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
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