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Client Profile
A mid-size biotechnology company with approximately
100 employees and drugs in research and clinical trials.
Business Need
The Client wanted to reformulate their lyophilize
drug so that its reconstitution time could be decreased significantly.
Technical Challenge
The current drug product
had reconstitution time that were unacceptable and required vigorous aggitation for upto 30 minutes! The challenge was to
reduce the reconstitution time to less than 2 minutes and develop a scalable lyophilization cycle for the drug product.
HTD
Services
We worked with our client's scientists to determine the Product Target Profile (PTP) for the small molecule drug-conjugate.
HTD discussed the formulation parameters with the Client's scientists and developed a suitable reconstitution assay to evaluate
formulations in a consistent fashion. We evaluated a number of potential solubility enhancing excipients in lyophilized dosage
forms and reduced the reconstitution time to the PTP of the drug product. Using multivariable experimental designs, we validated
the formulation and tested the robustness of the formulation. Three lead formulations were identified and lyophilization
cycles were developed for the formulations. Detailed scanning electron microscopy, X-ray diffraction, moisture stuides, and
differential scanning calorimetry studies were performed on lab scale batches. A scalable lyophilization cycle was developed
that was tech transferred to production. A manufacturing process for the lead drug product formulation was developed and
transferred to production.
Results
An optimal stable formulation was developed less than three 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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