Contract Development and Manufacturing Organizations have become game-changers in the pharmaceutical industry. They offer a wide range of services, from drug development to commercial production, helping pharmaceutical companies bring new treatments to market faster and more efficiently. CDMOs have a significant influence on innovation in the pharmaceutical industry, gaining further relevance through their increasing technological expertise and know-how along the value chain. Their focus on technological advancements, particularly in novel modalities and continuous manufacturing, keeps them at the forefront of industry trends.
The Role of CDMOs in Drug Development
CDMOs play a crucial role in the biopharmaceutical industry by focusing on process development and manufacturing. They contribute significantly to producing biopharmaceuticals for various diseases, supporting the industry’s growth. CDMOs offer specialized expertise, established quality systems, and regulatory compliance knowledge, which has become increasingly important as biopharmaceutical companies concentrate their resources on drug discovery and development.
The emergence of CDMOs has paralleled the semiconductor industry’s horizontal division model, providing insights into key success factors for the biopharmaceutical CDMO industry. This model allows pharmaceutical companies to invest more in new drug discovery while relying on CDMOs for process development and manufacturing.
CDMOs have expanded their capabilities along three main axes: value chains within a modality, new modalities, and complementary service categories. This expansion enables CDMOs to offer swift manufacturing capacity allocation and secure long-term capacities for assets. As a result, CDMOs have become strong contributors to innovation in the pharmaceutical industry, gaining further relevance through their increasing technological expertise and know-how along the value chain.
Selecting the Right CDMO Partner
Choosing the right Contract Development and Manufacturing Organization (CDMO), like Mabion, is vital for pharmaceutical companies. A systematic approach is essential to make this critical decision. Most important factors to consider include quality, flexibility, speed, cost-effectiveness, and experience. Quality should be the top priority, as it directly impacts the final drug product’s safety and efficacy.
Flexibility is vital for CDMOs to adapt to various customer needs and quality management systems. Speed is another critical factor, as it affects the time-to-market for new drugs. While cost is significant, selecting the cheapest option may lead to long-term issues. Experience across various therapeutic modalities and delivery systems can be invaluable, especially for companies with limited resources.
To facilitate the selection process, companies can use tools such as a CDMO library, RFP templates, scoring templates, and information matrices. These tools help in creating a shortlist of potential partners, efficiently communicating requirements, and objectively evaluating proposals.
To learn more about CDMO services, visit Mabion‘s website to explore our offer.
References:
- Hideyuki Kurata, Tetsuya Ishino, Yasuhiro Ohshima,and Masafumi Yohda, CDMOs Play a Critical Role in the Biopharmaceutical Ecosystem, National Library of Medicine: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8978586/, access: 11.09.2024.
- CDMO Support: Catalyst for Success in Early Phase Drug Product Development and Manufacturing. PCI Pharma Services: https://pci.com/resources/cdmo-early-phase-drug-product-development-and-manufacturing/, access: 11.09.2024.
- Dr Isabelle Heiber, How CDMOs are leading innovation for pharmaceutical partners, EY Parthenon: https://www.ey.com/en_gl/insights/strategy/how-cdmo-companies-are-leading-innovation-for-pharmaceutical-partners, access: 11.09.2024.
- Jacob Bell, For CDMOs, continuous manufacturing isn’t an ‘if,’ but a ‘how’, Biopharma Dive: https://www.biopharmadive.com/news/cdmo-continuous-manufacturing-technology-pharma-drug-industry/532790/, access: 11.09.2024.
- Choosing A CDMO: Key Considerations, PCI Pharma Services: https://pci.com/resources/choosing-a-cdmo-key-considerations/, access: 11.09.2024.
- Maria Wik, MS, Useful Tools to Facilitate CDMO Selection Process for Biologics, Syner-G BioPharma Group: https://synergbiopharma.com/useful-tools-to-facilitate-cdmo-selection-process-for-biologics/, access: 11.09.2024.