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Release Testing and Stability Studies for Drug Products

Highest quality and compliance throughout all stages

Release testing and accelerated stability studies programs are designed to ensure that new drug substances and pharmaceutical products are safe, effective, and of the highest quality.

Release testing and accelerated stability studies programs are designed to ensure that new drug substances and pharmaceutical products are safe, effective, and of the highest quality.
  • Comprehensive services that include batch confirmation / certification, and stability testing of new drug products
  • Expertise in analytical method transfer and development guarantees highly accurate and reliable results
  • Stability storage under various conditions at our Saint-Beauzire (France) site (-20°C, 5°C, 25°C/65% RH, 30°C/60% RH, 40°C/75% RH). Strong capabilities in the testing of liquid, freeze-dried injectables, conventional, and highly potent compounds
  • Strong capabilities in the testing of liquid, freeze-dried injectables, conventional, and highly potent compounds

Storage Capability for Drug Substances and Pharmaceutical Products

At CARBOGEN AMCIS, we ensure the highest standards in pharmaceutical drug product storage. Our Drug Product facility in Saint-Beauzire follows ICH /GMP/GDP guidelines to ensure that stability and quality are preserved at every stage.

We are specialized in secure storage of highly potent drugs in dedicated areas, to eliminate the potential for cross-contamination. Our extensive temperature-controlled environments are closely monitored, with raw materials and biological source material stored at RT/5°C/-20°C, APIs at RT/5°C/-20°C/-80°C, and finished products at RT/5°C/-20°C.

We provide reliable, compliant, and secure in-house storage capabilities that maintain the quality of your drug products from development to delivery.

Storage Capability for Drug Substances and Pharmaceutical Products
Analytical Testing of Pharmaceutical Drug Products

Analytical Testing of Pharmaceutical Drug Products

The pharmaceutical industry utilizes various analytical testing techniques and instruments to evaluate the physical and chemical properties of drug components, products, and materials. It’s critical for various reasons, such as ensuring the quality, safety, and efficacy of drug products, among others.

We are able to provide in-house solutions that go beyond basic development to include regulatory consulting, through stability studies, full analytical support including method validation, with a focus on upscaling clinical drug manufacturing processes. Our services are designed to facilitate a seamless transition between the various phases of drug substance development and manufacturing, minimizing risk and maximizing results.

At CARBOGEN AMCIS, we set the standard for analytical testing.

  • Our expert team provides analytical testing under stringent guidelines in our state of the art chemistry laboratory that further investigates raw materials and primary packaging to ensure we use only the highest-quality materials.
  • Testing includes method transfer, qualification and validation, to assure that results are accurate and repeatable.
  • We provide expertise that includes method qualification through to Phase II batches and full validation from Phase III to ensure precision through every phase of drug development.
  • Our facility also provides testing for product release and stability guaranteeing that every drug product meets strict standards for quality, safety and effectiveness.

Rely on CARBOGEN AMCIS for highest quality in analytic testing results and compliance in the production of drug substances and products in the pharmaceutical industry.

Microbiology Testing

CARBOGEN AMCIS rigorously follows all industry standards and test methods to ensure full safety and compliance during the microbiological testing in our in-house microbiology laboratory.

We carefully perform bioburden assessments to determine microbial contamination levels, and use stringent sterility testing and endotoxin analyses to certify that each product meets the highest standard of compliance. In addition to keeping the production environment in pristine condition through environmental monitoring, we conduct stringent monitoring of water for injection (WFI), purified water, compressed gas and pure steam to ensure top quality in all processes.

CARBOGEN AMCIS offers a broad range of microbiological testing services for your drug products, and guarantees that our testing methods meet and exceed industry standards to provide complete assurance of the efficacy, and safety, of all drug products.

Microbiology Testing
Stability Studies Management

Stability Studies Management

Stability study management is essential for CDMOs and pharmaceutical manufacturers to ensure that the drugs they develop and manufacture are safe, effective and of high quality throughout their intended shelf life.

With strict compliance to regulatory guidelines, CARBOGEN AMCIS stands for excellence in pharmaceutical stability study management. We specialize in a robust stability testing program in compliance with ICH stability guidelines for a wide range of formulations. This includes stability studies under ICH stability conditions of -20°C, 5°C, 25°C / 60% HR, and 40°C / 75% HR for liquid, lyophilized injectables, conventional compounds, and complex compounds. Stability testing is a core part of our quality control (QC) activities. Our specialist teams use carefully developed methods to ensure the longevity and reliability of each and every product we manufacture.

Choose CARBOGEN AMCIS for the management of stability studies that sets the quality standard for excellence in the pharmaceutical industry.

Biochemical Analysis

Biochemical analyses are key to quality control (QC) and quality assurance (QA) throughout the drug development and manufacturing process. Regulatory agencies require comprehensive biochemical analysis data to evaluate the safety and efficacy of biopharmaceuticals.

Reliable biochemical analysis is at the heart of everything we do at CARBOGEN AMCIS. Benefit from our extensive expertise in biochemical analysis of all drug products, with fully validated assay content and purity testing.

Our experienced professional team of chemists and analysts are skilled at developing and providing accurate analytical methods tailored to the unique needs of complex biochemical analysis.

Our operations are driven by a strong commitment to quality, extended to audits of analytical contractors and evaluations of their analytical data, and include thorough analysis of internal batches to ensure our high standards are maintained.

Count on our expertise in biochemical analysis, where our commitment to excellence is second to none and the safety and efficacy of your drug products is never in question.

Biochemical Analysis

For more information download our Drug Products brochure.