Fill & finish – Finalizing the product for clinical use

The complex journey of bringing a biologic to market – part 5

With GMP production of SOL-116 completed, the focus shifts to Fill & Finish—the step where drug substance becomes a ready-to-use clinical product. Although often seen as the final stage in manufacturing, Fill & Finish is a critical GMP-controlled process that ensures sterility, stability, and compliance as the product reaches patients in clinical trials. 

This phase includes aseptic filling into vials, sealing, visual inspection, labeling, and preparation for storage and distribution. For Lipum and NorthX Biologics, it marks the continuation of a close collaboration, ensuring precision and consistency all the way to the clinical setting. 

A controlled and critical process 

Fill & Finish must meet the highest standards of control and documentation. Sterility is safeguarded through validated aseptic processes and monitored cleanroom environments. Container closure integrity testing ensures that each vial is properly sealed and protected. Each filled unit undergoes visual inspection, and only products meeting strict criteria proceed to labeling and release. 

Labeling plays a vital role, not only for identification but also for regulatory and clinical compliance. All labels must be clear, accurate, and adapted to trial-specific requirements, including language, dosing, and storage conditions. This is especially important when preparing material for multiple sites and international trials. 

NorthX Biologics: Delivering clinical-ready product 

As Lipum’s new manufacturing partner, NorthX Biologics has established validated processes for Fill & Finish that align with prior Phase I specifications while supporting the needs of Phase II. The team ensures that filling parameters, packaging materials, and labeling strategies are fully compliant and adapted to the trial design. 

Close coordination between Lipum and NorthX Biologics enables smooth integration of clinical labeling, IMP batch documentation, and release planning – minimizing delays and ensuring readiness for patient use. 

Lipum’s perspective: A product ready for patients 

For Lipum, Fill & Finish is more than packaging – it’s the final step in delivering a high-quality investigational product to clinical sites. It represents both the tangible result of years of development and the beginning of real-world patient impact. 

Ensuring each vial of SOL-116 is safely filled, correctly labeled, and ready for use reflects Lipum’s ongoing commitment to quality, compliance, and patient-focused innovation. 

About this series
This series in six parts explores key aspects and aims to provide valuable insights into the complexities of the biologic drug manufacturing journey – from early process development to commercial production – through the perspectives of both the developer and the CDMO, offering a transparent discussion on the realities of bringing a biologic to market.

Read part 1 here: The importance of collaboration
Read part 2 here: Bridging innovation and execution: The critical role of technology transfer
Read part 3 here: Linking the gap from development to robust manufacturing
Read part 4 here: Moving into GMP – Turning process into product