The formulation, development and manufacturing of oral, peptide-based drugs is a tricky business. Enteris BioPharma has the capabilities and expertise to meet an array of manufacturing needs for pharmaceutical partners using our best-in-class Peptelligence® drug delivery technology to develop oral formulations of peptide and certain small molecule-based injectable therapeutics.
Our CDMO operations are housed within a growing 32,000-square foot, FDA inspected and GMP compliant facility in Boonton, NJ. We are equipped to ensure high-quality production of GMP clinical trial material, analytical development and stability testing, with a proven enteric-coated tablet formulation that is scalable and readily transferable.
Enteris currently supports our partners’ research and development needs from feasibility through Phase 2. However, with the support of our parent company, SWK Holdings, Enteris expects to soon enhance our manufacturing capabilities to enable Phase 3 and commercial-level production.
Interested in hearing more about Enteris’ CDMO offerings? Contact us today to learn how you can partner with Enteris BioPharma.
CLINICAL TRIAL MANUFACTURING OFFERINGS
GMP Manufacture of Tablets and Capsules
- cGMP manufacturing facility
- Provision of clinical trial materials for US, EU, and globally
- Equipped to manufacture and package tablets and capsules from bench scale to Phase 2 clinical trial materials
- Capable of working with low dose / high potency APIs
- Experience with technology transfer and scale-up with multiple CMOs
- Analytical assay development and validation
- Evolutionary approach: phase-appropriate through NDA quality validations
- Submission quality reports
- On-site in-process control, release and stability testing
- Full support through analytical method transfer
- Systems compliant with FDA, EMA and ICH
- Customer focused, providing real time feedback on all quality related issues
- Full project participation:
- Process development → batch record design → GMP manufacture
- Manufacturing oversight through concurrent batch record review
- Vendor auditing and qualification program