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Client Profile
A mid-size biotechnology company with approximately
200 employees and several drugs in clinical trials.
Business Need
The Client wanted to reformulate their current
small molecule drug that was formulated at 10 mg/ml in a lyophilized dosage form. Phase I/II clinical trials suggested that
the dose for this anticancer drug could be increased. The client wanted a lyophilized dosage form at 80 mg/ml that could
be reconstituted into a clear solution and could be manufactured with a rapid freeze-drying cycle.
Technical Challenge
The
API was a sparingly soluble drug that had to be reformulated with solubility enhancing excipients suitable for parenteral
administration. A rapid lyophilization cycle was required that could be scaled up to manufacture the drug for Phase III trials.
HTD
Services
We worked closely with our client's scientific team to characterize the protein drug using DSC and evaluated a
number of solubility enhancing excipients that were amenable to lyophilization. We employed multivariable experimental designs
to evaluate a number of formulation parameters together and identified a potential formulation that met the Product Target
Profile. Extensive lyophilization development was performed by working closely with the Client and a number of manufactured
product lots were assessed in stability studies. Lyophilization parameters were determined for tech transfer to a large scale
lyophilizer. Detailed characterization of the lyophilized product was performed for regulatory filing of the product.
Results
An
optimal stable high dose formulation was developed in less than six months after the project was initiated at HTD. The formulation
was transferred to the manufacturing facility and the product was lyophilized successfully at large scale.
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