AGC Biologics vs Samsung Biologics: CDMO Comparison

How does AGC Biologics compare to Samsung Biologics for Recombinant Proteins manufacturing?

Side-by-side comparison of AGC Biologics 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.

Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
Signal Score
79/100
Quality (FDA + GMP)
100/100
FDA inspections
2
— NAI / VAI / OAI
1 / 1 / 0
FDA warning letters
0
EMA GMP certificates (active)
23
MHRA GMP certificates (compliant)
0
Clinical programs (matched)
2
Capacity
Available
Modalities
CAR-T, Cell Therapy, AAV, Lentiviral, ADC, Monoclonal Antibody, Recombinant Protein
Incheon, South Korea, Rockville, Maryland, USA
Signal Score
62/100
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
Available
Modalities
Monoclonal Antibody, Recombinant Protein, ADC, mRNA, Bispecific Antibody, Antibody Conjugate

Key differences

  • AGC Biologics 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.
  • AGC Biologics holds 23 active EMA GMP certificates; Samsung Biologics does not appear in EudraGMDP.
  • Composite Signal Score: AGC Biologics 79/100 vs Samsung Biologics 62/100 — a 17-point gap reflecting the combined quality, capacity and financial signal.

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

What to evaluate for Recombinant Proteins programs

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

Expression host & scale

Microbial hosts (E. coli, P. pastoris) suit non-glycosylated proteins; mammalian (CHO) is the workhorse for glycoproteins. Confirm validated bioreactor scale and the CDMO's experience with your target.

Purification & analytics

Downstream complexity (multiple chromatography steps, refolding for E. coli) drives cost and timeline. Ask about the orthogonal analytics package — purity, identity, potency.

Regulatory readiness

Clean FDA 483 history and EMA/MHRA GMP coverage matter — both are shown above and on each profile.

Capacity & commercial readiness

For programs heading to BLA, evaluate validated commercial scale and any approved-product track record.

See all Recombinant Proteins CDMOs ranked by Signal Score →

Frequently asked: AGC Biologics vs Samsung Biologics

How does AGC Biologics compare to Samsung Biologics for Recombinant Proteins manufacturing?

On CDMO Signal's composite Signal Score, AGC Biologics is 79/100 and Samsung Biologics is 62/100; AGC Biologics has 2 FDA inspections on record vs 0 for Samsung Biologics; European coverage is 23 active EMA+MHRA certificates for AGC Biologics vs 0 for Samsung Biologics. Both are tracked in the CDMO Signal directory as Recombinant Proteins CDMOs. The scorecard above breaks down every metric side by side — use it alongside each CDMO's individual profile for the full regulatory and clinical footprint.

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

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

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

AGC Biologics holds 23 active EMA GMP certificates and 0 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 — AGC Biologics or Samsung Biologics?

AGC Biologics is matched to 2 ClinicalTrials.gov records 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 Recombinant Proteins manufacturing — AGC Biologics or Samsung Biologics?

Both AGC Biologics and Samsung Biologics are tagged as Recombinant Proteins CDMOs in our directory, so both are credible options for Recombinant Proteins programs. The most important differentiator for Recombinant Proteins selection is typically expression host & scale: Microbial hosts (E. coli, P. pastoris) suit non-glycosylated proteins; mammalian (CHO) is the workhorse for glycoproteins. Confirm validated bioreactor scale and the CDMO's experience with your target. Review each CDMO's profile and inspection record before shortlisting.

Evaluating AGC Biologics 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.