Lyophilization Cycle Development
LSNE is uniquely equipped to develop your lyophilization cycle from scratch or optimize your existing cycle to provide you with a commercially desirable yet economical process. We use our years of experience and a sound scientific approach to optimizing your cycle to produce a stable product and an elegant lyophilized cake.
Development and Optimization
LSNE was founded as a lyophilization development specialty house starting with a single freeze-dryer.
Today, we have over 30 lyophilizers, and one of the largest lyophilization capacities in the industry.
Simply put, we are the lyophilization experts.
It’s how we got our start, it’s the cornerstone of our business, and helped us become a global leader.
Cycle development begins with understanding the critical temperatures of the formulation by utilizing:
- modulated Differential Scanning Calorimetry (mDSC)
- Freeze Dry Microscopy (FDM)
Once we determine the thermal properties of your formulated product we will use the Glass Transition (Tg’), Eutectic Temperature (Te), Collapse Temperature (Tc) and Re-crystallization Temperature (Tcry) data to develop the nominal drying conditions for lyophilization cycle parameters.
To ensure to deliver a commercially robust lyophilization process and ensure the finished product consistently meets the finished product CQAs at release, LSNE performs an “Intentional Collapse Study” (ICS) during the final stages of lyophilization development. The Process Development team will perform the ICS study to intentionally collapse the product, so we fully understand the potential points of failure for your product’s lyophilization cycle.
Conserving Your Valuable
LSNE is well versed in working with our clients to develop a lyophilization cycle specific to your product using only small quantities of your valuable API. If limited material is available for cycle development, we can develop an experimental plan with you based on the amount of API you have available for development. By establishing the testing plan around the development activities, we can use a placebo or small amounts of drug substance in the early stage feasibility runs prior to running the final confirmatory lyophilization runs.
By challenging the cycle parameters of the nominal lyophilization cycle, LSNE will optimize the lyophilization cycle specifically for your product. The cycle will be optimized for low residual moisture, cake appearance, reconstitution, and total run time. Optimizing the cycle for total run time can save you millions of dollars over the life-cycle of your product.
One important step of your clinical studies will be the required toxicology studies. LSNE can produce toxicology material at our sites located in the US and EU to supply you with material to support your preclinical studies and your IND submission.
Success Comes From Knowing
Whether you plan to manufacture your product at one of our five cGMP manufacturing sites or transfer to another CMO and only partner with LSNE for cycle development, we will deliver a robust lyophilization cycle with parameters that are transferable to any large scale freeze-dryer. Our Process Development team has an in-depth understanding of the shelf temperatures and vacuum ramp rates that commercial-scale freeze dryers can successfully achieve. We take into consideration the capabilities of large-scale freeze-dryer units as we develop your lyophilization cycle, plan for scale-up, and transfer the cycle for cGMP manufacturing.
If your manufacturing process requires the aid of organic solvents to increase solubility, we can evaluate such solvents as tert-butyl alcohol, acetonitrile, DMSO, or ethanol. We have the experience to safely develop and transfer the manufacturing processes to our cGMP manufacturing facilities. We work closely with our Environmental Health and Safety team to fully understand the maximum volumes we can safely handle.