MORRISVILLE, USA

The Morrisville (MSV) facility is Catalent’s center-of-excellence for standalone analytical services supporting pharmaceuticals, biologics (protein, cell and therapy, and vaccines), inhalation (nasal and dry powder inhaler), drug product/substance and in-process samples. The site supports comprehensive analytical services catering to the needs of customers from discovery through to commercial phase programs, while ensuring the highest safety and efficacy standards in line with the regulatory and compliance industry requirements.

The facility is also a major site for Catalent’s Inhalation business, with end-to-end development through commercial manufacturing services for nasal products. It also offers full scale product development services for pulmonary delivery including dry powder inhalation (DPI) and nebulized products and clinical-scale manufacturing for DPIs including state of the art equipment such a Procept Spray Drier, GEA blenders and a Harro Hofliger drum lab. The facility offers the latest in high-speed commercial-scale nasal manufacturing (unit dose, bi dose and multidose) as well as flexible fill lines for clinical-scale and small batch production. The side-by-side nature of our analytical and inhalation teams yield particularly robust inhalation formulation and development services.

The facility is conveniently located approximately 10 minutes from the Raleigh-Durham International Airport (RDU).

Size: 186,406 ft²

CAPABILITIES:

• Small Molecule Analytical Services
  • Method development and phase-appropriate validation
  • Dissolution for oral solid dose
  • Elemental impurities
  • Physical testing
  • Reference standard characterization and qualifications
  • Cannabinoids and natural products testing
  • Nitrosamines
  • In-use stability studies
  • Compendial testing
  • NMR analysis
  • Solid-State characterization services
  • Microbiological and environmental monitoring services
  • Extractables and leachables
  • Release and ICH stability testing
  • Stability storage (all zones)
• Biologics Analytical Services
  • Method development, phase-appropriate validation, and testing
  • Compendial testing per USP/NF, EP, BP, JP, etc.
  • Stability studies/storage
  • Cell bank establishment and storage
  • Bioassays
  • Impurities testing
  • Extended characterization
  • Reference standard aliquoting and qualification
  • Speciality studies (forced degradation, charge variant, etc.)
  • Microbiological and environmental monitoring services
  • Drug metabolism (PK/PD)
  • Immunogenicity and neutralizing antibody testing
• Inhalation Services – Nasal
  • Formulation development, optimization and scale-up
  • Product and process development
  • Spray characterization development and validation
  • Device compatibility, selection, reliability. and functional testing
  • Unit-dose, Bi-dose and preserved Multi-dose liquid nasal products
  • Nebulized solutions, suspensions or emulsions
  • Unit-dose nasal powder
  • Clinical to commercial scale filling and assembly
  • Finished Product Testing
• Dry Powder Inhalers (DPI)
  • Preformulation and dose form development
  • Pilot through clinical scale spray drying
  • Drum-based capsule filling
  • DPI device evaluation, selection and testing

FEATURED TECHNOLOGIES:

• OptiForm^®  Solution Suite
• Optiform® API Technology Solid State Chemistry Services

ACCREDITATIONS

• FDA Approved

SALES INQUIRIES

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CAREERS

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