Case Study 3 - Formulation Development/Dosage Form Change
Customer Need:
An early stage biotechnology company had a drug candidate entering pivotal clinical trials shortly. To ensure product success, the route of administration had to be changed to either sub-cutaneous (Sub-Q) injection or intra muscular (IM) injection. The dose of the biotherapeutic was 2 mg/kg. The present route of administration was infusion of a 5 mg/ ml solution (28 mL infusion).
The goal was to increase the concentration of the therapeutic to 100 mg/ml, thereby, allowing a 1.4 ml injection. Product issues such as stability and aggregation were discussed.
Formatech Plan:
The product development team at Formatech put together a timeline for a formulation development program. To begin the project, the Formatech Stability FingerPrinting™ program was implemented to determine the obvious and latent instabilities of the biotherapeutic. The goals of the project included:
- Evaluation of the biotherapeutic in its present formulation buffer and in new formulation buffers under accelerated stability conditions
- Examination of structural stability using RALS and IF
- Development of a new stability indicating assay to be used in excipient screening
- Development of a formulation capable of supporting the desired concentration
- Development of a lyophilization cycle specific for this optimized liquid matrix
- Short term stability assessment
Solution:
A new lyophilzed, 100 mg/mL dosage form was created. The biotherapeutic entered Phase 3 with the new formulation using the Sub-Q route of administration. The accelerated stability data and newly developed stability indicating assay provided support for the filing.
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