Lyophilized formulations
A lyophilized products is a valuable alternative to a liquid formulation
Biopharmaceutical molecules are often inherently unstable and the most frequently used excipient, water, mediate most if not all possible degradation reactions. Thus, a liquid formulation development may not always be successful and a lyophilized (freeze-dried) formulation is the only way to achieve a stable product.
The decision to develop a lyophilized formulation is either…
Stability-driven
Lyophilization process development is done subsequent to a liquid formulation development.
Longer development timelines in case the liquid formulation does not deliver the desired product quality or stability
Timeline-driven
Lyophilization process development is done in parallel to a liquid formulation development.
Readily available fallback option in case the liquid formulation does not deliver the desired product quality or stability
Coriolis has many years of experience and the technical capabilities to develop both, liquid and lyophilized formulation subsequently or in parallel in a tailor-made formulation development that fits your timelines and budget. We can offer a complete lyophilization process development including the selection of suitable excipients, bulking agents and buffers. Also, our large portfolio of analytical techniques for the physico-chemical characterization of lyophilizates, ensures that the freeze-drying process runs at optimal conditions and that the final product will meet the highest quality criteria.
