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Turning Complex Molecules Into Medicines
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Leveraging Advanced Formulation Technologies
Serán Bioscience, is a science-based CDMO that specializes in a variety of drug delivery and formulation approaches suited to optimizing bioavailability. Serán’s experienced formulation team works with its clients to identify an appropriate technology and formulation strategy to meet each program’s unique needs.
Serán takes a comprehensive approach to formulation design considering the physicochemical properties of the API, the target product profile, and each program’s objectives and constraints to develop scalable formulations using efficient and material-sparing approaches.
The Serán Advantage
- Foremost authority in developing complex molecules
- Spray drying, HME, milling, blends, granulation, coatings
- Scalable drug product design for tablets, capsules, solutions, PiB
- Highly customizable solutions
Capabilities and Technologies
- Technical expertise to tackle the most complex customer projects
- Tailored and customized approaches
- Decades of experience in spray drying, numerous patents for spray drying and formulation technologies
- Expertise in colloidal science for manufacturing of micro- and nanoparticles with enhanced performance characteristics
- Material sparing prototype screening for scalable drug product
- Pediatric formulation development
- PK/PD study design support and data analysis
- Technology transfer
- Modified release / controlled release formulation development
- Drug product intermediate development
- Tablets – IR, MR/CR, cosmetic or functional coatings, bilayer, fixed dose combinations
- Capsules
- Analytical method development
- Bioavailability enhancement using amorphous solid dispersions, produced by spray drying or hot-melt extrusion
- Dissolution-rate-enhancement using API micronization or wet bead nanomilling for particle suspensions
- Spray drying
- Hot melt extrusion
- Particle size reduction: Jet and nano- milling
- Direct blend, dry granulation / roller compaction, wet granulation
- Coating (cosmetic or function, pan and fluid bed)
- Tunable particle size for pulmonary targets in the lung
- High-concentration micro- or nano-particle suspensions of biologics or small molecules for sub-cutaneous delivery
- Quality and regulatory guidance, inspection readiness, audit
- Manufacturing process design & engineering
- cGMP manufacturing phase I-III
- On-time delivery track record