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PharmTech.com Trends in Formulation 2022 eBook Pharmaceutical Technology ® 9 exquisite target activity but which fails due to other attributes, such poor manufacturability or stability. "While the activity of your candidate at the target is a critical determinant of its therapeutic and market potential, it isn't the only one. There are many other attributes that need deep and comprehensive con- sideration—particle size, shape, structure, surface properties, and thermal stability, for example," Tiago states. These characteristics can impact behavior as diverse as reaction and dissolution, f lowability, com- pressibility, and efficacy, and because of their impact, these characteristics need consideration as early as possible in development. "In the case of protein-based therapeutics, stability considerations are particularly important. For ex- ample, if a protein is structurally unstable, it can un- dergo conformational changes that reduce binding and therapeutic efficacy. Similarly, colloidal insta- bility within the final formulation of a protein-based therapy can lead to protein aggregate formation, which could impact deliver y or even be immuno- genic," Tiago explains. With such a complex range of attributes to navigate, developers must, therefore, use complementary and orthogonal analytical technologies to provide a full understanding of their candidates. A helpful suite of tools could include dynamic light scattering for col- loidal stability evaluation, differential scanning cal- orimetry for structural stability measurements, and a host of other complimentary techniques, according to Tiago. Planning an orthogonal strategy is another challenge in and of itself, however. Considerations for an orthogonal strategy include: • W h ich i nst r uments a re best for measur i ng which attributes? • Which analyses are needed given the therapeu- tic modality in question? • How might these evaluated parameters then relate to each other or drive efficacy changes? Such considerations require a level of knowledge and expertise that spans multiple domains and is, as noted previously, in significantly shor t supply, Tiago emphasizes. Contract research organizations (CROs), for instance, have been stepping up to sup- port bio/pharmaceutical organizations to navigate these key questions. "Essentially, [CROs] are filling the industry void of specialized expertise and concentrating it in a man- ner that can best support drug developers. Analytical instrument providers are also helping here, provid- ing timely and extensive advice on optimal study de- sign and being open about the need for orthogonal- ity in early screening. This combination, ultimately, creates a more collaborative environment—one that is carving a smoother, more strategic path to drug discovery success," Tiago concludes. ■ Development INNOVATE | FORMULATE | CREATE Topical Aerosol Foams, Sprays, and Bag on Valve Dispensing; We're the Best in Consumer Healthcare. Whether its Branded Rx, Medical Device, or OTC manufacturing and fi lling, no one can match our speed, capabilities, and knowhow. So, bring us your pressurized package challenge. We'd love to help. Turnkey Concept-to-Consumer CDMO Solutions. Contact us today: (727) 373-3970 websales@formsol.com | FormulatedSolutions.com SCAN ME