Best Biologics / mAb CDMOs by Signal Score

← All Biologics CDMOs Best Clean FDA History Commercial Scale

CDMOs tracked

Fully scored

With FDA records

FDA inspections

EMA/MHRA GMP certs

Biologics CDMOs manufacture monoclonal antibodies, fusion proteins, and other large molecules in mammalian (typically CHO) cell culture. It is the largest and most mature segment of contract manufacturing, spanning early clinical supply through multi-thousand-litre commercial production.

Selecting a biologics CDMO turns on bioreactor scale and modality fit (mAb, bispecific, fusion protein), titer and cell-line strategy, fill-finish, and — above all — a clean regulatory record at commercial scale. The rankings below score each CDMO on FDA inspection history, EMA/MHRA GMP certification, clinical-program activity, and capacity.

FDA inspection outcomes across these CDMOs: 10 NAI (no action), 10 VAI (voluntary action), 0 OAI (official action). Leading inspection & GMP sites: United States (15), UNITED KINGDOM (15), Germany (14), Ireland (13), Denmark (12).

Last updated 2026-06-23. Sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.

#	CDMO	Signal Score	Quality	FDA · GMP	Capacity	Programs
1	PC Pfizer CentreOne Kalamazoo, MI · McPherson, KS	91.5	100.0	4 insp · 17 GMP	—	363 programs
2	AJ Ajinomoto Bio-Pharma Services San Diego, CA · Osaka, JP	85.6	100.0	0 insp · 1 GMP	—	0 programs
3	LB Lotte Biologics Incheon, KR · Syracuse, NY	83.7	100.0	1 insp · 0 GMP	—	0 programs
4	PR Piramal Pharma Solutions Lexington, KY · Riverview, MI · Ahmedabad, IN	83.6	95.7	5 insp · 13 GMP	—	0 programs
5	FD FUJIFILM Diosynth Biotechnologies Research Triangle, NC · Holly Springs, NC · Hillerod, DK	83.5	100.0	0 insp · 18 GMP	Expanding	0 programs
6	RB Richter BioLogics Hamburg, Germany	82.9	100.0	0 insp · 9 GMP	—	0 programs
7	CD Corden Pharma Plankstadt, DE · Caponago, IT · Boulder, CO	82.5	99.7	2 insp · 9 GMP	—	0 programs
8	MK Merck KGaA / MilliporeSigma (CDMO) Darmstadt, DE · St. Louis, MO	81.8	98.6	2 insp · 2 GMP	—	22 programs
9	EF Eurofins CDMO Planegg, DE · San Diego, CA	81.6	100.0	4 insp · 0 GMP	—	0 programs
10	EK Evonik Health Care Birmingham, AL · Vancouver, BC	81.5	99.8	2 insp · 2 GMP	—	0 programs

How we score CDMOs →

What to evaluate in a Biologics / mAb CDMO

Scale & bioreactor fit

Match validated bioreactor scale (from a few hundred litres clinical to 2,000L+ commercial) and single-use vs stainless to your dose and indication. Confirm titer expectations for your construct.

Cell line & process development

Ask whether the CDMO offers its own expression platform/cell line or works from yours, and how process development and tech transfer are handled.

Regulatory track record

Biologics programs heading to BLA/MAA need a strong commercial-scale inspection history. Cross-check FDA 483s, warning letters, and EMA/MHRA GMP coverage — all shown above.

Drug substance to drug product

Confirm whether the CDMO covers fill-finish and formulation in-house or coordinates a separate site, which affects timelines and comparability.

Biologics / mAb CDMOs — Frequently Asked Questions

Who are the top Biologics / mAb CDMOs?

By CDMO Signal's independent Signal Score, the top-ranked Biologics / mAb CDMOs include Pfizer CentreOne, Ajinomoto Bio-Pharma Services, Lotte Biologics. See the full ranked table above — scored on FDA, clinical, financial, and capacity data.

How many Biologics / mAb CDMOs have FDA inspection records?

CDMO Signal tracks 7 Biologics / mAb CDMOs with FDA inspection records and 71 EMA/MHRA GMP certificates across the group.

What should I look for in a biologics CDMO?

Match bioreactor scale and modality (mAb, bispecific, fusion protein) to your program, confirm cell-line and process-development support, and prioritize a clean FDA and EMA/MHRA record at the scale you'll commercialize at.

What is the difference between a biologics CDMO and a cell or gene therapy CDMO?

Biologics CDMOs make large molecules (antibodies, proteins) in bioreactors at litre-to-thousands-of-litre scale. Cell and gene therapy CDMOs make living cells or viral vectors in much smaller, often per-patient batches under different containment and analytics.

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