Figure 3 — Analytical coverage for a monoclonal antibody.
Every attribute a regulator will ask about.
Purity & size analysis
Aggregate and fragment quantification, under reduced and non-reduced conditions.
Charge variant profiling
Ion exchange chromatography, with capillary isoelectric focusing where higher resolution is needed.
Glycosylation analysis
Glycan structure profiling and comparison against reference product.
Process impurity testing
Host cell protein and DNA quantification, plus process-related impurity profiling.
Functional characterisation
Target-binding and Fc receptor assays, and cell-based potency where required.
Identity & structure
Confirmation of primary structure and molecular identity.
Validated to ICH Q2(R1).
Method development from first principles, or transfer and revalidation of an existing method into your facility.
Validation covers specificity, linearity, range, accuracy, precision, detection and quantitation limits, and robustness.
Deliverables: validation protocol, complete raw data package, validation report, and a written method SOP suitable for a regulatory dossier.
Head-to-head against the reference product.
For biosimilar programmes, we design and execute comparability studies structured around ICH Q5E: defined quality attributes, statistically justified acceptance ranges, and integrated assessment across structural, physicochemical, and functional dimensions.
Figure 4 — How comparability is assessed. Illustrative data, not client results.
From clone to submission.
For manufacturers developing a biosimilar end to end, we structure the work as a phased programme with defined deliverables at each stage.
Figure 5 — Indicative biosimilar development schedule.
Regulatory documentation
Gap analysis against DGDA, WHO, and ICH. CTD Module 3 preparation. QTPP and CQA definition. Query response support when a regulator comes back with questions.
Technical training
Analytical methods, upstream and downstream processing, quality systems, and regulatory requirements. Delivered at your facility or ours, with competency assessment and certification.
Figure 6 — From first contact to final report.
Confidentiality is agreed before technical detail is exchanged. Scope, timeline, and cost are fixed before work starts. Raw data belongs to you and is delivered with the report.