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Published on: December 15, 2017
Importance of technical operations: lessons from evolving biotherapeutics production methods
Pratik Jaluria1, Derek N Adams
1Fermentation and Cell Culture Development, Technical Operations, Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, USA. jaluriap@alxn.com
Trends in Biotechnology
|September 22, 2009
Summary
Technical operations are crucial for research and development, not just product design. This study emphasizes their importance, using biotherapeutics production as a case study for improvement.
Area of Science:
- Biotechnology
- Pharmaceutical Sciences
- Process Engineering
Background:
- Research and development (R&D) often overlooks technical operations, focusing narrowly on innovation and design.
- This limited scope can hinder the successful translation of novel technologies into viable products.
- Technical operations are integral to the entire product lifecycle, from development to manufacturing.
Purpose of the Study:
- To underscore the critical role of technical operations in R&D.
- To propose solutions for integrating technical operations more effectively into the R&D process.
- To leverage historical insights from biotherapeutics production to inform current practices.
Main Methods:
- Analysis of historical biotherapeutics production methods.
- Review of current R&D practices and their limitations.
- Identification of key advances in technical operations relevant to product development.
Main Results:
- Technical operations are essential for scalable and efficient product realization.
- Outdated production methods offer valuable lessons for optimizing current processes.
- Recent advances provide new opportunities for enhancing technical operations in R&D.
Conclusions:
- Integrating technical operations is vital for successful R&D outcomes.
- Learning from past biotherapeutics production challenges can improve modern development.
- Embracing advances in technical operations can drive innovation and product success.
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