CDMO 2.0: Three pharma industry trends for 2024 and beyond
January 25, 2024 (15 minute read)
The quality lever: Shaping success in CDMO partnerships
February 09, 2024 by Staff writer (20 minute read)
Category | CDMO Services
Speed, cost, and quality. In the dynamic landscape of pharmaceutical manufacturing, these are the three levers that influence the trajectory of every project. While all three are crucial, the quality lever is a lynchpin, holding the entire system together. Without this key lever, progress would be significantly compromised, even if the other levers are functioning. Compromising on quality can lead to detrimental impacts on both speed and cost, ultimately affecting the successful development and marketing of new therapies.
Further, the quality lever sits the closest to the fulcrum, where every effort leads to the largest output. In other words, focusing on quality can yield significant benefits with less effort compared to the other variables, and prioritizing quality can have a disproportionately positive impact on the overall project.
This underscores the need to redefine and understand 'quality' not just as product excellence but as a holistic concept encompassing process, partnership, and performance. Maintaining high-quality standards is not just a regulatory requirement but a business imperative. It's about ensuring the integrity of the entire development and manufacturing process, which ultimately reflects on the efficacy and safety of the therapies provided to patients.
This underscores the need to redefine and understand 'quality' not just as product excellence but as a holistic concept encompassing process, partnership, and performance. Maintaining high-quality standards is not just a regulatory requirement but a business imperative. It's about ensuring the integrity of the entire development and manufacturing process, which ultimately reflects on the efficacy and safety of the therapies provided to patients.
What is quality in CDMO partnerships?
When we shift our focus to CDMO partnerships, 'quality' takes on a broader dimension. It's no longer confined to the end product but extends to how CDMOs and pharma companies collaborate. The question then arises: what defines quality in these partnerships? Thermo Fisher Scientific recently convened a focus group of high-performing pharma partners to find out.
The group identified the following criteria that collectively form the backbone of quality in CDMO partnerships, moving the focus from making products to fostering excellence in every interaction and process.
- Supply robustness: A reflection of reliability and consistency in product delivery
- Deviation rates and complaints: A measure of operational excellence and response efficiency
- Resolution times: The ability to address and resolve issues promptly
- CAPA effectiveness: Competence in implementing corrective and preventive actions
- Regulatory compliance: Mastery in navigating health authority regulations
- Workforce stability: The retention of a skilled, experienced, and motivated team
- Communication: The establishment of transparent, ongoing dialogues
- Business reliability: Consistent and predictable business operations
Together, these defining characteristics provide a comprehensive framework for assessing and achieving quality in CDMO partnerships, above and beyond the traditional metrics of product quality. By understanding and embracing these eight criteria, pharmaceutical companies and CDMOs can forge partnerships that embody the true essence of quality, driving innovation and efficiency in the development of new therapies.