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Client Profile
A small biotechnology company with less than
50 employees and a drug in two clinical trials.
Business Need
The Client wanted to reformulate their drug into
a lyophilized dosage form with a rapid freeze-drying cycle. Timeline for the project was six months that included three months
for stability at accelerated storage conditions.
Technical Challenge
The historical data on the drug suggested
a number of potential stabilizing excipients but the data was limited. Our job was to systematically identify the critical
formulation parameters required to stabilize the drug in a lyophilized state.
HTD Services
We worked with our client's
scientific and clinical team to finalize the Product Target Profile for the protein drug. HTD discussed the formulation parameters
with the Client's scientists and developed a high throughput stability-indicating assay for the protein. We evaluated 6 variables
simultaneously using a statistically designed multivariable experimental design that evaluated approximately 40 trial formulations.
A number of potential formulations were lyophilized and characterized in detail to identify formulations for long term stability
studies. Detailed biophysical characterization demonstrated that the protein retained its conformation during lyophilization
and reconstitution. Three formulations were manufactured at small scale and put on stability. We worked closely with our client
to identify the optimal formulation and developed a lyophilized cycle that was rapid and scalable.
Results
An optimal
stable formulation was developed less than six months after the project was initiated at HTD. A patent for the formulation
was filed by the Client. The formulation was transferred to the manufacturing facility and the product was lyophilized successfully
at large scale.
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