Many recognized drug development challenges are impacting oral solid dose (OSD) manufacturing. Most notably, the ever more complex nature of new molecules that are frequently affected by difficulties related to their bioavailability, formulation, stability, manufacturability, and scalability. At a time when the pharmaceutical industry is already under pressure to reduce development timelines and the associated costs, many developers are choosing to unload some of the responsibility related to manufacturing OSDs by using the services of contract development and manufacturing organizations (CDMOs). These providers are not only bringing expertise to the table in the manufacturing of OSDs, but also offer the benefits of access to new technologies, formulation ideas and other processing innovations.
The Popularity of OSDs
Most medicines, from over-the-counter treatments to prescription drugs, are taken by mouth in the form of tablets or capsules. The convenience, flexibility, cost-effectiveness, and patient-friendly nature of OSDs, especially among the pediatric and geriatric populations, are just some of the reasons why these dosage forms have stood the test of time. As well as being relatively simple to package, OSD forms offer increased chemical and physical stability.1
They can also bring the opportunity to extend product lifecycles and leverage growth potential, with many developers employing various lifecycle management patent strategies, including the development of new drug formulations, such as extended, controlled, or rapid release formulations. These innovations are making it possible for OSDs to achieve enhanced bioavailability. At the same time, they are helping to improve the patient experience and, consequently, driving better compliance to dosing regimens.
The global OSD market is expected to grow from $493 billion in 2017 to $926 billion by the end of 2027. This translates to a CAGR of 6.5%.1 More complex active pharmaceutical ingredients (APIs), different chemistries, smaller batches, advancing drug delivery technologies, as well as the introduction of continuous processing, are all adding to operational challenges for drug development teams. This is helping to fuel growth in the outsourcing market, with many developers now seeing CDMO partnerships as a vital component of their strategy.
OSD Outsourcing Market Drivers
Growth in the OSD outsourcing market may be attributed to three market drivers.
- Customers with high volume products are increasingly looking for an improved set-up from a total cost of supply point of view. While in the past developers would typically only consider the total cost of contract manufacturing, they are now considering other factors, such as the location of manufacturing and the potential for this to cause issues and slow down the supply chain.
- The requirement for more complex manufacturing processes is leaving many developers struggling to find the right technical set-up that is manageable from a cost standpoint. CDMOs that can offer a broad range of service and capabilities can help to simplify their supply chain.
- More small/virtual pharmaceutical companies are developing drugs that they do not intend on manufacturing themselves. Instead preferring to choose to partner with CDMOs that can take responsibility for development from the start.
The Rewards of Outsourcing
While OSD forms may have a long history of successful use, their development and manufacture still presents a complex endeavor. Outsourcing can provide an answer to streamline development processes and achieve more flexible manufacturing, while reducing capital costs and gaining access to capacity and capabilities. It also opens the door to a broad pool of expertise, which can help mitigate risk for developers.
Working with a CDMO minimizes the need for in-house resources. Drug developers can take advantage of specialized processing technologies for the manufacture of controlled release products, as well as the capability to produce combination products with several APIs.
CDMO selection should be based on an organization’s strong reputation in the industry. Developers ideally want to be looking at those providers that have a track-record for on-time delivery, as well as those that can deliver value for money through an attractive total cost of supply. The quality of relationships is also important in developing a collaborative partnership. Understanding how a CDMO will manage a pragmatic communication network and build regular dialogue with the development team should also form a key part of the selection process.
To ensure a smooth transition from development to commercialization, pharma companies will want to consider whether a CDMOs capabilities adequately match with their late stage requirements. It may be preferential to select a CDMO that can support the entire lifecycle and scale formulations from the laboratory to GMP clinical and commercial manufacturing. This can remove the risk, time and costs associated with technology transfer, as well as the requirement to manage multiple vendors. The robustness of manufacturing processes, capacity, trouble-shooting expertise, and access to global resources are also key attributes that should be considered a priority.
It is also important to understand a CDMO’s ability to achieve fast turnaround times while maintaining high quality. A thorough interrogation of the internal systems, processes, and procedures that a CDMO has in place is needed to ensure that project milestones will be met.
A reliable CDMO should demonstrate a good understanding of a product. This will include how a drug substance behaves during processing, such as its solubility in solvents and buffer systems, compatibility with excipients, stability under various physiological conditions, solid-state characteristics, and physiochemical properties. This understanding will be crucial in ensuring the right delivery system is identified and the optimal drug formulation developed. With today’s more complex compounds being prone to poor solubility, identifying the right formulation solutions which are faster to scale-up and offer a reduced likelihood of failure at the latter stages is vital in ensuring that a product reaches commercial manufacture.
Finally, complex projects will always present technical challenges and their own unique obstacles. Steps should be taken to identify a CDMO partner that can demonstrate experience of navigating difficult manufacturing projects. Being able to identify areas where problems are likely to arise will be essential to achieving success.
Conclusion
The dominance of OSD products in the pharmaceutical industry shows no signs of slowing down, with developers continuing to invest significant R&D expenditure toward more effective and patient-friendly solid forms. As increasingly complex molecules continue to drive demand for more diverse technical requirements and supply chain needs, outsourcing is becoming a crucial component in ensuring these products reach commercial manufacture in the most efficient way possible.
CDMOs have become a vital part of the OSD drug development and manufacturing process with most small and medium-sized enterprises (SMEs) and an increasing number of big pharma relying on their services. Providers that have the ability to work on a project from early development through to commercial manufacturing are able to gain a solid understanding of the OSD product being developed and are better equipped to handle any challenges that may arise during a project. As a result, an end-to-end service offering delivers an efficient manufacturing process and can improve supply chain efficiency.
References
- https://www.futuremarketinsights.com/reports/oral-solid-dosage-pharmaceuticalformulation-market
Author Biography
Erik Haeffler is the Vice President of Manufacturing Services and the Head of Sustainability at Recipharm. He is responsible for the Group’s sustainability work, as well as its focus on operational and commercial excellence. As part of his role, Erik is continuously developing a model for working with multi-site projects and is accountable for operations development across the company, including elements such as project management resources, corporate IS and project/product sourcing decisions.