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Delivering Scalable Manufacturing Solutions
Your project is always a priority at Serán! Serán’s facilities provide flexible unit operations and adaptable suites to accommodate the unique needs of every program. Our ability to adjust to program volumes and flex with demands gives you peace of mind knowing milestones and timelines will always be met. Serán’s platform technologies, including our industry leading “right from the start” development paradigm results in smooth transition, validation, and tech transfer of your product from development to commercial. Our modular approach along with exceptional quality standards will get your drug product onto the market quickly.
By maximizing the value of early-stage data, we streamline:
- Identification and control of Critical Quality Attributes (CQAs)
- Process Validation and Execution of Process Performance Qualification (PPQ)
- Preparation for successful commercial launch
Lifecycle-Based Process Validation
Serán executes all Process Validation activities in alignment with the lifecycle principles defined by regulatory agencies such as the FDA and EMA.
Our Approach Ensures:
- Manufacturing scalability and flexibility as required for each unique product
- Compliance with global regulatory expectations
- Early identification and mitigation of risks that could delay approval
Serán's Commercial Manufacturing Capabilities
Technical & Regulatory Support
- Process validation (Stage 1–3)
- PPQ planning, execution, and final reporting
- Formulation process analytical risk assessment
- Regulatory strategy and submission support
- Analytical method transfer and validation
- Method lifecycle management
Solid Dosage Forms
- Tablets, capsules, powders
- Powders for Inhalation
- Clinical-to-commercial scale-up
- Commercial production at flexible volumes, including small scale commercial manufacturing
- Specialized delivery formats
Advanced Manufacturing Technologies
- Spray drying for solubility enhancement
- Wet and dry granulation
- Customized formulation design for bioavailability optimization
- Bottle and blister packaging
- Serialization for global compliance
- Humidity-controlled and high-containment packaging
- Flexible packaging solutions for various markets
Additional Capabilities
- Hot melt extrusion
- Particle engineering and micronization
- Nano-milling
Adjacent ~48,000 ft2 warehouse facilities completed in May, 2025, enable advanced materials management, packaging, labeling, and other supporting functions.
Serán supports pharmaceutical innovators through every stage of the product lifecycle—from early development to full-scale commercial manufacturing. Our integrated capabilities ensure speed, reliability, and regulatory confidence throughout your product’s journey.
