Clinical API Development
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CARBOGEN AMCIS has a DNA in API development, stretching back over 30 years. Our API development teams are selected for their passion for science and experience in the application of phase-appropriate efforts to solve challenging chemistry issues.

From taking a promising molecule from our clients' medicinal chemistry team to optimizing a late-phase API in readiness for validation and commercialization, our API development group has the skills, experience and an unmatched set of tools to meet your goals, however challenging they may be.

CARBOGEN AMCIS: Your aspirations enhance our opportunities

The most amazing part of my job is supporting an enterprise that has a direct impact on the well-being of people as well as observing and interacting in two fields: the chemistry between molecules and the chemistry between humans.

Emad - Manager PR&D, Aarau

Analytical Services

The complete integration of analytical sciences into the process of API development is fundamentally understood at CARBOGEN AMCIS. Our scientists, technique ranges, systems (including a fully validated LIMS) and procedures facilitate a full understanding of the unique characteristics of the complex molecules we work on. With a ratio of 2 analysts to 1 chemist we are uniquely placed to address the challenges posed in the development of NCEs for our clients.

Chemistry Expertise

Underpinning all of our core services is our chemistry expertize. We are leaders in the field of complex and difficult chemistry and scale-up. As such, we handle a multitude of disparate chemical reactions, while managing complex supply-chain challenges. We have extensive experience and proficiency in handling all kinds of chemical reactions, reagents and techniques such as:

  • Alkylations / Arylations
  • Amide / Peptide Coupling
  • Esterification / Ester Cleavage
  • Heterocyle Synthesis
  • Hydrogenation / Deuteration
  • Knoevenagel + Decarboxylation
  • Matteson Reactions
  • Nucleosides / Nucleotides
  • Organolithium- / Grignard Couplings
  • Oxidation / Reduction
  • Ozonolysis
  • Pd-Catalyzed Couplings
  • Protecting Group Manipulations
  • Plus all in combination with different potencies of active intermediates & API

Process Development and Scale-up

CARBOGEN AMCIS has more than 30 years of experience in Process Research & Development. Our highly qualified, experienced & motivated staff members, along with their extensive project management experience, provide seamless & personalized communication between cross-functional departments & customers.  This is the foundation for the provision of design & development of new routes for targeted molecules, with integrated QbD support from the outset of each project.  Within our PR&D section there is one Development Chemist to every two Analysts and over 40%of our staff-base in Switzerland have achieved PhDs or greater.

Below you will find just some of the services our PR&D team provides:

  • Process development & scale up of lab procedures to initial kg quantities based on QbD principles
  • Process robustness studies supported by DoE (designs of experiments)
  • Process optimization & cGMP production on large scale
  • Chromatography development & cGMP production (Normal phase, MPLC, HPLC, SMB)
  • Quality Risk Assessments to support process validation & regulatory filing strategies
  • Late-phase / commercialization expertise
  • Crystallization development & polymorph studies for intermediates & API

More than

30

years

of experience in Process Research and Development

Percentage of PHDs

50

%

within PR&D department

Staff

100

+

working in PR&D

More than

150

development projects

per year

For more information
download our Company Profile
brochure or contact us today.