Tofflon’s lyophilization laboratory is fully equipped to conduct in-depth research on the entire lyophilization process. It is designed to provide complete solution for lyophilization processes that meets GMP requirements. We are committed to help our customers to improve their product quality, reduce production cost and increase production efficiency. By combining strategic research and in-depth industry knowledge, Tofflon’s lyophilization laboratory is able to deliver the most optimized solution in a safe and orderly environment.
·Equipped with world class freeze-drying, testing and analysis instruments in the industry, especially Tofflon’s extensive series of freeze dryers; ·As of 2019, the laboratory has processed over 1,000 freeze-dried applications e.g. fosaprepitant dimeglumine, ertapenem, gemcitabine hydrochloride, rituximab antibody, camrelizumab antibody, durvalumab antibody, etc; ·Extensive working experience with over 300 international and domestic establishments such as SK biopharmaceuticals, Hanmi, Boryung, Wockhardt, Pharmasyntez, Anfram etc; ·Vast experience in troubleshooting, problem diagnosing and solving, even for complex issues like residue organic solvent amount over limit, diameter control for particle products, product stability decrease, residual activity decrease, etc. ·Substantial researches in the frontier field of the latest freeze-drying applications; e.g. freeze-drying product formulation stability study by molecular simulation means and freeze-drying process calculation by DPE software, etc.
During the development of the freeze-drying process, critical temperatures need to be identified at each different stage. Through the parameter testing service provided by Tofflon’s laboratory, these critical temperature points will be easily identified at various stages such as freezing temperature, sublimation temperature, desorption drying temperature, etc. The service generally gives collapse temperature, eutectic temperature or glass transition temperature.
The lab-scale freeze-drying process development is the first step in the preliminary development stage of the pharmaceutical preparation. Tofflon’s Laboratory provides the commissioned service to obtain high-quality product appearance and optimized product moisture content (average), etc.
Through process optimization, the freeze-drying cycle of the product can normally be shortened. When the freeze-drying rate of the product can be improved, energy consumption is further reduced for each production batch, indirectly customer gains a competitive edge with such process optimization.
Due to the size proportion difference between the laboratory equipment and the pilot and production equipment, there is a significant difference in mass transfer and heat transfer between them during the freeze-drying process. This difference also leads to the different positions of the vials. The difference in the lyophilization process of the product may increase or decrease of the product temperature during the sublimation phase, or even extension of the freeze-drying cycle.
Various problems may occur during the product development or production phase, such as product activity, turbidity, residual organic solvents, dissolution rate etc. We can provide customized assistance according to your specific requirements.
We provide classroom and customized training based on your needs.
