Companies operating in the pharmaceutical and biotech sectors must evaluate a range of critical factors prior to partnering with a contract development and manufacturing organization (CDMO).
Selecting and working with the right CDMO can significantly impact drug development projects’ chances of success, so it is essential that companies be well-informed before committing. This article features a comprehensive guide to understanding these key considerations.
Understanding specific needs
Any company looking to work with a CDMO should begin by defining its own product’s development requirements. For example, a company may be in preclinical, clinical, or commercial phase. It may also be prepared to engage an inexpensive CDMO for initial work and accept additional costs and time for tech transfer at a later phase.
Some projects require comprehensive end-to-end services, while others would benefit from support in specific areas, such as formulation or scaling up production.
Many CDMOs specialize in specific stages of development. Clearly identifying a project's stage and the services required allows companies to align their needs with a CDMO that offers complementary expertise.
This is an important consideration because a mismatch between a company’s needs and the CDMO’s capabilities can result in cost overruns, delays, and even regulatory setbacks. Precise alignment ultimately saves both time and money.
Evaluating experience and specialization
Not every CDMO will have equal experience across every dosage form, molecule type, and therapeutic area. It is important to thoroughly explore a potential CDMO’s portfolio and look for case studies or references related to the type of drug to be developed.
If a CDMO has successfully navigated projects involving similar drugs, it is much more likely to be able to effectively manage a project’s unique challenges.
Regulatory experience is also essential. The CDMO should have a track record of working with the EMA, FDA, or other regulatory bodies in a company’s target markets. It is also important that the CDMO is familiar with relevant regulatory frameworks to efficiently navigate compliance.
Scalability of operations
A drug’s production requirements tend to change as it moves through development stages, so it is important that the CDMO is able to scale from clinical trial production to full commercial manufacturing. With this in mind, it is also important to evaluate a CDMO’s capacity to accommodate increased production volumes while maintaining quality standards.
Companies should inquire about a potential CDMO’s manufacturing facilities and equipment, ensuring that it offers the capacity and flexibility to adjust to any potential production increases.
A good CDMO will employ scalable technologies that can help streamline the process, such as leveraging single-use systems in biologics. If a CDMO is unable to scale production in line with its client’s needs, launches could be delayed, and costs could increase, particularly during critical phases like commercial manufacturing.
Companies looking for less expensive options may opt to work with an early-phase CDMO that focuses on early-stage drug development, including preclinical and Phase I/II clinical trials.
Early-phase CDMOs tend to be lower cost because these CDMOs do not require the expensive infrastructure required for large-scale commercial production. Their procedures are also simple, because the testing of safety and efficacy is their primary concern.
Early-phase CDMOs can deliver more rapid timelines that lower overhead, though technology transfer costs are incurred when advancements in the drug necessitate the expertise of a late-phase CDMO.
These additional costs may be worth accepting, however, because late-phase CDMOs can often offer specialist knowledge around topics like mass production and distribution. The technology transfer process can also help companies update their small, experimental batches into consistent production capable of delivering higher volumes.
Regulatory compliance and quality standards
Quality control is non-negotiable in drug manufacturing, so it is important that a CDMO adheres to good manufacturing practices (GMP) and that it successfully passes regular inspections by regulatory agencies like the FDA and EMA.
Companies should investigate a potential CDMO’s compliance history in order to ensure that it meets stringent quality management systems (QMS).
Transparency in quality processes is also key, including how a potential CDMO manages inspections and audits. The CDMO should have a demonstrable history of timely regulatory approvals, and warning letters or compliance issues should be highlighted and thoroughly considered.
Communication and project management
Effective communication is the foundation of a successful partnership. Clear, consistent, and transparent communication is key to managing expectations and timelines while avoiding potential setbacks.
A CDMO should provide a dedicated project manager who will serve as a primary contact throughout the project, ensuring transparency and keeping the company informed of key milestones, updates, and challenges.
A small biotech should expect a CDMO to treat its project with the same care as the projects of big pharma clients in its portfolio.
Location and supply chain capabilities
Geographical proximity has a major impact on logistics and project management, so companies should consider the CDMO’s location in relation to their own operations, particularly if the project in question involves global markets.
A good CDMO should understand specific regional regulations where a product will be marketed and be able to manage cross-border supply chains without delays. A CDMO with robust global capabilities can help streamline issues such as shipping times, customs clearance, and differences in regulatory jurisdictions.
Cost transparency and flexibility
A CDMO’s pricing model should be transparent and clear. Some CDMOs work with opaque pricing structures, charging hidden fees for services like regulatory submissions, quality testing, or material procurement. It is important to request detailed cost breakdowns prior to engaging a CDMO, ensuring that the contract accounts for any potential changes in project scope.
A CDMO should also be flexible enough to manage unforeseen issues without major budget implications. It should also be able to adjust costs if the project needs to pivot or expand.
Innovation and technological capabilities
CDMOs may be able to improve efficiency and lower costs by investing in innovative technologies and leveraging cutting-edge methods and technology. This can offer a range of advantages, but a company should also confirm whether or not these organizations will cover the costs of implementing these technologies or if the client must cover this cost.
A good CDMO will also leverage automation or data-driven analytics to improve manufacturing processes. These technologies can significantly reduce human error, streamline operations, and offer faster turnaround times.
Cultural fit and partnership philosophy
Cultural fit should never be overlooked because a company’s partnership with a CDMO is a long-term engagement that can span years to decades. The CDMO should align with the company’s goals, values, and underlying way of working. A robust cultural fit leads to fewer disruptions and an overall smoother, more productive, long-term relationship.
Conclusion
Working with the right CDMO can essentially make or break a drug development project.
Considering the critical factors outlined here will allow companies to select a partner that meets their technical and regulatory requirements while aligning with their long-term goals.
DS Inpharmatics’ wide-ranging and comprehensive experience in guiding clients through these complex decisions ensures successful partnerships with CDMOs, streamlining the path to regulatory approval and commercial success.
Acknowledgments
Produced from materials originally authored by Meranda Parascandola from DSInpharmatics.
About Design Space InPharmatics LLC
DSI provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence.
Whether advocating CMC strategy, directing CMC operations, or developing CMC submission content that represents the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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