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© Copyright Inhalation catalent.com Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solu- tions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has the proven ex- pertise, superior technologies and fl exible solutions at the right scale to help ensure successful product development, launch, tech transfer and reliable global supply. Catalent has developed this expertise through helping partners of all sizes, from the smallest innovators to the largest of biopharmaceutical leaders, to advance thousands of molecules through each phase of development and on to com- mercial supply. We do this by arranging our expertise, capabilities, technologies, and capacity to provide services from specifi c, tailored program support to comprehensive, integrated solutions that are fast, fl exible, reliable and that help our partners reduce project risk. From injectable and inhaled to oral and consumer health, we have the passion to take your product to clinic and market. Technology Highlights With its expert services, Catalent drives faster, more effi cient de- velopment of differentiated and patient-preferred products with its advanced technology offerings including: • Autologous & Allogeneic Cell Therapies • Viral Vectors • GPEx ® Cell Line Engineering • SMARTag ® ADC Technology • Bioavailability enhancing technologies including RP Scherer ® Softgel, OptiShell ® Technology, Spray Dry Dispersions • Zydis ® Orally Disintegrating Technologies Integrated Solutions Catalent offers a number of integrat- ed solutions to accelerate clinical and commercial development: • OptiDose ® Design Solution helps determine optimal dose form for more successful treatments • OptiForm ® Solution Suite for rapid, optimized dose form development • OptiForm ® Total Supply accelerates drug candidates from development to clinical phase • OneXpress™ provides the fastest pathway from clinical development to commercial manufacturing • OneBio ® Suite, reduces timelines, risk and complexity for biopharmaceuticals from cell line development through clinical supply Catalent Inhalation Catalent leverages decades of expe- rience in the development, evalua- tion, and manufacture of inhalation products to advance and accelerate molecules from early development through commercial manufactur- ing. Catalent's operation integrates its knowledge and experience in preformulation sciences, formulation development, device evaluation/ selection, CMC, manufacturing, and product characterization to reliably deliver therapies across all common inhalation dosage forms: • Unit/Bi-Dose Nasal Sprays • Metered Dose Inhalers (MDIs) • Dry Powder Inhalers (DPIs) Table of Contents 4 INDUSTRY TREND: Examining the Emergence of Unit- & Bi-Dose Nasal Sprays 10 Resource Directory 11 Quality by design: Considerations for inhalation product development 16 Resource Directory 17 Why companies are looking for product development partners, how the process works, and what to look for in a CRO. 2 Catalent 14 Schoolhouse Road; Somerset, NJ 08873 tel: +1 888 765 8846 | e-mail: solutions@catalent.com | web: catalent.com