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Clinical API Services and Supply

Your CDMO from API development
to API manufacturing

Our clinical active pharmaceutical ingredient production services provide pharmaceutical and biopharmaceutical companies with a critical advantage in clinical API drug development and drug substance manufacturing.

  • Clinical API drug development and manufacturing services, offering high expertise, precision, and regulatory insight
  • Full support on analytical method development, method validation and ICH stability studies for API production
  • Versatility in clinical trial API drug development with high potency API manufacturing and handling of cytotoxic compounds
  • Availability of multiple different purification capabilities such as crystallization, chromatography (e.g.Biotage, HPLC, SMB) and ultrafiltration techniques

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.
Our Organization
At CARBOGEN AMCIS, our commitment to excellence in development of control strategies is evident through our wide range of analytical services for drug manufacturing. We have structured our organization into specialized groups to ensure the highest standards of quality and precision on every project. Our Project-Related Analytical Development Group develops analytical strategies. The Reference Standards Group is responsible for the accuracy and reliability of measurement standards. The Method Validation Group is charged with establishing robust protocols of testing. Our Stability Study Group is tasked with testing the longevity and reliability of drug substances and products — and our Quality Control Group imposes stringent quality control throughout the manufacturing process.
Our Services
We offer complete analytical API development support, including advanced characterization services such as absolute configuration, solubility profiling, salt screening, polymorphism, particle sizing, and impurity profiling. Our control services extend to method development, reference standards, impurity tracking, and thorough method verification. With a focus on specification development and justification, method validation, raw material release, in-process control, API, and release analysis, we provide careful oversight at every stage. Our stability studies, which include stress stability, API stability, drug product stability, and degradation profiling, are designed to confirm product integrity over time.


  • Absolute Configuration
  • Solubility Profile
  • Salt Screening
  • Polymorphism
  • Particle Sizing
  • Impurity Profiling
  • Solid State Characterization
  • Drug Product Characterization


  • 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.

Our strong expertise in GMP manufacturing
CARBOGEN AMCIS has developed strong expertise in GMP manufacturing. This includes the handling chemically highly potent active ingredients and cytotoxic substances, exceptional capabilities in chromatographic separations, including up to 40 cm columns and a leadership in bioconjugation development. Advanced crystallization and polymorph studies, comprehensive salt screening and intense safety assessment of critical reaction steps, even under containment, form an integrated part of our extensive API drug development services.
Our data-driven approach towards process development
Our data-driven approach towards process development includes the quantification of risks starting in the early phases of a project. In preparation of process validation campaigns, the criticality concept supports implementation of robust control strategies as part of Quality Risk Assessments and Proven Accepable Range (PAR) studies, based on the complete extent of data available. To achieve these results, we fully incorporate quality risk analysis and genotoxic impurities evaluation, which confirm that safety and efficacy are our overriding concern.

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.

More than
of experience in Process Research and Development
Percentage of PHDs
within PR&D Department
working in PR&D
More than
development projects
per year

For more information
download our Company
Profile brochure