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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
Technology Transfer
Technology transfer is a critical step in bringing pharmaceutical products to market. This process requires detailed planning, cross-functional coordination, and regulatory expertise to ensure seamless integration of processes from formulation development to commercial production.
At Serán, our experienced teams manage every phase of the technology transfer process while ensuring regulatory compliance and accelerating time to market.
As clinical supply demands increase, process scale-up and appropriate control strategies must be implemented to ensure process capability and manufacturability. Once unit operations are defined, technology transfer can proceed – demonstrating reproducible performance in a cGMP-compliant setting.
Technology transfer refers to the transfer of processes, knowledge, and documentation between development and commercial production (or between different commercial sites). This intricate process demands comprehensive planning and an experienced team to develop, scale, and validate the processes and control strategies to support commercial production of the drug product. It is imperative that there is adequate regulatory, analytical and quality support to meet this goal. The complexities of technology transfer, particularly when transitioning between different companies, can pose significant challenges.
Serán’s teams possess a deep understanding of the technology transfer process and regulatory requirements to manage program milestones and uphold product delivery timelines. We begin early in the development phase by identifying and defining the critical quality attributes to guide all efforts. Once a process is defined, a detailed analysis is undertaken to determine the critical process parameters that enable process validation. We target to reduce the required materials and time to develop this process knowledge by leveraging scientific first principles and process modeling wherever possible.Serán's project management team is engaged with all stakeholders even before the project is signed. Clients and internal teams will have a thorough understanding of project requirements, goals, and deliverables, right from the start. The project manager will develop a comprehensive scope statement outlining the project's boundaries to ensure alignment on expectations and capabilities.
Serán's team uses agile processes to manage scope changes effectively throughout the project lifecycle, ensuring modifications are documented, approved, and communicated to relevant stakeholders.
Process scale-up often occurs simultaneously with process validation activities. Successful scale-up requires a risk-based approach and rigorous planning to best identify the process conditions and appropriate control strategies for scale-dependent variables. Leveraging scientific first principles and appropriate process models, we target to reduce the resources required for scale-up activities while maintaining confidence in production scale manufacturing quality.
At Serán, we support programs through every stage of drug development and formulation, catering to both small and large projects using a variety of complex drug substances. Our proven track record includes comprehensive containment ensuring the safe production of potent active pharmaceutical ingredients (up to OEB4 compounds), underscoring our commitment to operational safety and quality.
FUTURE Expanded Commercial Manufacturing & Packaging Solutions for Oral Solid Dosage Form
(upon opening of expanded commercial site Q2-2027)
Serán’s 50,000 ft2 greenfield commercial pharmaceutical manufacturing facility slated for operation Q2, 2027 will support advanced process and formulations to produce non-sterile solid dose commercial products.
Serán's project management team is engaged with all stakeholders even before the project is signed. Clients and internal teams will have a thorough understanding of project requirements, goals, and deliverables, right from the start. The project manager will develop a comprehensive scope statement outlining the project's boundaries to ensure alignment on expectations and capabilities.
Serán's team uses agile processes to manage scope changes effectively throughout the project lifecycle, ensuring modifications are documented, approved, and communicated to relevant stakeholders.
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.
