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Commercial Manufacturing
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 and modular approach along with exceptional quality standards will get your drug product to market quickly.
Serán’s greenfield commercial pharmaceutical manufacturing facility slated for operation Q2, 2027 will support advanced process and formulations to produce non-sterile solid dose commercial products.
Capabilities include:
- Semi-continuous spray drying and secondary drying
- Twin-screw extrusion and wet granulation
- Advanced mixing/blending and dry granulation
- Multi-layer tableting and encapsulation
- Continuous tablet coating
- Integrated Analytical Lab Enables Rapid Results and Operational Support
- Bottle/Blister/Sachet packaging, labeling and serialization
Scalable Unit Operations
Custom manufacturing systems and systems from industry leading OEMs that are functionally equivalent to clinical equipment to maximize synergies during site transfer and scaleup activities
Scalable Unit Operations
50,000 sq. ft. production and warehouse facility to support newly expanded clinical manufacturing and future commercial scale production. Completed April 2025 Harmonized quality systems and programs to facilitate an efficient, safe, compliant, cost effective phase-in progression of projects from clinical through commercial manufacturing operations
Scalable Unit Operations
50,000 sq. ft. production and warehouse facility to support newly expanded clinical manufacturing and future commercial scale production. Completed April 2025
Scalable Unit Operations
Capability to provide complete turnkey packaging services in bottles and blisters with different levels of serialization according to client aggregation requirements
Adjacent 50,000 ft2 warehouse facilities completed in May, 2025, enable advanced materials management, packaging, labeling, and other supporting functions.
Scale Up
To successfully increase batch sizes and mitigate risks requires experience, flexibility and precise planning. Increasing a clients’ batch size efficiently requires a thorough understanding of technologies, capabilities and equipment operations at each scale. A team with mature and experienced quality and regulatory experience is essential.
At Serán, we support programs through every stage of drug development and formulation, catering to both small and large molecule drug substances. Our proven track record includes the safe production of highly potent active pharmaceutical ingredients (HPAPIs), underscoring our commitment to safety and quality.
TECH TRANSFER
The successful execution of the technology transfer process for the development and manufacturing of the final commercial dosage form is essential. This intricate process demands comprehensive planning and an experienced team to handle the analytical and quality support required. The complexities of tech 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.
Program Management
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.
Reliable Partner
While partnering with a new CDMO may introduce potential challenges, these can be effectively managed and mitigated through proper planning. Implementing proven strategies and processes, coupled with thorough planning, frequent communication, and meticulous execution, can minimize risks and ensure a smooth transition. Serán's expertise, proven strategies, and commitment to quality make us a reliable partner to navigate the complexities of scale-up and technology transfer, ensuring your project reaches its milestones efficiently and safely.
Capabilities
- Semi-continuous spray drying and secondary drying
- Twin-screw extrusion and wet granulation
- Advanced mixing/blending and dry granulation using roller compaction
- Multi-layer tableting and broad encapsulation capabilities
- Advanced batch, semi-continuous, and continuous tablet coating
- Integrated automation, process control technologies and on-site analytical lab enables operational and quality control
- Bottle/Blister/Sachet packaging, labeling and Serialization
- Supply chain for worldwide distribution
- Close proximity to international airport and port of entry
- End-to-end processing in one location
Technologies
- Spray Drying
- Hot Melt Extrusion
- Nano-milling
- Fluid-bed
- Controlled and modified release
- Tableting
- Capsule filling
- Granulation
- Encapsulation
- Powder filling
- Coatings
- Packaging & Labeling
- Supply Chain
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