From Lyoptimus we are aware that thermodynamics, and heat and mass transfer, are normally out of the scope of chemistry, biology and pharmacy, as well as low temperature and high vacuum technology, which needs to be compliant with the high demands of pharma regulations, pressurized vessels, and even in some cases, being exproof. Therefore the aim of Lyoptimus is to complement our partners with the necessary knowledge and expertise, for enhancing their capabilities on pharmaceutical development and pharma lyophilization.
Excipients included at the drug formulations, need to be conveniently defined according the freeze drying process, for protecting the Active Product Ingredient (API) from the stress of the production process, but also making the cycle time viable. The recipe optimization of the cycle will stablish the production capacities and size of the required equipment. From Lyoptimus we can at early stages of a project, provide key estimates for the best decision making.
The new biological pharmaceuticals, as well as the recently updated regulations for sterile products (GMP Annex 1), are changing the classical approach for producing sterile lyophilizates. Batch sizes are getting smaller with personalized medicine, quality requirements are now more demanding for drugs delivered parenterally (when the API is bypassing all the body protections against external agents, delivered for example directly to the blood stream by injection).
Adjusted solutions for these new challenges, require case by case analysis, and Lyoptimus is specialized and ready to join the process designers during the drug and pharma plant development, providing smart solutions to overcome the new challenges of the new pharmacy to come with biologics lyophilization.