Development of an Optimized Lyophilized Drug Product for an Amino Acid Peptide Delivered via Injection Into the Vitreous Humor
Business Need
An early stage biotechnology company successfully completed a Phase I study for an amino acid peptide drug candidate injected into the vitreous humor.
Due to challenging stability issues with the peptide the company chose to investigate lyophilization as a strategy to obtain the necessary stability of its drug product for its continuing development needs.
The particular challenge to the company was that at this stage of development no excipients could be introduced to facilitate development of a lyophilized product due to concerns of changing the release profile of the peptide and correlation of data obtained previously in development.
The company, in combination with Wolfe Laboratories, established the feasibility of a peptide only lyophilized formulation with fill solutions of 3-21 mg/mL peptide.
The company was interested in developing an optimized lyophilization cycle, transferrable to a contract manufacturer and capable of accommodating fill solutions of 3 - 42 mg/mL peptide.
Technical Approach
Wolfe Laboratories successfully performed experiments that demonstrated the feasibility of developing a peptide only lyophilized product with fill solutions of 3-21 mg/mL peptide.
Wolfe Laboratories installed an HPLC method for determining the concentration of the peptide in fill solutions and the reconstituted drug products.
Wolfe Laboratories also conducted thermal, thermogravimetric, moisture content, liquid particle counting, osmolality, and pH analyses necessary for characterizing the fill solutions and resulting lyophilized product.
The results were provided as detailed reports. The optimized Lyophilization cycle was delivered on time and successfully transferred to the contract manufacturing group designated by the client.
Results
The client company achieved significant milestones as a result of its partnership with Wolfe Laboratories key in furthering the development of their drug product.
By reducing the lyophilization cycle-times by over 50%, production cost savings to the client were significant.
Based on the success of their development program the client entered into a licensing and purchasing agreement with a large pharmaceutical company.
