Inhalation

INH0820

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Recent news about companies that support development of orally inhaled and nasal drug products (OINDPs), research and development related to COVID-19, and progress in the treatment of respiratory diseases, such as asthma, COPD and tuberculosis. 8 AUGUST 2020 Inhalation INDUSTRY NEWS Catalent to support manu- facture of two COVID-19 vaccine candidates SOMERSET, NEW JERSEY— Catalent has announced it will provide vial lling and packaging capacity to AstraZeneca PLC at Catalent's facility in Anagni, Italy and prepare for large-scale com- mercial supply of the University of Oxford's COVID-19 vaccine candidate, AZD1222, currently in clinical trials. Catalent is preparing for round-the-clock manufacturing to supply hundreds of millions of doses from August 2020 potentially through March 2022, should the product be approved by regulatory agencies. Catalent also announced it will collaborate with Moderna for large-scale, commercial fill-finish manufacturing of their COVID- 19 vaccine candidate (mRNA- 1273), using Catalent's biologics facility in Bloomington, Indiana. e company will provide for sta - ing for 24×7 manufacturing of an initial 100 million doses intended for the United States market, start- ing in the third quarter of 2020. The companies are in discussion regarding production of hundreds of millions of additional doses. In addition, Catalent will provide clinical supply services from its facilities in Philadelphia, Pennsyl- vania (including packaging, label- ing, storage and distribution) to support Moderna's Phase 3 clinical study of the mRNA-1273 vaccine. Experic and PCI Pharma to collaborate PHILADELPHIA, PENNSYL- V A N I A A N D C R A N B U R Y , NEW JERSEY—According to Business Wire, Experic, a contract manufacturing organization and pharmaceutical supply service com- pany will form a partnership with PCI Pharma Services, a pharmaceu- tical and biopharmaceutical global outsourcing solutions provider. Experic will provide PCI access to its low-dose powder lling capabil- ities for inhalation and other appli- cations and efficient transition of products from clinical- to commer- cial-scale manufacturing. PCI will give Experic access to its clinical and commercial supply chain capabili- ties and presence in Europe. RESPIRATORY MEDICINE NEWS Urgent appeal from ISAM supporting inhaled COVID-19 therapies NEW YORK, NEW YORK—A team of authors representing the ISAM Regulatory and Standard- ization Issues Networking Group has published an urgent appeal to clinical decision makers and governmental agencies to con- sider the inhaled route of admin- istration in COVID-19 therapies. ey support a highly collaborative approachbetween regulators and developers, supported by studies at the earliest opportunity involving patients and caregivers to deliver therapies that have a high probabil- ity of a favorable bene t/risk ratio. e appeal appeared in the Journal of Aerosol Medicine and Pulmonary w w w . m e r x i n . c o m i n f o @ m e r x i n . c o m W E M A K E T H E W O R L D H E A L T H I E R O N E B R E A T H A T A T I M E continued on page 31

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