🧪 Validogen emphasizes leveraging expertise early to prevent issues during GMP production.
💡 Startups often rush into production without robust processes, risking inefficiencies.
🔍 Effective process understanding, even at basic levels, aids in long-term success as authorities increasingly expect it.
Introduction:
The article discusses the critical importance for small biotechnology companies to develop robust bioprocesses early in the product development cycle. It emphasizes that early engagement of process development expertise can prevent delays and financial losses associated with scale-up failures during Good Manufacturing Practice (GMP) production.
- Early process development is essential to avoid time and financial losses associated with manufacturing failures.
- Many companies risk premature entry into early-stage production without thorough process evaluation, particularly with diverse protein formats.
- Monoclonal antibodies represent a more standardized production approach, while newer protein formats introduce complexity in process tuning.
- Startups lacking Chemistry, Manufacturing and Controls (CMC) expertise should leverage available expertise during initial development phases.
- Quality by Design (QbD) principles should be integrated from the start to facilitate a better understanding of the production process and regulatory requirements.
Conclusion:
In summary, small biotech companies that prioritize early bioprocess development and engage with experienced professionals are better positioned to navigate the complexities of modern protein production while minimizing risks of developmental setbacks. Embracing Quality by Design from the beginning is paramount as regulatory agencies increasingly expect a comprehensive understanding of production processes.
