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OVERVIEW

����ɫ��ӰƬ Benefits      ����ɫ��ӰƬ Services

����ɫ��ӰƬ offers world-class services for the development and manufacturing of unit and bi dose nasal spray products out of the Morrisville/RTP, NC, facility. The site is equipped with industry-leading equipment with technology and capacity to support the growing interest in the nasal route of delivery, which offers potential as an alternative route for the delivery of systemic drugs, rescue therapies, vaccines, and nose-to-brain drug administration.

����ɫ��ӰƬ’s center of excellence for nasal drug development, has supported numerous nasal programs from early formulation, clinical and commercial production for more than 20 years. The 186,000-square-foot facility also provides comprehensive services for analytical services, biologics, supporting small and large molecule projects. With industry-recognized experts, ����ɫ��ӰƬ can help transform your nasal program into a successful treatment for you and your patients.

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CATALENT BENEFITS

• Comprehensive services that can help accelerate and simplify your development projects into the clinic, thru CMC/IND process and thru to a successful launch
  • Extensive experience with combination drug product development
  • Unit-Dose, Bi-Dose and Multi-Dose filling and assembly capabilities within environmentally controlled areas
  • Dosage form selection and technology assessment
  • Formulation development and analytical testing
  • Seamless Clinical product development to Commercial-scale manufacturing
  • Track record of regulatory success around the globe
  • Full spectrum project management and regulatory service capabilities
  • Clinical Supply services within the ����ɫ��ӰƬ network to support your clinical trial material requirements
  • Global network supporting all your program requirements

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CATALENT SERVICES

• Nasal Product Development
  • Formulation development, selection and optimization
  • Spray Characterization Studies (Device Reliability, Device Functionality)
  • Spray Characterization Method Development and Validation
  • Analytical and Microbiological method development and Validation
  • Nasal Device and Container selection
  • In-vitro bioequivalence testing
  • Extractables and leachable studies
  • cGMP compliance
• Laboratory Services
  • Analytical, Spray Characterization and Microbiological release testing
  • Spray Characterization release including Droplet Size Distribution, Spray Pattern, Plume Geometry and others
  • Microbiological services including microbial limits testing and endotoxin
  • Drug and delivery assays
  • Stability studies (ICH and custom conditions)
  • Structural elucidation of drug-related impurities and degradation products
• Clinical and commercial manufacturing
  • Clinical manufacturing supporting any stage within the product development cycle, along with flawless transfer of existing commercial product
    • Class 10,000 space / ISO 7
    • Potent compound handling capabilities
    • DEA-controlled substances licenses (Schedule III – IV)
    • Biologic compound handling capabilities
    • Flexible manufacturing and warehouse space
    • Customized facilities built to suit
    • Preservative-free, low-bioburden options available
    • “Roll in – roll out” equipment and processes
    • In-House Manufacturing Validation support (Equipment Qualification, IOQ, PQ, Process Validation and Cleaning Validation)