Formulation Development

We run a new path in lyo-cycle design to quickly and efficiently generate a dry and elegant lyo cake without compromising process safety and stability of the product.

Our pilot lab is equipped with all relevant process technologies which are also used in aseptic industrial manufacturing of final drug products.

Our Development 

Every freeze-dry formulation is structured around its active pharmaceutical ingredient (API). Nevertheless, a formulation will also include a number of excipients, such as stabilizers, buffers, pH adjusters and bulking agents. A poorly planned arrangement of excipients can put the stability of the API itself at risk. On the other hand, a well-chosen excipient formula can support a lyophilized product for a long shelf-life and a stable level of biological activity.

The conception of the formulation and the selection of suitable excipients is a truly transcendental phase in the development of any lyophilized product for its large-scale manufacture. A good formulation allows a greater stability of the active principle and provides protection against the stress suffered during the same lyophilization process.

LyophilizationWorld lab offers its experience and knowledge to minimize the problems arising during the formulation development, as well as tools that facilitate the manufacturing at our client's plants (PATs).