Commercial-Scale Biologics / mAb CDMOs
20
CDMOs tracked
20
Fully scored
12
With FDA records
29
FDA inspections
119
EMA/MHRA GMP certs
2
Warning letters
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: 13 NAI (no action), 16 VAI (voluntary action), 0 OAI (official action). Leading inspection & GMP sites: UNITED KINGDOM (25), United States (22), Germany (16), Denmark (15), Ireland (13).
Last updated 2026-06-29. 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 | 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 |
| 11 |
BR
BioReliance (Merck)
Glasgow, UK · Rockville, MD
|
81.0 | 98.8 | 2 insp · 8 GMP | — | 0 programs |
| 12 |
AV
Avid Bioservices
Tustin, CA
|
80.8 | 100.0 | 1 insp · 0 GMP | — | 0 programs |
| 13 |
NW
Northway Biotech
Vilnius, LT; Waltham (MA), USA
|
80.8 | 100.0 | 0 insp · 8 GMP | Available | 0 programs |
| 14 |
SG
Syngene International
Bangalore, India
|
79.7 | 95.9 | 2 insp · 0 GMP | — | 0 programs |
| 15 |
CRA
Curia (RNA/Advanced)
Albany, NY · Albuquerque, NM
|
79.4 | 99.9 | 2 insp · 16 GMP | — | 0 programs |
| 16 |
PG
ProBioGen
Berlin, DE
|
78.9 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 17 |
PBI
ProBio
Taipei, TW
|
78.1 | 100.0 | 0 insp · 9 GMP | — | 0 programs |
| 18 |
SI
Simtra BioPharma Solutions
Bloomington, IN · Halle, DE
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 19 |
AF
Afton Scientific
Charlottesville, VA
|
76.8 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 20 |
KD
Kindeva Drug Delivery
Woodbury, MN
|
75.9 | 98.0 | 2 insp · 3 GMP | — | 0 programs |
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 12 Biologics / mAb CDMOs with FDA inspection records and 119 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.
Related modalities
Other Modalities