Drug Products

Product Description

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.

CARBOGEN AMCIS

  • CH
  • 2015
    On CPHI since
  • 1
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Contract Service
Primary activities
API Producer
Clinical Research
Contract Manufacturer
Contract Research Organisation
Specifications
  • Selling Points
    A State-of-the-Art Facility Opened in early 2023, the Saint-Beauzire facility represents a major investment by CARBOGEN AMCIS (60 million euros). It underscores the company’s commitment to enhancing sterile drug product manufacturing capabilities. The 9,500m² site features two fully automated production lines for liquid and lyophilized drug products, supporting a wide range of therapeutic areas, including highly potent compounds and advanced therapies such as antibody-drug conjugates. The flexible and versatile setup is unique within Europe and fully compliant with the latest EU GMP Annex 1 standards for sterile medicinal products.

CARBOGEN AMCIS

  • CH
  • 2015
    On CPHI since
  • 1
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Contract Service
Primary activities
API Producer
Clinical Research
Contract Manufacturer
Contract Research Organisation

More Products from CARBOGEN AMCIS (7)

  • 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 molecul...
  • Clinical API Development

    Product Clinical API Development

    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...
  • 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 t...
  • 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 wi...
  • Sterile Drug Product services

    Product Sterile Drug Product services

    CARBOGEN AMCIS offers Sterile Drug Product services, specializing in the formulation, development, and manufacturing of injectable products. With capabilities in lyophilization, sterile filling, and handling highly potent APIs, the company ensures aseptic processing for clinical and commercial supply. ...
  • Drug Substance Services

    Product Drug Substance Services

    CARBOGEN AMCIS provides comprehensive Drug Substance services, offering expertise in process development, scale-up, and manufacturing of active pharmaceutical ingredients (APIs). With state-of-the-art facilities, the company specializes in high-potency compounds, including cytotoxics, and delivers solu...
  • Specialties Services and Products

    Product Specialties Services and Products

    Specialty manufacturing and services provided by CDMOs address the diverse needs of customers in various therapeutic, nutraceutical and dietary supplement areas, as well as in the pharma, personal care, and cosmetics industries.

    With over 70 years of experience, CARBOGEN AMCIS Veenendaal...

CARBOGEN AMCIS resources (4)

  • News CARBOGEN AMCIS Secures GMP Certification After Successful ANSM Inspection for its Aseptic Drug Product Manufacturing Site

    CARBOGEN AMCIS is pleased to announce the successful completion of the first inspection by the French regulatory authority, ANSM (Agence nationale de sécurité du médicament et des produits de santé), at its state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France.

    The inspection, conducted from January, 20th to January, 24th, follows the site’s opening in February 2023. This is the first inspection of a routine process by ANSM to ensure compliance with Good Manufacturing Practices (GMP). As a result, CARBOGEN AMCIS has been granted a GMP certificate for the Saint-Beauzire, France.
  • Video CARBOGEN AMCIS Secures GMP Certification

    CARBOGEN AMCIS is pleased to announce the successful completion of the first inspection by the French regulatory authority, ANSM (Agence nationale de sécurité du médicament et des produits de santé), at its state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France.

    CARBOGEN AMCIS has been granted a GMP certificate for the Saint-Beauzire facility, marking a significant milestone in the site's successful start-up. The certificate allows for the manufacture and release of clinical and commercial sterile drug products. The site received authorization from the ANSM to manufacture, test and release drug products from February 2023 and since then has been working under this authorization with the first clinical batch released in January 2024.
  • News CARBOGEN AMCIS announces major investments of more than CHF 100 million in Switzerland and France

    Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) and drug products manufacturing company, announced today new expansion plans in Switzerland and France.
  • Brochure Company Profile

    Dowload our brochure and learn more about our offers. 
    Drug development to Commercialization services for pharmaceutical and biopharmaceutical industries at all stages of drug development

    Your CDMO from Drug Substance to Drug Product

Frequently Viewed Together

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    RoSS.FILL is a fully automated filling & draining system for single-use bags and bottles in different sizes and quantities. It facilitates maximum flexibility and scalability of both the filling and draining process. It is possible to attach filling racks for unlimited volumes per batch with ...
  • Product Sterile Multidoses

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  • Product COMFORT®-system

    The airless dosage system for dispensing very sensitive liquid or semi-solid pharmaceutical as well as cosmetic formulations
    Like the 3K-system, the COMFORT-system permits avoiding any kind of preservatives, even after the product has been opened, as the special design of the system prevents contami...
  • Product Multipurpose small batch filler

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  • Product Drug Product Fill-Finish Services

    Fill-Finish Capabilities (product type) and Capacity:
    Sterile liquid products
    Biosafety level (BSL) 1, BSL 2 (OEL >= 10 µg/m³)
    Vaccines (inactivated)
    Current capacity: ~40M units/year
  • Product Filling: Ampoules, vials, syringes, pouches, bottles or blisters

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  • Product Automatic inspection machine

    +Full-servo drive control system to ensure the automatic, high-speed and stable operation of the equipment;+Up to 5 channels for bottle outfeed, sampling channel or suspected product channel are optional;
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  • Product iRestore: solutions for corneas preservation in transplantation process

    iRestore solutions are synthetic media for corneal storage. The special formulations consist of a mixture of salts, aminoacids, vitamins, nutrients and preservatives agents which are suitable for the physiological preservation of the cornea.It is well known that highly viable corneal endothelium is fundame...
  • Product Sterile Pharmaceuticals

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  • Product Pharmaceutical Filling Needles and Nozzles for Dosing Machines

    Manufactured from 316L Stainless Steel or Plastic Materials and Ketron Peek® Made-to-measure Design – Custom Made Service -Made in a Single Block and/or Laser or Tig WeldingSuper Finishing – Internal Surface of Tubes Worked in Honing Machine (RA < 0.4 µm) Roughness Report Test (Mitutoyo SJ-410®) All typ...
  • Product Isolation technology

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  • Product SYFPAC® SECUREJECT® - BFS MACHINERY FOR PRE-FILLED SYRINGES

    SYFPAC® SECUREJECT® is Brevetti Angela machine for aseptic manufacturing of Pre-Filled Syringes (PFS) and injection devices with the Blow Fill Seal (BFS) technology. It is designed for high production of plastic syringes from 0.5ml to 20ml. Starting from the polymer granule, the syringe is formed, filled a...
  • Product AP-IS - Aseptic Processing Isolator System

    THE SHORTEST WAY TO A STERILE WORLD. The AP-IS is a cGMP Class A/ISO 5 isolator system specifically designed for QC labs, pilot scale pharmaceutical production and pharmacies. It’s a flexible equipment that guarantees the best working conditions in different applications such as Sterility Testing, As...
  • Product high capacity aseptic filling - bp 460

    When it comes to high capacity production of SVP containers at the lowest unit costs, our machine type bp 460 is the first choice. Regulatory bodies consider BFS as advanced aseptic manufacturing – only one operator is required to supervise the process. Multiple containers are formed, filled and ...
  • Product Spray Dryer

    GEA Niro pharmaceutical spray dryers from R&D to large production scale. Come and discuss your Pharma Spray Drying project with us or learn more about our pharma spray drying technology. Welcome!
  • Product ISOLATION SOLUTIONS FOR ASEPTIC FILL FINISH LINES

    Combined with automated filling systems for liquids or powders, isolation technology minimizes the direct human intervention in the processing area and is now a technology that is being increasingly and rapidly adopted by the pharma industry.

    Internationally recognized as an expert in ad...
  • Product AT-Closed Vials® - RTF Vials for for injectable drugs, designed to be us...

    The vials are particularly suitable for use with sensitive advanced therapeutical products such as cell and gene therapy preparations with special requirements for processing, transport and storage. AT-Closed Vials® are designed to be seamlessly fed into robotic filling lines for automated, aseptic fil...
  • Product PLÜMAT Aseptic Filling Machines

    In the field of ASEPTIC filling of bags PLÜMAT is your first choice ONE – STOP partner for filling machines applying oRABS, cRABS or ISOLATOR containment. For the critical process of feeding pre-sterilized components we offer RTP  (Rapid Transfer Port), ATS (Aseptic Transfer System) and non-...
  • Product Contained vacuum drying

    Contamination is unacceptable and the cGMP Nauta vacuum dryer is a proven technology for excellent cleaning (CIP) and sterilising (SIP) in place. It has a closed process vessel with a cover and filter made out of one piece. This eliminates dead spots and offers validated automatic SIP/CIP. There are no oil...
  • Product Contract Manufacturing (CDMO/CRO/CMO)

    We are world's leading contract manufacturer.  
  • Product GENiSYS C

    GENiSYS C is a highly flexible aseptic filling and closing machine used for processing vials, syringes and cartridges on a single compact machine. The system is integrated with advanced features to ensure each container is handled with care and consistently produces high quality products. The system is ide...
  • Product PAPI - Potent API Processing Isolator

    Comecer isolators for containment requirements are conceived for pharmaceutical companies who require high-level protection during potent API processing. Comecer PAPI isolators for potent API processing can be equipped with a variety of devices for any kind of process: reactors skid, vacuum ovens, ...
  • Product PRIMA Z vial

    PRIMA Z vial - Cost savings through continuous aseptic production of plastic vaccine containers

    A medication container for a liquid vaccine can use plastic instead of glass thanks to ZAHORANSKY's advanced injection mold tooling and manufacturing equipment. This is accompanied - due to the eliminatio...
  • Product Cgmp lab freeze dryers

    Shanghai tofflon science & technology co. Ltd offers a wide range of auto loading systems which includes cgmp lab freeze dryers. Features: it is cgmp designed, cylindrical process chamber and external condenser located behind freeze-drying chamber, air cooling and water cooling compressor for option. Contc...
  • Product Sterile drug product CDMO services

    Thermo Fisher Scientific's flexible aseptic manufacturing and sterile fill finish solutions for your molecule’s unique needs and challenges will enable success in early development, late-phase, and commercial manufacturing.

    Thermo Fisher offers extensive sterile product development and commercial ...
  • Product MC DecJet® Spiral Jet Mills

    The new 4th generation MC DecJet® systems stand for: • Narrow Particle Size Distribution (PSD)
    • Simple and rapid assembly/disassembly • Limited number of components • High yields • Low energy consumption • Sterile manufacturing • PSD scalability with all MC DecJet® models
  • Product Aseptic Containment Isolator for Micronization

    KEY BENEFITS OF THIS ASEPTIC CONTAINMENT ISOLATOR:

    - Integrated System: FPS provides both the containment system and the micronization unit, offering a comprehensive solution.

    - Sterilization In Place: All components of the micronization units are designed to...
  • Product SVP / LVP MIXING VESSEL

    CAPCITY: 20 LTRS TO 10000 LTRS. Complete vessel designs as per ASME Code. Instrumentation & connections comply with BPE & EHEDG guideline. Zero dead leg Aseptic design Flush Bottom Outlet diaphragm valve. Vessel design & fittings are designed for CIP / SIP able. Volume monitoring by load c...
  • Product Trial filling

    Injection solutions, inhalation solutions, infusion solutions, eye drops and gels, topical agents, oral agents, rinsing solutions, or contact lens cleaning agents – whatever it is you want us to fill, we will conduct trial filling to make sure your products always end up in the best possible containers.
  • Product VHPS Robot

    Walking and bio-decontaminate automatically. Laser navigator. Establish the 2D map and pre-set the route for bio-decontamination. Designed for multi-rooms and complex clean rooms Controlled by PLC plus Pad
  • Product The SP Line of Sight™ Approach - Accelerate Your Formulation Development...

    Line of Sight™ is a data rich set of lyophilization technologies and process analytical technology (PAT) tools designed to overcome critical lyophilization challenges during development, scale up and manufacturing of biologic products. It also enables continuous process monitoring and improvement as ex...
  • Product NEW Hybrid Model 700 Series Blow Fill Seal Machine

    Filling range 0.1mL - 2000mL 

    100 % Stainless SteelHighest quality parts 

    Tooling manufactured in the same facility 
  • Product Easy Tear Tyvek Autoclave Bags

    Easy-Tear Tyvek bags from Keystone Cleanroom Products are designed to satisfy the most stringent requirements in the sterilisation of critical pharmaceutical equipment and components. Easy-Tear Feature for easier opening and sealing No sterile cutting instruments required to open the bag Low parti...
  • Product Virtuosi VR powered by QxP

    Virtuosi powered by QxP is the world's first and only comprehensive multi-language immersive training platform for pharmaceutical manufacturing operators in aseptic processing, microbiology, and cell and gene therapy processing. The platform combines in-depth teaching videos with highly immersive virtual r...
  • Product FLUENT® In-Line Heaters

    Watlow’s new FLUENT® in-line heater is a small, lightweight, high-performance heater that can replace both a traditional immersion type heater or a heater wrapped around a tube as part of a thermal system. FLUENT features an all stainless steel construction for a clean, non-contaminating heat source. ...
  • Product GENiSYS R

    GENiSYS R is an aseptic filling and closing system that solves small-batch production challenges. GENiSYS R uses flexible robotic automation to process ready-to-fill vials, syringes and cartridges. GENiSYS R offers standard modular configurations that allow the system to be tailored with isolator systems, ...
  • Product Complete Plant

    Complete Plant with Automatic HMI
  • Product Steam sterilisation chevron peel pouch with steam indicator and hang hol...

    Improve the prep time, performance, microbial barrier, and cleanliness of your autoclave peel pouches. Manufactured and packaged in certified ISO6 Cleanroom Integrated Hang Hole is ideal for use with Isolator VHP decontamination cycles Easy, fast, and reliable self-sealing closure system Autoclavable a...
  • Product bottelpack filling machine: bp364

    Rommelag ENGINEERING offers a wide range of products which includes bottelpack systems bp364 - aseptic Blow-Fill-Seal packaging machine for the production of bottles. Filling volume 200–2,000 ml. Output 1,800–10,000 pcs./h. Contact us for more information.

    Extras: · Cool BFS to...
  • Product Engineering

    Engineering for complete plants
  • Product SA25 Aseptic Filling Workcell

    The SA25 Aseptic Filling Workcell is a gloveless robotic isolator for the automated filling of liquid or lyophilized therapies. The SA25 fills syringes, vials or cartridges. The rapid changeover between formats and the use of nested, pre-sterilized containers increases uptime and supports producing multipl...
  • Product Containment & Aseptic Barrier Isolator Systems

    n the global pharmaceutical market with the ever growing demands on materials, operator and environmental protection, consideration toward increasing standards of safety, sterility assurance and regulatory compliance has never been higher.

    As applications expand into less traditional are...
  • Product bottelpack system bp 460

    When it comes to high capacity production of SVP containers at the lowest unit costs, our machine type bp 460 is the first choice. Regulatory bodies consider BFS as advanced aseptic manufacturing – only one operator is required to supervise the process. Multiple containers are formed, filled and ...
  • Product Process development

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  • Product EPDM Glove - PIERCAN

    EPDM glove can be used in Isolators, RABS and Gloveboxes. With excellent chemical, ozone and UV resistance, excellent resistance to sterilizing agents (VHP, autoclave and gamma irradiation) and in compliance with FDA CFR 21 177.2600, this PIERCAN glove has various applications in the Life Science (Pharmace...
  • Product Bioreset Plus

    The most complete and versatile V-PHP generator of its category. Bioreset Plus can be used either inside or outside the environment that should be decontaminated and it is easy to move with its pivoting wheels.
    • Ergonomic Italian design for maximum operator comfort • Communication via Ethernet co...
  • 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 molecul...
  • Product Aseptic Split Butterfly Valve - ChargePoint AseptiSafe®

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  • Product INJECTABLE LIQUID FILLING MACHINE

    Injectable Liquid Filling Machine Use to Fill Accurate Injection. As We Understand The Importance Of Injection, Our Machine is Highly Suitable For Accurate Filling. It is With Less Maintenance And High Production.