Enteris offers Phase 1 & 2 clinical manufacturing services to support pharma companies developing Orally Inhaled and Nasal Products (OINDP) using Aptar Pharma's device platforms.

THIS INCLUDES

  • Highly Potent API (HPAPI) handling and containment
  • Extensive expertise in development and handling of biologics
  • Analytical method development, verification, qualification and validation for dry powder inhalers, nasal powders, and nasal spray formulations
  • cGMP manufacturing of nasal medicine clinical trial materials (CTM)
    • Including spray drying, freeze drying, powder post-processing and device filling and assembly
  • cGMP batch release and ICH stability studies
    • Including OINDP product performance testing
  • Semi-automated, commercially-representative device filling and assembly lines
  • Process development and validation for technology transfer to CMO

 

HIGHLIGHTS OF CAPABILITIES

  • CDMO intranasal product, inhalation powder CDMO,
    inhalation drug delivery CDMO
  • 32,000 sq ft cGMP facility in New Jersey, USA
  • State of the art, recently renovated facility dedicated to clinical manufacturing
  • Extensive experience in biologics, particularly peptides
  • Inhalation drug development, dry powder inhaler CMC,
    inhaled nasal product CMC
  • GMP manufacturing nasal spray, DPI dry powder, intranasal drug product, inhalation product testing
LEARN MORE ABOUT ENTERIS

Orally Inhaled and Nasal Drug Products - Clinical Manufacturing

Enteris offers Phase 1 & 2 clinical manufacturing services to support pharma companies developing Orally Inhaled and Nasal Products (OINDP) using Aptar Pharma's device platforms.

THIS INCLUDES

  • Highly Potent API (HPAPI) handling and containment
  • Extensive expertise in development and handling of biologics
  • Analytical method development, verification, qualification and validation for dry powder inhalers, nasal powders, and nasal spray formulations
  • cGMP manufacturing of nasal medicine clinical trial materials (CTM)
    • Including spray drying, freeze drying, powder post-processing and device filling and assembly
  • cGMP batch release and ICH stability studies
    • Including OINDP product performance testing
  • Semi-automated, commercially-representative device filling and assembly lines
  • Process development and validation for technology transfer to CMO

HIGHLIGHTS OF CAPABILITIES

  • CDMO intranasal product, inhalation powder CDMO, inhalation drug delivery CDMO
  • 32,000 sq ft cGMP facility in New Jersey, USA
  • State of the art, recently renovated facility dedicated to clinical manufacturing
  • Extensive experience in biologics, particularly peptides
  • Inhalation drug development, dry powder inhaler CMC,
    inhaled nasal product CMC
  • GMP manufacturing nasal spray, DPI dry powder, intranasal drug product, inhalation product testing
LEARN MORE ABOUT ENTERIS