The development and manufacturing of sterile drug products require skills and long-term experience in pharmaceutical sciences, microbiology, engineering and process development.
This expertise extends from drug formulation and sterilization methods to aseptic pharmaceutical manufacturing. A solid understanding of regulatory standards is also requested for safe development and production of sterile drug products following Good Manufacturing Practices (GMP) and other applicable guidelines.
Drug Product Development Services
CARBOGEN AMCIS provides pharmaceutical development and formulation services that demonstrate its commitment to quality and excellence.
This includes the development of liquid or lyophilized drug products, ranging from formulation work with choice of solvents, co-solvents and excipients to on boarding existing formulation and even formulation life cycle management. The developed formulation can be used for pre formulation studies, toxicogical or proof of concept studies.We offer a broad range of services, including non-GMP, low-bioburden drug product manufacturing facilities, in order to meet early drug development challenges today.
At CARBOGEN AMCIS, we are prepared to work with you on a key component that is important for the success of your drug product. This is why we will ensure that your projects are compliant, effective, and safe.
Industrial Transfer
Industrial Transfer is crucial in different stages of a drug product life cycle:
- Between development and GMP manufacturing for a clinical product
- But also for the transfer from manufacturing site to another one
- For scale up and / or optimization of the drug product manufacturing process either clinical or commercial.
Drug manufacturing processes are transferred from one facility to another typically for scale-up, cost reduction, or strategic growth in a new market.
CARBOGEN AMCIS assist in providing a framework of our service to effectively close the gap. As we move forward, we carefully carry out technical transfer, qualification and validation. We also conduct a complete review of critical process parameters. Careful monitoring of the drug product is critical at any stage to maintain its quality and therapeutic efficacy.
Trust CARBOGEN AMCIS to elevate your drug product from the laboratory to the market.
Clinical and Commercial Drug Product Manufacturing
Bringing Drug products into the market depends on two critical phases, clinical and commercial manufacturing.
CARBOGEN AMCIS is committed to the improvement of global health and excellence in both clinical and commercial manufacturing. Our facility is equipped to manufacture both liquid and lyophilized drug products, to adapt to the changing needs of the pharmaceutical industry. Our approach to clinical drug manufacturing is tailored to support the critical stages of clinical development, ensuring that each batch is produced to the highest standard of quality. As we transition to commercial drug manufacturing, our expertise expands to meet the demands of the commercial market. Our state-of-the-art commercial manufacturing facility now using two fully automated manufacturing lines, each with Grade A Isolator technology, providing the environment required to manufacture safe, effective pharmaceutical injectable products.
CARBOGEN AMCIS brings advanced technologies and an unwavering commitment to quality to the pharmaceutical industry - from development to delivery.
Release Testing and Stability Studies
Release testing and Stability testing are critical not only for compliance with regulatory agencies such as the ANSM (French authorities), FDA or EMA, but also for trust among healthcare professionals and patients. .
CARBOGEN AMCIS specializes in comprehensive services including batch release and in-house stability testing. We have the expertise to implement and develop analytical methods to ensure accurate and reliable results. We offer stability storage under various ICH conditions and testing for all injectable Drug Products, we develop and manufacture. For all pharmaceutical requirements, we are equipped with state of the art analytical, microbiological and biochemical laboratories, which ensure quality and compliance at every stage.
We at CARBOGEN AMCIS provide reliable, compliant, and secure storage and testing capabilities that maintain and ensure the quality of your drug products from development to delivery.
QP Services & Regulatory Support
CARBOGEN AMCIS offers excellence in quality assurance services and end-to-end global regulatory affairs services.
Our QP services ensure that each batch release takes place on schedule and in total compliance with stringent standards, ensuring rapid market access. We are experts at developing strategies for navigating complex regulatory landscapes, giving clients a clear path through the complex set of approval processes. Our record of success in preparing CMC (Chemistry, Manufacturing, and Controls) sections is another example of our exceptional commitment to complete, robust, and accurate documentation.
We at CARBOGEN AMCIS can help you navigate the complex pharmaceutical regulatory landscape successfully.
For more information download our Drug Products brochure.
