Manufacture

In addition to producing small-scale batches to support early research, discovery, and preclinical activities, Rodon has extensive expertise in Chemistry, Manufacturing, and Control (CMC) project planning. Our team ensures that each project meets the stringent regulatory requirements for the clinical and commercial production of biologics, helping our clients navigate the complexities of biopharmaceutical development.

Rodon provides end-to-end CMC project management, supporting clients in process design, scale-up, and regulatory compliance. Our expertise includes:

• Early-stage process development to optimize product stability, scalability, and manufacturability.
• Regulatory-compliant CMC documentation to facilitate seamless regulatory submissions (IND, BLA, MAA).
• Risk mitigation strategies to prevent delays in clinical and commercial development.

Rodon offers comprehensive cell line and process development services, supporting clients in generating robust, high-yielding cell lines and optimizing bioprocesses for biologics manufacturing. Our expertise covers cell line selection, genetic engineering, and process optimization, ensuring high productivity, stability, and scalability.

We employ advanced screening, selection, and stability assessment techniques to develop cell lines that meet commercial manufacturing standards. Additionally, we specialize in process development, refining upstream and downstream workflows to enhance yield, product quality, and reproducibility.

Beyond projects initiated with us, Rodon seamlessly supports process transfer from one site to another, ensuring continuity and efficiency in manufacturing operations. Our team also provides CMC troubleshooting, addressing bottlenecks, optimizing production parameters, and ensuring regulatory compliance to enhance overall process robustness.

Rodon has deep experience in technology transfer, ensuring a smooth transition of manufacturing processes to client facilities or third-party Contract Manufacturing Organizations (CMOs). Our team supports clients throughout CMO selection, process transfer, validation, and scale-up, ensuring that manufacturing operations meet Good Manufacturing Practice (GMP) standards.

We assist in:

• Identifying and selecting the most suitable CMO based on project needs.
• Process transfer and validation, ensuring manufacturing consistency.
• Overseeing GMP-compliant production to support clinical trials and commercialization.

To ensure product integrity, we leverage Contract Analytical Laboratories (CALs) with GMP/GLP-compliant capabilities. Our approach includes:

• Comprehensive analytical method development and validation.
• Product stability and characterization studies.
• CMC dossier preparation for regulatory submission.

All process-related data is meticulously documented to facilitate knowledge transfer and regulatory compliance, helping to de-risk manufacturing scale-up and commercial readiness.

Seamless Collaboration for Project Success

Rodon’s dedicated and experienced team ensures continuous planning, coordination, and communication between all stakeholders throughout the project lifecycle. We work closely with clients, CMOs, and regulatory bodies to streamline development and manufacturing, reducing timelines and ensuring success from early development through to commercial production.

By fostering strong technical and commercial relationships, we help our partners achieve efficient, scalable, and regulatory-compliant biologics manufacturing.