Aldevron vs FUJIFILM Diosynth Biotechnologies: CDMO Comparison

Side-by-side comparison of Aldevron and FUJIFILM Diosynth Biotechnologies 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.

Fargo, ND
Signal Score
85/100
Quality (FDA + GMP)
100/100
FDA inspections
1
— NAI / VAI / OAI
1 / 0 / 0
FDA warning letters
0
EMA GMP certificates (active)
0
MHRA GMP certificates (compliant)
0
Clinical programs (matched)
0
Capacity
Modalities
Plasmid, mRNA
Research Triangle, NC · Holly Springs, NC · Hillerod, DK
Signal Score
84/100
Quality (FDA + GMP)
100/100
FDA inspections
0
FDA warning letters
0
EMA GMP certificates (active)
12
MHRA GMP certificates (compliant)
6
Clinical programs (matched)
0
Capacity
Expanding
Modalities
AAV, mRNA/LNP, Biologics

Key differences

  • Aldevron has FDA inspections on record (1); FUJIFILM Diosynth Biotechnologies 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.
  • FUJIFILM Diosynth Biotechnologies holds 12 active EMA GMP certificates; Aldevron does not appear in EudraGMDP.
  • FUJIFILM Diosynth Biotechnologies maintains 6 MHRA / UK GMP certificates; Aldevron does not.

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

What to evaluate for mRNA/LNP programs

Both Aldevron and FUJIFILM Diosynth Biotechnologies 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: Aldevron vs FUJIFILM Diosynth Biotechnologies

Which has the stronger FDA inspection record, Aldevron or FUJIFILM Diosynth Biotechnologies?

Both Aldevron and FUJIFILM Diosynth Biotechnologies maintain clean enforcement records on file — no FDA warning letters and no OAI classifications. Aldevron has 1 FDA inspection on record; FUJIFILM Diosynth Biotechnologies has 0.

How do Aldevron and FUJIFILM Diosynth Biotechnologies compare on European GMP coverage?

Aldevron holds 0 active EMA GMP certificates and 0 MHRA / UK certificates. FUJIFILM Diosynth Biotechnologies holds 12 active EMA GMP certificates and 6 MHRA / UK certificates. Use these counts as a proxy for the breadth of each CDMO's European regulatory footprint.

Which is better for mRNA/LNP manufacturing — Aldevron or FUJIFILM Diosynth Biotechnologies?

Both Aldevron and FUJIFILM Diosynth Biotechnologies 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?

Aldevron carries a Signal Score of 85/100 and FUJIFILM Diosynth Biotechnologies carries 84/100 — essentially tied for Aldevron. 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 Aldevron and FUJIFILM Diosynth Biotechnologies 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.