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cGMP Manufacturing
We provide clinical manufacturing capabilities for a broad range of oral solid dosage forms including unit operations in particle size reduction, spray-dried dispersions, tablet compression, tablet coating, encapsulation, and clinical packaging and labeling. If you are developing a first-in-human asset, or looking to expand to later stage clinical trials, we have a variety of phase-appropriate processes to rapidly advance your drug to the clinic.
Serán’s cGMP facility is designed with highly configurable cleanrooms capable of ISO 8 classification, to efficiently support a wide variety of manufacturing operations. Our strict focus on sanitization and microbial monitoring procedures ensures a safe and clean operating environment for your compound and trial participants. Serán’s cGMP activities are managed under a mature and compliant quality assurance system. Our QA team will work with you to ensure your project and regulatory requirements are met, while maintaining flexibility within your specific phase of development.
Our cGMP capabilities include spray drying, hot melt extrusion, blending, milling, granulation, encapsulation, tablet compression, tablet coating, and clinical packaging and labeling. If you are developing a clinical asset, we have a variety of phase-appropriate processes to rapidly advance your drug to the clinic.
Capabilities
- Support all clinical manufacturing phase PhI – III
- ISO 8 Classification
- On-time delivery track record
- Dynamic manufacturing, adaptable environment
- Formal controls, robust and mature quality systems
- Process validation
- Extensive management and operational experience
- Leverage manufacturing flexibility to enable higher speed to clinic
- Commitment to quality and data integrity
- Continuous improvement
- Inspection readiness, audit
- Regulatory guidance
Technologies
- Oral solids
- Spray drying
- Tablet compression
- Dry granulation (roller compaction)
- Tablet coating
- Capsule filling (granules, powder)
- Pediatric dose forms
- Hot melt extrusion
- Spray drying
- Direct blend
- Micronizing: Jet and nano milling
- Primary packaging & labeling in a variety of formats, bulk, bottle
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