SubscribeCarboGen and AMCIS, recognized as world leaders in the development chemistry market, combine world-class chemistry skills to provide seamless drug substance development and commercialization services.
We offer an array of integrated pharmaceutical services to support faster, safer drug development with improved cost efficiency. This commitment helps our clients make decisions more quickly and progress more candidates through the development pipeline in a shorter period of time.
Our services focus on offering seamless drug substance development ranging from process research and development to the supply and manufacture of active pharmaceutical ingredients (APIs) for clinical and commercial use.
In addition, we offer Centers of Excellence, which include Highly Potent API Supply, Fast-Track Synthesis, Analytical Services and Chromatography Services.
The integration of CarboGen and AMCIS provides our customers access to solutions that fit their needs – whether that means individual drug development services or an entire seamless process, from research through manufacturing.
Services
CarboGen: Process Research and Rapid Supply of APIs
Serving as a bridge between medicinal chemistry and full-scale manufacturing, CarboGen provides process research services with a core competency in the rapid supply of active pharmaceutical ingredients (APIs).
Our API manufacture concentrates on producing supplies necessary to conduct early clinical trials. Typical batch sizes range from 50 g to 50 kg and are prepared to the highest standards of Good Manufacturing Practice (cGMP).
As such, the service is modular and tailored to the individual needs of each client from initial route-finding through cGMP production.
Carbogen Performance
AMCIS: Process Development and cGMP Manufacturing
With core competencies in both process development and Good Manufacturing Practice (cGMP) manufacture of active pharmaceutical ingredients (APIs) for clinical and commercial use, AMCIS is well equipped to rapidly develop and scale-up chemistry in response to customer needs. We manufacture product according to the highest standards of cGMP.
AMCIS offers great depth of experience in a broad range of organic reactions. Our capabilities include a diverse selection of routine chemistries as well as a wide variety of sophisticated modern technologies including low-temperature reactions, metallo-organic reactions, peptide synthesis, chiral synthesis and hydrogenation at elevated pressures.
Communication
Centers of Excellence
CarboGen and AMCIS are committed to meeting your individual needs. We specifically designed our Centers of Excellence to be available as part of our core services or on a stand-alone basis.
Highly Potent API Supply
CarboGen and AMCIS provide the synthesis of highly potent active pharmaceutical ingredients (APIs), such as oncologics, for both clinical trials and commercial use. Our service is supported by a state-of-the-art infrastructure that includes process research and development facilities and a Kilo-scale manufacturing facility designed to operate at or below an OEL of 0.3 g/m3.
This specification allows safe handling of highly potent compounds within Categories I to IV (as defined in the Performance Based Exposure Control Limits for Pharmaceutical Drug Manufacturing).
Chromatography Services
Our Chromatography Services offer flexible and customized solutions for the separation and purification of lead compounds and intermediates.
Our specialized group of chemists dedicated to this practice has cultivated an expertise in method development, feasibility studies and scale-up of chromatographic separations using Medium-Pressure and High-Pressure Liquid Chromatography (MPLC/HPLC) and Simulated Moving Bed Chromatography (SMB), all within a Good Manufacturing Practice (cGMP) environment.
Analytical Services
Our Analytical Chemistry practice provides support for laboratory and production chemistry. Our services range from the release of raw materials to the release of active pharmaceutical ingredients (APIs) – including elucidation of impurities and by-products, validation of analytical methods, stability studies, polymorph-related investigations and the preparation, characterization, storage and distribution of reference substances. Our Laboratory Information Management System (LIMS) ensures efficient integrated data
processing, management and storage.
Fast-Track Synthesis
Fast-Track Synthesis provides the rapid and reliable delivery of small quantities of organic compounds for discovery and development programs. We maintain a simultaneous commitment to speed and quality with a promise to deliver right the first time. Typical projects include the synthesis of lead compounds, intermediates, scaffolds, impurities, degradants, comparison materials and analytical reference standards.