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Matching manufacturing controls to the needs of early injectable development
Discover how biotech and pharma companies can balance microbiological quality with process flexibility to navigate the unique demands of early injectable drug development programs.
Early injectable drug development requires a careful balance between control and flexibility. Teams need material for non-clinical studies while formulations and manufacturing processes may still be evolving, making it essential to meet predefined quality requirements without limiting the ability to adjust formulations, optimize processes, or produce additional batches. For injectables intended exclusively for non-clinical toxicology studies, this does not necessarily require the comprehensive pharmaceutical quality system applied to clinical GMP batches.
Instead, manufacturing controls can be tailored to the product, process, intended use, and associated risks.
Matching manufacturing controls in practice: What does a flexible approach look like?
This white paper explores a science- and risk-based approach to manufacturing injectable toxicology batches, with particular attention to microbiological quality and contamination control throughout the manufacturing process. Learn how Thermo Fisher Scientific’s Formulation and Analytical Development Laboratory in Monza, Italy, applies targeted controls, minimized operator intervention, automated filling technology, and appropriate microbiological testing to support early development while preserving the flexibility these programs require.
The white paper also explores why a fit-for-purpose manufacturing strategy starts with the specific needs and risks of the program, including key considerations such as:
- Product characteristics
- Contamination risk
- Operator intervention
- Process relevance
- Testing and verification
