White Paper: Establishing cGMP Manufacturing Capability for Phase 1 Sterile, Dispersed, Injectable Dosage Forms
As a product transitions from pre-clinical development to a clinical development phase, the manufacturing process takes on a much greater role in the overall success of the project. This transition is particularly difficult for emerging pharmaceutical companies whose expertise typically lies in the biology and chemistry of how their drug interacts with targets in the body, and less on the engineering, regulatory and quality aspects of manufacturing the drug product. This critical milestone is made even more challenging when the drug product is intended to be a sterile, injectable dosage form as the manufacturing and quality requirements can be overwhelming for a small company. Most small pharma companies turn to Contract Development and Manufacturing Organizations (CDMOs) to outsource this activity, as the cost to establish the capability internally often does not merit the investment for an early-stage product. Click here to download/view the complete white paper.
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