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Industrial Transfer of Clinical Drug Products

Our team of specialists excels in every aspect of technical transfers

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CARBOGEN AMCIS facilitates drug product scale-up from development scale through to commercial manufacturing, tailored effectively to bridge the gap between early-stage clinical trials and commercial scale.

As products progress from Phase I, to Phase III and ultimately to commercial scale, scale-up involves not only a quantitative increase in production but also a qualitative shift in the level of process understanding and control. Technical transfer and process validation are key during this phase.
  • Elevate your product from the lab to the market with precision and care
  • Integrated clinical and commercial drug that increases operational efficiency, maintains strict product specifications, and reduces manufacturing costs
  • Diligent evaluation of key process parameters with consistent follow-up to ensure that each product maintains its integrity and efficacy throughout the transfer and scaling processes
  • Close attention to ensure that the clinical drug product retains its integrity and therapeutic efficacy as it is scaled-up and ultimately resulting in the successful manufacture of a commercial drug product

Life Cycle Management of Drug Products

At CARBOGEN AMCIS we offer life cycle management strategies to achieve continued success and competitiveness of your pharmaceutical products. We develop strategies for existing formulations and seek ways to constantly improve and extend the presence in the market.

Our methods of assessing reformulation and process optimization are deeply rooted in our knowledge of the pharmaceutical industry and regulatory landscape. We identify opportunities for improvements in your products, whether that be efficacy, stability, cost effectiveness, or streamlining processes. We focus only on the areas where your efforts will yield the greatest impact and provide techniques to enhance your products. This reformulation has the goal of setting the benchmark in the industry, keeping you ahead of all competition.

CARBOGEN AMCIS is your partner of choice for reliable and sustainable life cycle management to support the success and competitiveness of your products.

Life Cycle Management of Drug Products
Tech Transfer for Drug Manufacturing

Tech Transfer for Drug Manufacturing

The process of transferring technology is complex as there is need to ensure that a new drug manufacturing process is moved — in a compliant manner — from one phase or location to another.

The process of transferring technology is complex as there is need to ensure that a new drug manufacturing process is moved — in a compliant manner — from one phase or location to another.

Our team of specialists excels in every aspect of technical transfers, offering customized solutions tailored to the needs of each project.

  • 25°C / 60% RH,
  • 30°C / 65% RH,
  • 30°C / 75% RH,
  • the more stringent 40°C / 75% RH,
  • as well as specialized settings for products requiring storage at 5°C, -20°C,
  • and even as low as -80°C.

Our experts can support you in all configurations of technology transfer. Our experience and flexibility guarantee the safe transfer of your commercial product to our Saint-Beauzire site for manufacturing. We are also experienced in scaling up or down based on your project requirements.

Furthermore, we extend process validation services, for production underpinned by rigorous quality control measures that ensure each product batch meets stringent quality standards.

Our technology transfer services are a combination of precision, expertise and a commitment to excellence.

From Clinical to Commercial

The change from clinical to commercial manufacturing is a pivotal stage in the drug product life cycle, and CDMOs are crucial at this stage as they assist at many crucial steps throughout the commercial drug supply process, including scaling up, validating processes, devising regulatory strategies, guaranteeing compliance, QA/QC, supply chain management, risk assessment/mitigation, technology transfer documentation and personnel training and support.
From Clinical to Commercial

CARBOGEN AMCIS aids in the progression from clinical to commercial drug product supply and production through a wide range of services.

  • Our team specializes in creating strategies to address the specific requirements of each transfer and guaranteeing a seamless transition and commercialization process
  • We assess the need for process enhancement or reformulation while identifying opportunities for enhancing efficiency and product quality
  • Our approach to optimizing processes and reformulating them is founded on our background and technical knowledge
  • In order to guide your product from trials to market success, we offer scale up services. To ensure that every aspect is optimized for commercialization we carefully handle technical transfers and qualifications
  • Our focus on quality control involves internal batch analyses and close collaboration with analytical partners to uphold our stringent standards, for each product

We aim to be your partner in navigating the complex path from clinical excellence to commercial success, ensuring that your product not only meets but exceeds market expectations.

Our technology transfer services are a combination of precision, expertise and a commitment to excellence.

For more information download our Development & Aseptic Production of Drug Products brochure or contact us today.

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