From Lead to IMPD, Early CMC Success for a Belgian Biotech
The Challenge of Turning a Monoclonal Antibody Lead Into a Clinical Candidate
A Belgian biotech company had an ambitious monoclonal antibody programme ready to move from promising science to its first clinical trial. With only 18 months and a €6m budget, the company needed to transform early research into a regulatory-ready programme supporting First-in-Human (FIH) studies.
This required a dedicated CMC partner who could:
Select the right antibody lead with manufacturability in mind.
Oversee cell line development in the U.S. and ensure Master Cell Bank creation.
Identify and contract the right European CDMO for end-to-end GMP manufacturing.
Guide process development, scale-up, and GMP runs with risk control.
Coordinate clinical supply chain readiness to avoid delays.
Compile a complete IMPD Quality Module ready for regulatory submission.
Without this expertise, the biotech risked fragmented execution, costly delays, and a dossier that regulators could reject.
3Biotech’s End-to-End Early Development Strategy
The company partnered with 3Biotech to manage the entire CMC journey across two continents. We:
Selected the lead candidate using a decision matrix that balanced efficacy with manufacturability factors such as acidic stability, low immunogenicity, high affinity...
Oversaw cell line development in the U.S., screening over 2,000 clones to select the one with the highest titer (>5/gl) and with the expected manufacturability and efficacy.
Led CDMO selection in France, designing the RFP, auditing facilities, and securing the partner best aligned with project needs.
Guided process development and scale-up, optimising upstream and downstream processes, validating analytical methods, and addressing risks before GMP runs.
Coordinated clinical supply chain readiness, aligning stability studies, clinical in-use stability, packaging, and release documentation to secure on-time supply.
Authored the IMPD Quality Module, integrating data from multiple partners into a coherent, audit-ready dossier.
Impact: From Candidate Selection to First-in-Human in 18 Months
Antibody lead selected with manufacturability confirmed.
U.S. cell line developed with titer > 5g/l and French CDMO onboarded.
Process scaled to 2,000l, GMP batches released, and clinical supply secured.
IMPD submitted with a complete Quality data package.
Programme delivered on time, on budget (€6m), and ready for FIH trials.
Why 3Biotech?
We connected continents, vendors, scientists, and regulators into one project team. By anticipating issues, synchronising timelines, and maintaining focus, we ensured this biotech’s early CMC journey was efficient, cost-effective, and clinical-ready.