Clinical API Development

Clinical API Development
Product Description

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

  • CH
  • 2015
    On CPhI since
  • 1000 - 4999
    Employees
Contract Service

CARBOGEN AMCIS

  • CH
  • 2015
    On CPhI since
  • 1000 - 4999
    Employees
Contract Service

More Products from CARBOGEN AMCIS

  • Commercialization Services

    Product Commercialization Services

    CARBOGEN AMCIS has a track record, extending over 25 years, helping our customers transition their molecules from process development through validation and ultimately into commercial status. A range of services backed up with fully integrated support functions has been developed to facilitate and smooth the path to the commercialization of a compound.
  • Analytical Services

    Product 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.

  • Drug Products

    Product Drug Products

    CARBOGEN AMCIS has developed a comprehensive range of services for the formulation of New Molecular Entities (NMEs) and the reformulation of existing drugs. With a specialization in developing sterile and pyrogen-free parenteral formulations for preclinical and clinical trials (phases I, II and III), CARBOGEN AMCIS is your partner of choice for complex and demanding products, that require the highest levels of quality in our industry.
  • Highly Potent API

    Product Highly Potent API

    CARBOGEN AMCIS has state of the art facilities and controls to handle both drug substance and drug product of the highest potency and toxicity, under cGMP. Our dedicated containment facilities use a containment methodology, utilizing barrier isolation technology and Rapid Transfer Ports (RTPs), combined with pressure cascades, airlocks and access controls. Our service portfolio starts from laboratory-scale (for process research and development purposes) up to large-scale manufacturing, in 1,600 liter vessels. These capabilities are underpinned with dedicated analytical and preparative purification technologies.

  • ADC and Bioconjugation

    Product ADC and Bioconjugation

    As pioneers in the highly potent landscape for over 14 years, CARBOGEN AMCIS has successfully delivered a significant number of drug-linker projects. Our first Antibody Drug Conjugates (ADC) project was delivered in 2005. Since then, our customers, ranging from small biotech to large pharmaceutical companies, have taken full advantage of our ADC and bioconjugation capabilities. Our state-of-the-art bioconjugation facility, staffed with a dedicated team of experts, has been in operation for several years and can support you in conceptualizing and delivering the best linker and conjugation strategy. Our ADC suite is directly supported by both our small molecule development capabilities and our formulation expertise that provide an end-to-end solution, in order to rapidly progress your New Chemical Entities (NCE) in support of your goals.

  • Flow chemistry

    Product Flow chemistry

    Scale-up can be tough even for reactions that are well-established in the lab. With profound expertise in the field of flow chemistry CARBOGEN AMCIS has the capability to help you controlling conditions and handling the risk as reactive volumes are small at any time. The range of applicable conditions such as temperature and pressure is becoming larger than in classical batch reactors. Not only will our experience in this method allow you a safer reaction and easier scale-up - it will also increase the purity of a product.
    CARBOGEN AMCIS Flow Chemistry capabilities:
    - Process intensification - temperature control, mixing, pressure, concentration
    - Resolving scale-up problems
    - Handling of critical reactions and control of reaction parameters
    - Manufacturing under GMP
  • Chromatography

    Product Chromatography

    At CARBOGEN AMCIS, our preparative chromatography capabilities have been developed and optimized over the last 20 years. Our experts are able to guide you through our extensive centralized solutions, with the goal to tailor an optimal preparative chromatography program; all based around your objectives, at every stage of the drug development cycle. Our capabilities allow us to isolate an impurity, down to milligram-levels and enable purification of hundreds of kilograms of an intermediate or API from a multi-step synthesis. We are able to isolate pure substance in dedicated facilities for HIPO and non-HIPO compounds. Additionally we offer the separation of enantiomers in highly efficient continuous process or in batch process.

  • ICH Stability Studies and Integrated Analytical Services

    Product ICH Stability Studies and Integrated Analytical Services

    Through many years of experience being the API development partner of choice, CARBOGEN AMCIS has a deep and wide understanding of the critical need to perform stability studies as well as forced degradation studies to support drug development.

    We have the experience and capability to assess drug storage or shipment conditions, expiration date, and packaging. These studies provide a thorough understanding of the chemical behavior, degradation pathways and the intrinsic stability of a new molecule.

  • Crystallization

    Product Crystallization

    Defining the best crystalline form of an API is crucial in drug development, since it has a significant impact on the effectiveness of the formulation and, therefore, the bioavailability of the finished dosage form. CARBOGEN AMCIS has established a capability that supports our customers with crystallization investigations, including solubility tests, salt screening, and optimization of the crystallization process and the solid-liquid separation in the API isolation process. Polymorphism screening complements the service portfolio.
  • Cholesterol and Lanolin Derivatives

    Product Cholesterol and Lanolin Derivatives

    CARBOGEN AMCIS B.V. offers a wide range of Cholesterol products as well as Lanolin Alcohols/derivatives. These high quality products are produced at our Veenendaal site in The Netherlands. Production, but also sales and worldwide distribution to our customers is exclusively managed from this site.
  • Vitamin D Analogs and D2

    Product Vitamin D Analogs and D2

    CARBOGEN AMCIS B.V. is active in the manufacturing, marketing/sales and distribution of Vitamin D analogs and Vitamin D2 (Ergocalciferol). These ingredients (APIs) are mainly used in pharmaceutical products. Through our history of Philips, Roxane, Duphar, and Solvay Pharmaceuticals, we have more than 70 years of experience in the development, production, and sales of these ingredients (APIs). Our production site in the Netherlands is operated under cGMP regime, is certified as EU GMP, and classified as acceptable by US FDA for API manufacturing. We have our own testing laboratory. We control the complete supply chain by manufacturing our own raw material for these Vitamin D ingredients. From the Netherlands we ship these products worldwide. We can also be your partner for HIPO contract manufacturing and/or contract research (CRAMS) of Vitamin D related intermediates and APIs.

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