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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.
Project 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.
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