Why outsourcing is key to bringing flexibility and capacity to the manufacture of oral solid dosage forms
The complexity of new molecules is fuelling the outsourcing of oral solid dosage (OSD) manufacture. Innovators are choosing to share the burden of challenges relating to bioavailability, formulation, stability, manufacturability and, not to mention, scalability. Industry pressures to reduce development times and costs, as well as increasing numbers of smaller drug developers now taking molecules to market, are spurring partnerships with contract development and manufacturing organisations (CDMOs).
There are many reasons why oral solid dosage forms remain popular, including their ease of manufacture, cost-effectiveness, and patient-friendly nature. Advances in drug delivery are now enabling these formulations to achieve better bioavailability through the adoption of novel drug delivery technologies, such as extended, controlled, and rapid release systems. From the patient perspective, these can offer inherent advantages in dose administration and can be formulated in varying dosage forms to increase compliance.
Today, many changes are occurring in oral solid dose manufacturing with different chemistries being used that require new approaches and the implementation of continuous processing. Demand is high for CDMOs that can bring both formulation expertise in this area, as well as flexible manufacturing capacity. Outsourcing not only serves to streamline development processes, but it can bring wider access to expertise, helping to mitigate risk. It also reduces the need for in-house resources and allows a developer’s team to focus on core R&D competencies.
In selecting a CDMO, developers should look for a clean compliance record, good supply service and a reputation for on-time delivery. Increasingly, developers are expecting CDMOs to take responsibility for project management. Being able to forge a strong, strategic relationship and build solid communication with a partner is becoming a more fundamental part of the outsourcing relationship; improving efficiencies and reducing costs cannot be achieved without dialogue and understanding between developer and supplier.
It is also critical to consider early on if a CDMO’s capabilities are compatible with a developer’s later stage requirements. This will be fundamental to achieving a seamless transition through the development phases into commercialisation. Many developers prefer to work with CDMOs that can scale formulations from the laboratory to GMP clinical and commercial manufacturing. CDMOs that offer these capabilities can help to eliminate the risk, time and cost associated with technology transfer.
Another key driver should be the CDMO’s capability to meet shorter timelines while maintaining a high level of quality. Therefore, developers should look to gain a good understanding of a CDMO’s internal systems, processes, and procedures.
Developers will also want to work with a CDMO that can offer a comprehensive understanding of their drug substance. They should understand how the substance behaves during processing, including its solubility in solvents and buffer systems, compatibility with excipients, stability under various physiological conditions, solid-state characteristics, and physiochemical properties. These details are essential in selecting the right delivery system and the development of an optimal drug formulation.
While oral solid dose products may seem outdated compared to new biopharmaceutical products, they continue to constitute a major share of all medicines. CDMOs that can offer developers expertise in formulation development and can achieve seamless scale-up and technology transfer for commercial manufacturing will provide a clear advantage in supporting the manufacture of complex oral solid dosage forms.
More information on Recipharm’s oral solid dose services can be found here.