Case Study
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 subcutaneous (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 both the obvious and latent instabilities of the biotherapeutic. The goals of the project included:
A new, lyophilized 100 mg/mL dosage form was created. The biotherapeutic entered Phase 3 clinical trials 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.
To request more information on our formulation services, please click here.
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 subcutaneous (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 both 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
A new, lyophilized 100 mg/mL dosage form was created. The biotherapeutic entered Phase 3 clinical trials 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.
To request more information on our formulation services, please click here.
