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Pharmaceutical Industry: New Product Development

Capability

Turnkey Solutions

Client

A major pharmaceutical company with global operations

Problem

The client wanted to shorten the time to develop new products and safely reduce the number of development studies by creating a knowledge base designed to grow as additional studies were added to it.

Approach

A Tunnell consultant with extensive expertise in product development reviewed reports for the development of drug products for three new chemical entities (NCEs). The three NCEs were of different classes (1, 2, and 4) in the Biopharmaceutics Classification System (BCS). Using criticality analysis, the consultant determined which studies could be eliminated with no risk of future problems with the products. Working closely with the client, the Consultant:

• Graphically represented the interaction of the product design criteria for a product with its critical quality attributes (CQA’s) and the intermediate process steps with critical process parameters and in-process characteristics and the material attributes of the active pharmaceutical ingredient (API) and excipients
• Reviewed 42 development studies, technology transfer reports, and batch records in multiple document management systems and extracted the data for the knowledgebase
• Developed spreadsheets for each intermediate process comparing the equipment, batch size, critical process parameters, and in-process characteristics for multiple batches of the three products with references for each batch
• Identified items to be included in future development and technology transfer reports to ensure the availability of data for the knowledge base that would improve decision making 

Results

• Created an expandable, reusable knowledgebase that doesn’t rely on experienced scientists, but on company-derived knowledge from reports that can be referenced for regulatory purposes
• Enabled the avoidance of four different development studies
• Achieved time-to-market savings of two to four months
• Realized cost savings of over $100K (depending on the cost of the API)

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