Inhalation

INH0824

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This section provides information that may be useful in research and development or manufacturing. Content is provided by the companies listed. No endorsement or preference is intended. This section provides information that may be useful in research and development or manufacturing. Content is provided by the companies listed. No endorsement or preference is intended. SPECIAL SECTION Particle Manufacturing This section of Inhalation provides information that may be useful in research and development or manufacturing. Content is provided by the companies listed. No endorsement or preference is intended. Inhalation August 2024 31 Early development through commercial- scale manufacturing With 30+ years in pulmonary and nasal develop- ment and manufacturing, Catalent has experience in selecting the right particle technology to manufacture formulations with the appropriate product quality attributes for pulmonary and nasal delivery, tailored to the target dose, device type and API properties. Catalent has lab- to commercial-scale spray drying and jet milling to produce inhaled or nasal particles, as well as expertise in carrier-free or carrier-based pow- ders for encapsulation and nasal powder device filling. Catalent has the largest CDMO capacity in pharma- ceutical spray dryers designed for inhaled powders and nasal powder capabilities, with unrivaled experience in scaling up and commercializing inhaled products. Catalent Inhalation US: +1 888 SOLUTION (765-8846) solutions@catalent.com catalent.com Spray-dried biologics for pulmonary delivery For more than 20 years, Lonza Small Molecules has provided service offerings for spray-drying of biolog- ics, such as monoclonal antibodies (mAbs), oligonu- cleotides and peptides. In response to the growth of biologics in the drug development pipeline, Lonza now offers spray-drying of proteins for pulmonary delivery. e new offering provides clinical and com- mercial manufacturing services at a kilogram scale from Lonza's Bend, Oregon, US site, home to Lonza's Center of Excellence for respiratory delivery. Please contact us for more information. Lonza Small Molecules US: +1 813 286-0404 small.molecules@lonza.com www.lonza.com Particle engineering services Particle engineering is being used increasingly in drug development, particularly for complex dosage forms such as OINDPs, where deposition in the smaller air- ways is key to efficacy. Particle engineering can offer many advantages in terms of tailoring the particle size for targeted delivery, as well as offering a more con- trolled manufacturing process, which is also suitable for the formulation of biologics. Intertek is an expert in the spray drying of small and large molecules for respiratory products and has partnerships in place that support other particle engineering approaches, such as anti-solvent precipitation. Intertek Pharmaceutical Services UK: +44 1763 261648 bd.melbourn@intertek.com www.intertek.com

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