Know your freeze-dried product and your lyophilization process
The development of a lyophilized formulation and the corresponding freeze-drying process go hand in hand. An in-depth characterization of the freeze-dried powder during process development provides all relevant data our expert scientists require to optimize critical process parameters. We take in-process samples throughout the lyophilization process by individual shelf-closure to test the characteristics of the product at various process stages and to obtain samples with different residual moisture content for stability studies.
We characterize every aspect of the lyophilized product
Our scientific experts characterize the appearance and structural state of the freeze-dried powder, the reconstitution time and behavior, the residual moisture in the headspace and of the freeze-dried powder, the specific surface area, as well as glass transition temperature of the freeze-died amorphous product (Tg).
Besides analytical characterization of the lyo cake, we perform long-term stability studies according to ICH guidelines as well as forced degradation studies with relevant stress conditions and apply a suitable set of stability-indicating methods from our large portfolio of more than 100 analytical techniques. This way we assure that the lyophilized product fullfils the highest quality standards and is stable over the intended shelf-life.
Analyzing your lyophilized drug product
We offer the analysis of chemical changes for the following product types. This service is based on our broad scientific experience with a large variety of biopharmaceutical samples. We will tailor each project to your specific product type, development phase and material availabilities. Click on a product type to explore our entire portfolio of specialized analytical as well as research and development services.
Quality & biosafety level of this service
We provide all our services with the highest quality standards. Each project is carried out by experienced scientists and every report or data presentation is comprehensively checked by a scientific reviewer. We offer this service with the following quality and biosafety level:
From generic to custom analytical methods and beyond
We offer a large selection of generic analytical methods for many common applications or develop custom methods specific for your needs. Our expert scientists also perform a method feasibility to assess, which technique is most suitable for your request. We offer the following options:
Methods ready to use
Our expert scientists have established generic analytical methods for many common applications. This guarantees a quick turnaround for sample testing and reduces the need for method adjustments to a minimum.
We suggest generic methods for your sample based on our many years of experience with similar products and analytical questions. If you reach a development stage, where fully developed and documented methods are required, we can build upon our expertise in customizing and optimizing any analytical method.
During method development, we tailor sample preparation, method settings, and data analysis to the needs of your project and sample.
For this purpose, we include a representative sample and, where available, suitable reference standards and stressed/degraded materials. This way, our analytical scientists can design a method that is highly suitable for your needs, stability indicating, as well as robust and repeatable. Upon request, we compile a detailed method description for your records.
A method qualification is the initial assessment of the performance of an analytical procedure to show that it is suitable for the intended purpose.
During method qualification, our analytical scientists perform documented testing to establish and assess acceptance criteria in several performance characteristics. These may include repeatability, linearity, intermediate precision, robustness and more. We compile a qualification plan and a qualification report including all relevant data.
Our know-how related to lyophilizate analytics
Coriolis is a science-driven service provider. We perform internal research projects with academic and industrial partners to develop new technologies and create in-depth knowledge, which directly benefits our client projects. Our internal Unit Science & Technology, hosting PhD candidates and Postdocs, also actively contributes to the scientific community with numerous peer-reviewed publications each year. Explore our latest publications, articles, and webinars:
Dominik Brandstetter, Constanze Helbig, Kentaro Osawa, Hiroyuki Minemura, Yumiko Anzai, Tetsuo Torisu, Susumu Uchiyama, Tim Menzen, Wolfgang Friess, Andrea Hawe
Our other services
Coriolis provides a wide range of science-driven and tailor-made solutions for research, development, and analytical challenges. Explore our other services and learn more about how we can support your drug development program. Together, we can make future therapies available to patients and improve the quality of life for humankind.