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36 Pharmaceutical Technology ® Trends in Formulation eBook September 2024 PharmTech.com Industry trends Keeping the patient in mind The industry trend of developing patient-centric treat- ments means that the formulation of a drug must take the end patient even more into consideration. "In contrast to historical approaches of developing a drug and then re- quiring patients to adapt as needed in order to adhere to the delivery mechanism and dosing regimen, patient cen- tricity is an approach that puts the patient's needs and pref- erences at the core of the development process," says Patil. "For example, orally disintegrating tablets, which dissolve quickly in the mouth without the need for water, were de- veloped to help patients who had difficulty swallowing, such as those with certain neurological conditions or the elderly. Similarly, wearable insulin devices provide con- tinuous glucose monitoring and insulin delivery, which reduces the need for multiple daily injections. Finally, one recent advancement has been the development of digital pills embedded with ingestible sensors that can track when and if the patient has taken their medication. This information can then be relayed to healthcare providers Utilizing Outsourcing Partners for Formulation Advances Innovation is moving fast in drug development and formulation. To get a perspective on how contract de- velopment and manufacturing organizations (CDMOs) can assist in drug product formulation, Pharmaceutical Technology® spoke with Sibaji Biswas, executive direc- tor and chief financial officer at Syngene International; Bernard Sagaert, CEO and Phil Challis, SVP Manufac- turing at etherna; Vincent Levet, PhD, director, Formu- lation Development and Production at Ardena; Vinay Patil, Product Development manager at Sharp Ser- vices; Hanns-Christian Mahler, CEO and board mem- ber at ten23 health; and Gary Watts, senior manager in Analytics, Abzena. PharmTech: What role does/should an outsourcing partner play in drug formulation? Biswas (Syngene International): Outsourcing partners are crucial in drug formulation, especially through deployment of phase-appropriate development processes. This approach customizes development to each phase, keeping a balance between speed and quality processes required. For instance, we aim to move quickly from preclinical to phase [II]A with early- phase quality systems. Then, as we progress to later phases ([II]B, [III], NDA [new drug application], and commercialization), more controlled quality systems are required. Sagaert and Challis (etherna): As we see it in our space, having the integrated knowledge and know-how not only in formulation of lipid nanoparticles (LNPs) but also in RNA manufacture, process technologies are key. The formulation does not stand alone and is not the only driver to get to a successful product you need to be able to leverage the knowledge of all product components. Having access to all of these in one player, where experienced scientists working on all these areas talk to each other and find solutions makes the difference. This is how drug discovery companies tackling outsourcing should consider development of a therapeutic product based on RNA-LNP technologies. Levet (Ardena): Outsourcing partners like CDMOs are concentrators of experience, having dealt with multiple compounds in various phases. This is particularly beneficial for companies that may have limited internal experience and sometimes just a single compound in their portfolio. Patil (Sharp Services): The role of your outsourcing partner should be based on your own knowledge of formulation and the compound you want to bring to market. Most importantly, your outsourcing partner should, from day one, work side-by-side with you to understand your vision for your product, and then execute to bring that vision to life. Mahler (ten23 health): Outsourcing partners may be best suited to address specific formulation challenges. They can focus on a given technology and look 'deep', whereas a specific pharmaceutical company (the 'sponsor') may need to look 'broad' (across a portfolio), which may in some cases not allow sufficient resources (example: facility utilization) for specific in-depth technology expertise. An outsourcing partner which then not only has 'formulation knowhow' but can combine that with 'manufacturing knowhow' and actual manufacturing facilities, can best provide support for any pharmaceutical company. Such a combination of development and manufacturing allows the outsourcing partner to also ensure manufacturability, as discussed above. Watts (Abzena): The outsourcing partner should offer a broad range of formulation and manufacturing services that support a biopharmaceutical product throughout its entire lifecycle from the initial pre-formulation through to clinical trials and product launch. There should also be seamless technology transfer between the R&D scale research and manufacturing including buffer preparation and formulation protocols, TFF [Tangential Flow Filtration] methods, etc. Having access to a full suite of services enables clients to utilize a single organization for all their formulation and manufacturing requirements, which streamlines and de-risks the process and allows any experience and learnings to be shared across teams. This first-hand knowledge of the product can then be applied to rapidly solve any complex problems which may arise downstream.