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
Aptar Pharma's Unidose (UDS) Powder
Nasal Spray Device
Aptar Pharma's Unidose (UDS) Liquid
Nasal Spray Device
Aptar Pharma's Bidose (BDS) Liquid
Nasal Spray Device
Aptar Pharma's Dry Powder Inhaler
(DPI) Orbital™
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
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
Aptar Pharma's Unidose (UDS) Powder
Nasal Spray Device
Aptar Pharma's Unidose (UDS) Liquid
Nasal Spray Device
Aptar Pharma's Bidose (BDS) Liquid
Nasal Spray Device
Aptar Pharma's Dry Powder Inhaler
(DPI) Orbital™
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
