Lonza vs Samsung Biologics: CDMO Comparison

Side-by-side comparison of Lonza and Samsung Biologics on independent FDA inspections, EMA and MHRA GMP certificates, clinical-program activity, and CDMO Signal Score. Data sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.

Lonza → 78.2
Basel, Switzerland
Signal Score
78/100
Quality (FDA + GMP)
95/100
FDA inspections
2
— NAI / VAI / OAI
0 / 2 / 0
FDA warning letters
0
EMA GMP certificates (active)
3
MHRA GMP certificates (compliant)
5
Clinical programs (matched)
1
Capacity
Modalities
AAV, Lentiviral, Cell Therapy, mRNA, ADC, Monoclonal Antibody, Recombinant Protein
Incheon, South Korea
Signal Score
68/100
Quality (FDA + GMP)
FDA inspections
0
FDA warning letters
0
EMA GMP certificates (active)
0
MHRA GMP certificates (compliant)
0
Clinical programs (matched)
0
Capacity
Modalities
Monoclonal Antibody, Recombinant Protein, ADC, mRNA

Key differences

  • Lonza has FDA inspections on record (2); Samsung Biologics does not yet appear in the FDA inspection database.
  • Both maintain clean enforcement records — no FDA OAI classifications or warning letters on file for either CDMO.
  • Lonza holds 3 active EMA GMP certificates; Samsung Biologics does not appear in EudraGMDP.
  • Lonza maintains 5 MHRA / UK GMP certificates; Samsung Biologics does not.

On a 13-modality CDMO landscape, both Lonza and Samsung Biologics qualify as mRNA/LNP manufacturers; Lonza carries the higher composite Signal Score for mRNA/LNP programs in this comparison.

What to evaluate for mRNA/LNP programs

Both Lonza and Samsung Biologics qualify as mRNA/LNP CDMOs. When choosing between them for mRNA/LNP programs, weigh these four dimensions specifically — each carries through to the side-by-side scorecard above.

IVT mRNA synthesis

Assess in-vitro transcription scale, capping strategy (co-transcriptional vs enzymatic), and template sourcing. These drive yield, purity, and cost.

LNP formulation

LNP encapsulation via microfluidics determines potency and tolerability. Confirm lipid sourcing, formulation freedom-to-operate, and particle-size control.

Plasmid / starting material

mRNA needs a DNA template. Check whether the CDMO supplies GMP plasmid in-house or coordinates a plasmid CDMO — it affects timelines.

Cold chain & stability

mRNA-LNP products are temperature-sensitive. Evaluate frozen storage, fill-finish, and the stability program.

See all mRNA/LNP CDMOs ranked by Signal Score →

Frequently asked: Lonza vs Samsung Biologics

Which has the stronger FDA inspection record, Lonza or Samsung Biologics?

Both Lonza and Samsung Biologics maintain clean enforcement records on file — no FDA warning letters and no OAI classifications. Lonza has 2 FDA inspections on record; Samsung Biologics has 0.

How do Lonza and Samsung Biologics compare on European GMP coverage?

Lonza holds 3 active EMA GMP certificates and 5 MHRA / UK certificates. Samsung Biologics holds 0 active EMA GMP certificates and 0 MHRA / UK certificates. Use these counts as a proxy for the breadth of each CDMO's European regulatory footprint.

Which is more active in clinical-stage manufacturing — Lonza or Samsung Biologics?

Lonza is matched to 1 ClinicalTrials.gov record as a manufacturing partner; Samsung Biologics is matched to 0. Higher counts indicate broader sponsor exposure but say nothing about approved-product track record — pair this number with each CDMO's profile page for context.

Which is better for mRNA/LNP manufacturing — Lonza or Samsung Biologics?

Both Lonza and Samsung Biologics are tagged as mRNA/LNP CDMOs in our directory, so both are credible options for mRNA/LNP programs. The most important differentiator for mRNA/LNP selection is typically ivt mrna synthesis: Assess in-vitro transcription scale, capping strategy (co-transcriptional vs enzymatic), and template sourcing. These drive yield, purity, and cost. Review each CDMO's profile and inspection record before shortlisting.

What does the Signal Score gap mean in practice?

Lonza carries a Signal Score of 78/100 and Samsung Biologics carries 68/100 — a small lead for Lonza. The Signal Score combines quality (FDA inspections + EMA/MHRA GMP), operational performance, financial stability, and capacity intelligence. CDMOs cannot pay to influence their score.

Evaluating Lonza and Samsung Biologics for a program?

Use the free AI matchmaker to weigh both against your specific requirements — capacity, modality, regulatory record, geography — and surface other qualified options.

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Sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.