutical excellence, our dedicated team of more than 100 professionals, approximately half of whom hold a Ph.D., advances more than 150 development projects annually. Our services are designed to cover the full spectrum of process development and scale-up for chemical processes, ensuring not only regulatory compliance but also the highest standards of safety and quality.
GMP API Manufacturing Services
CARBOGEN AMCIS provides GMP API manufacturing services, expertly supporting pharmaceutical projects from clinical phases through to commercialization.
Our services emphasize seamless technology transfer and accommodate production scales from small quantities in grams to large volumes in tons. We utilize GMP-compliant equipment ranging from a few liters to 6300 L. Our robust Business Continuity Plan strategy ensures a secure supply chain across multi-site operations in different geographical zones, guaranteeing security of supply with a long-term production plan.
Full Regulatory Affairs Support
By combining knowledge, accuracy, and regulatory understanding, CARBOGEN AMCIS sets the benchmark for clinical API development and manufacturing services.
We recognize the importance of flexibility and precision in these later stages of clinical development. Our approach ensures close collaboration with our clients and adapts to our client’s needs. This early engagement allows us to align our process management with appropriate risk and cost to the client’s advantage.
Our services comply with ICH Q7 (Active Pharmaceutical Ingredients), Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System) and Q11 (Development and Manufacture of Drug Substances), as well as the latest FDA guidance on lifecycle validation. CARBOGEN AMCIS excels in delivering state-of-the-art late-phase documentation through close collaboration with our operations departments and our clients. This joint approach reinforces a strong regulatory submission strategy and lays the foundation for quality and regulatory compliance over the lifetime.
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