Catalent (Novo Holdings) vs Samsung Biologics: CDMO Comparison

Side-by-side comparison of Catalent (Novo Holdings) 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.

Harmans, MD · Gosselies, BE
Signal Score
75/100
Quality (FDA + GMP)
79/100
FDA inspections
1
— NAI / VAI / OAI
0 / 1 / 0
FDA warning letters
0
EMA GMP certificates (active)
0
MHRA GMP certificates (compliant)
0
Clinical programs (matched)
0
Capacity
Available
Modalities
Monoclonal Antibody, Recombinant Protein, ADC, AAV, mRNA, Plasmid DNA, Fill-Finish
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

  • Catalent (Novo Holdings) has FDA inspections on record (1); 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.

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

What to evaluate for mRNA/LNP programs

Both Catalent (Novo Holdings) 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: Catalent (Novo Holdings) vs Samsung Biologics

Which has the stronger FDA inspection record, Catalent (Novo Holdings) or Samsung Biologics?

Both Catalent (Novo Holdings) and Samsung Biologics maintain clean enforcement records on file — no FDA warning letters and no OAI classifications. Catalent (Novo Holdings) has 1 FDA inspection on record; Samsung Biologics has 0.

Which is better for mRNA/LNP manufacturing — Catalent (Novo Holdings) or Samsung Biologics?

Both Catalent (Novo Holdings) 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?

Catalent (Novo Holdings) carries a Signal Score of 75/100 and Samsung Biologics carries 68/100 — a small lead for Catalent (Novo Holdings). 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 Catalent (Novo Holdings) 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.

Find & compare CDMOs →
Sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.