Compendium

Cell-Line & Antibody Catalog — Production Lines, Therapeutic mAbs, Reagents

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Cell-Line & Antibody Catalog

This Tier 3 family index bundles two practical reagent catalogs that every biomedical lab and every biologics-manufacturing CMO needs to navigate: (1) the cell lines used in research and biologics manufacturing, and (2) the antibodies used as research reagents and as approved therapeutics. All quantities in SI (mass g, concentration mol/L = M, viable cell density vc/mL, productivity g/L for bioreactor titres).

Production cell lines (biologics manufacturing)

CHO — Chinese Hamster Ovary

The dominant biologics workhorse: an estimated ~70 % of approved recombinant biotherapeutic proteins are manufactured in CHO (and rising — almost all post-2015 launches). Originated from Theodore Puck’s 1957 isolation of a single Cricetulus griseus ovary; the line has the convenient features of being adherent or suspendable, growing to high densities, supporting plasmid amplification via selectable markers, performing reasonably human-like glycosylation, and being non-susceptible to most human viruses.

Sub-lineSelection / propertiesNotable users
CHO-K1Parental clone (ATCC CCL-61)Many academic + industrial; protein-free adapted variants
CHO-SSuspension-adapted; serum-freeThermo Fisher; transient + stable
CHO-DG44DHFR⁻/⁻ (both alleles deleted; Lawrence Chasin Columbia 1980); MTX-amplificationGenentech historic; Roche/Genentech franchise
CHO-DXB11 / CHO-DUKX-B11DHFR⁻ (one allele deleted + one missense); MTX-amplification (Urlaub & Chasin 1980)Lonza historical; many legacy lines
CHO-GS (CHOK1SV)Glutamine synthetase selection (MSX); proprietary Lonza GS Xceed; supports glutamine-free mediaLonza GS gene-expression system (most-licensed industrial system)
CHOZN GSSigma-Aldrich (Merck KGaA) ZFN GS-KO hostAvailable to small + large pharma
ExpiCHOHigh-titer transient expression up to ~3 g/L; serum + animal-freeThermo Fisher kit; method scientists’ workhorse for hundreds-of-mg scale
CHOK1SV-KO-GSGS-KO + Fut8-KO afucosylated for ADCC mAbsLonza GS Effex
CHO-ZN-CDWuXi Biologics chemically-defined host
Cellca CHO-GSSartorius (formerly Boehringer Ingelheim) BI HEX

Industrial titres: typical fed-batch mAb processes 5–10 g/L; high-performers 12 g/L (Lonza, BI, Samsung Biologics) and intensified perfusion targets 15–25 g/L (WuXi). Costs of goods for a mAb produced at 5 g/L scale are roughly US$50–100 per g of bulk substance (drug-substance only; fill-finish + regulatory adds another order).

Other mammalian production lines

  • NS0 — mouse myeloma (Royal Free Hospital London); historic GS-system origin; some legacy mAbs (e.g. Synagis palivizumab, Soliris eculizumab earlier batches)
  • SP2/0-Ag14 — mouse hybridoma fusion partner; Remicade infliximab originally
  • YB2/0 — rat myeloma; afucosylated glycosylation; Mogamulizumab Poteligeo (Kyowa Hakko Kirin POTELLIGENT)
  • HEK293 (human embryonic kidney, Graham 1973) — widely used in transient expression with PEI or Lipofectamine; HEK293T (large T antigen for SV40-ori plasmids); HEK293-F (FreeStyle suspension); Expi293 (Thermo high-titer transient); HEK293EBNA; mainstays of AAV manufacturing (most current AAV gene therapies including Zolgensma, Luxturna and CSL Hemgenix use HEK293-derived processes via triple transfection)
  • Per.C6 — Crucell→Janssen; immortalised human retinoblast; some Eylea earlier batches; Ad5 vector production
  • BHK-21 — baby hamster kidney (Stoker & MacPherson 1964); vaccines + recombinant Factor VIII (Kogenate Bayer earlier process)
  • Vero — African green monkey kidney (Yasumura & Kawakita 1962); polio vaccine (IPV Salk legacy + Sabin reformulated cell-culture), rabies (Verorab Sanofi, Imovax), Japanese encephalitis (Ixiaro), rotavirus, COVID-19 inactivated (CoronaVac/Sinovac, Covaxin Bharat Biotech)
  • MDCK — Madin-Darby canine kidney (1958); influenza vaccines (Flucelvax Seqirus = first US cell-culture flu vaccine 2012; FluBlok recombinant separate)
  • EB66 — duck embryonic stem cell-derived (Vivalis→Valneva); flu + viral vector platform
  • AGE1.CR + AGE1.HN — ProBioGen; muscovy duck and human neuronal lines
  • MRC-5 / WI-38 — human diploid fibroblast (1962 Hayflick + 1966 Jacobs); MMR, varicella (Varivax, Zostavax), rabies, hepatitis A vaccines

Insect / yeast / bacterial

  • Sf9 + Sf21 (Spodoptera frugiperda ovarian) — BEVS baculovirus expression vector system (Smith, Summers 1983); FluBlok recombinant influenza (Sanofi/Protein Sciences), Provenge sipuleucel-T, Cervarix HPV (GSK), Novavax Nuvaxovid NVX-CoV2373 COVID vaccine
  • High Five Hi5 (Trichoplusia ni) — generally higher protein expression
  • S2 (Drosophila) — non-lytic insect expression
  • Escherichia coli — BL21(DE3) (T7 lac-inducible; Studier & Moffatt 1986); BL21 Star (DE3) (RNase E mutant; mRNA stability); Rosetta + Rosetta 2 (rare-codon tRNA supplementation); Origami (trxB gor mutations for cytoplasmic disulphide bond formation); SHuffle (NEB; trxB gor + cytoplasmic DsbC); ArcticExpress (cold-active chaperonin); C41/C43 (DE3) (Walker — membrane protein expression); Lemo21 + T7 Express (NEB); Tuner (lacY⁻ tunable expression). Used for: insulin first recombinant 1982 (Humulin Genentech→Lilly), filgrastim Neupogen, somatropin Genotropin, asparaginase, various Fab fragments (certolizumab Cimzia uses E. coli Fab + PEG)
  • Yeast — Saccharomyces cerevisiae (insulin Novolin Novo, GLP-1 oligonucleotide-RP, vaccines Recombivax Engerix HBV); Komagataella phaffii (formerly Pichia pastoris; AOX1 alcohol-oxidase methanol-inducible; Wegener/Cregg/Stillman 1985); GlycoSwitch / GlycoFi humanised glycosylation engineered Pichia (GlycoFi sold to Merck 2006); Cresentino/Lonza Pichia platform. Approved: Kalbitor ecallantide, Jetrea ocriplasmin, recombinant insulin biosimilars

Quality control

  • Mycoplasma testing — PCR (multiple primers; MycoSEQ Thermo, MycoAlert Lonza luminescence), Hoechst 33258 DNA fluorescence stain, broth + agar culture (28-day GMP); ≥ 5–35 % of cell lines globally are mycoplasma-contaminated (Drexler & Uphoff 2002; Olarerin-George & Hogenesch 2015 estimated 11 % of RNA-seq datasets)
  • STR profiling — short tandem repeat authentication (ANSI/ATCC ASN-0002 standard, 9-loci minimum; expanded panels 17–24 loci); ICLAC (International Cell Line Authentication Committee) misidentification database — ~600+ lines known misidentified (HeLa contamination, KB = HeLa, Hep-2 = HeLa, INT-407 = HeLa, etc.)
  • Sterility (USP <71>); endotoxin (LAL, recombinant Factor C — rFC Lonza PyroSmart NextGen since 2020); adventitious agents (in vitro + in vivo + species-specific PCR; NGS-based AAV testing emerging)

Disease research cell lines

Cancer cell lines

The NCI-60 panel (introduced 1990 — Boyd & Paull; Shoemaker 2006 review) is the historical drug-screening panel. The far larger CCLE — Cancer Cell Line Encyclopedia (Barretina 2012, Ghandi 2019; Broad + Novartis; 947 lines original, 1,078 in 2019 update) and the DepMap project (Tsherniak 2017; ~1,800 lines screened with CRISPR + RNAi for dependencies) are the modern references. Sanger COSMIC Cell Lines Project complementary. CCLE + DepMap mutation, copy number, expression, methylation, proteomics (Nusinow 2020), metabolomics (Li 2019), drug sensitivity (PRISM Corsello 2020).

Tumour typeCommon lines
BreastMCF-7 (ER+ PR+; Soule 1973; pleural effusion); MDA-MB-231 (TNBC; mesenchymal-like); MDA-MB-468 (TNBC; basal); T47D (ER+); ZR-75-1; BT-474 (HER2+/ER+); SKBR3 (HER2+); MCF10A (non-tumorigenic immortalised; basal-like comparator); 4T1 (mouse syngeneic TNBC model)
LungA549 (NSCLC adenocarcinoma; KRAS G12S); H1299 (NSCLC; p53-null); H1975 (EGFR L858R + T790M; osimertinib model); H460 (large cell); HCC827 (EGFR del19); PC9 (EGFR del19; Japanese origin); H358 (KRAS G12C); H226 (mesothelioma marker); H82 (SCLC); H446 (SCLC); Calu-3 (apical-basal polarised)
ColorectalHCT116 (MSI-high; KRAS G13D); HT29 (MSS; BRAF V600E); SW480 + SW620 (matched primary + nodal metastasis); LoVo; DLD-1; RKO (MLH1-silenced MSI-high); Caco-2 (enterocyte differentiation; gold-standard for intestinal permeability Papp absorption assays — Caco-2 monolayers TEER trans-epithelial electrical resistance)
PancreasPANC-1; MIA PaCa-2; BxPC-3 (KRAS wt — atypical); AsPC-1 (ascites); Capan-1; PaCa-2; HPAF-II; SUIT-2 (Japan); KPC-derived (Kras-Trp53-Pdx1 mouse)
LiverHepG2 (hepatoblastoma — widely used despite hepatocellular ≠ hepatocyte); Hep3B (HCC + HBV); HuH-7 (HCC; HCV replicon host); PLC/PRF/5; HepaRG (differentiable bipotent — closest in-vitro to primary hepatocyte ADME)
Brain (glioblastoma)U-87 MG (origin uncertain — STR reassignment ETH Zurich 2016); U-251 MG; LN229; T98G; A172; LN18; SF268; D54-MG; patient-derived neurosphere cultures (Singh, Dirks 2003) increasingly preferred
MelanomaSK-MEL-28; A375 (BRAF V600E — vemurafenib study substrate); MeWo; Malme-3M; SK-MEL-2; SK-MEL-5; UACC-62; UACC-257; M14; Lu1205
ProstatePC3 (AR⁻ small-cell-like; lytic bone met origin); DU145 (AR⁻); LNCaP (AR+ T877A mutant; androgen-responsive); 22Rv1 (AR-V7 expressing; castration-resistant model); VCaP (AR-amplified ETS+); C4-2 + C4-2B (castration-resistant LNCaP-derived)
Leukaemia / lymphomaK562 (CML BCR-ABL); HL-60 (APL; differentiation); Jurkat (T-ALL; TCR signalling); U937 (histiocytic); THP-1 (AML M5; monocyte/macrophage); MV4-11 (FLT3-ITD AML); MOLM-13 (FLT3-ITD AML); KASUMI-1 (AML); Kasumi-6; Raji (Burkitt EBV+); Daudi (Burkitt); Ramos; SU-DHL-6 (DLBCL); OCI-Ly1/3/7; Karpas-422; KMS-11 (MM); MM.1S; H929 (MM); RPMI-8226 (MM); KG-1 + KG-1a (AML)
OvarySK-OV-3 (HER2+); OVCAR-3; OVCAR-5/8; IGROV-1; A2780 (cisplatin-sensitive + -R derivatives); ES-2; CaOV3; Kuramochi (HGSOC validation Domcke 2013)
CervixHeLa (Henrietta Lacks 1951 — first immortal human line; cervical adenocarcinoma; HPV18+; Skloot 2010 history); CaSki; SiHa (HPV16+); ME-180; C-33A (HPV-)
GastricAGS; MKN-45; MKN-7; KATO-III; N87 (HER2+); SNU-1, SNU-5, SNU-216, SNU-668 (Korean SNU panel); NUGC-3, NUGC-4
RenalA498; 786-O (VHL⁻; HIF1α stabilised); Caki-1; Caki-2; ACHN; UOK series (NCI Linehan)
BladderT24; J82; UM-UC-3; 5637; RT4; HT1376; SW780 (FGFR3 fusion model)

Patient-derived models — replacing 2D lines

Patient-derived xenografts (PDX; mouse-grown); organoids (PDO; 3D suspension culture in Matrigel/BME with niche cytokines — Clevers 2009 first intestinal LGR5+ stem cell organoid); organoid biobanks: HUB Organoid Technology, ATCC organoids, Cellesce manufacturing platform, OOO Onkos (oncology PDO); HCMI Human Cancer Models Initiative (NCI + Sanger + Hubrecht + CRUK); patient-derived primary cultures with conditional reprogramming (Schlegel ROCK inhibitor Y-27632); spheroids (low-attachment plates Corning Ultra-Low Cluster); air-liquid-interface ALI for airway

iPSC / ESC

  • WiCell (Madison Wisconsin) — H1 / WA01 and H9 / WA09 (Thomson 1998 first hESC); + many iPSC lines
  • Coriell Institute (Camden NJ) — major repository for biobank + iPSC; CIRM California iPSC Repository, NINDS iPSC, SCRC (UK Stem Cell Bank Hinxton)
  • ATCC — iPSC + ESC
  • Allen Cell Collection (Allen Institute Seattle) — open fluorescent reporter lines edited into WTC11 (Bruce Conklin/Coriell parent); ~50 endogenously tagged proteins (lamin B1, tubulin, actin, paxillin, tom20, fibrillarin, ZO-1, Sec61B, etc.); fully open data
  • CDI Fujifilm Cellular Dynamics International (Madison) — commercial differentiated-cell products: iCell Cardiomyocytes (used widely for cardiotoxicity drug screening Maddah 2015; Stem.Cell.Sciences); iCell Neurons; iCell Hepatocytes; iCell Endothelial Cells; iCell Astrocytes; allogeneic clinical pipeline (iPSC-derived NK CYNK-001, dopaminergic FCDI-RPE)
  • BlueRock Therapeutics (Bayer; bemdaneprocel ND0023 Parkinson’s dopamine neurons Phase II 2025); Aspen Neuroscience (Loring; ANPD001 autologous PD); Lineage Cell Therapeutics OpRegen (RPE for dry AMD); ESI BIO Russell; Axol Bioscience UK
  • Differentiation protocols: cardiomyocyte (Lian 2013 Wnt biphasic; Kattman 2011); neuron (Chambers 2009 dual-SMAD; Kim 2011 floor plate dopamine; LMX1A); hepatocyte (Si-Tayeb 2010 4-stage Activin-FGF-HGF-OSM); pancreatic β-cell (Pagliuca/Melton 2014 → Vertex VX-880 Phase II T1D zimislecel 2024 promising data); intestinal organoids (Spence 2011); cerebral organoids (Lancaster 2013 Knoblich; spheroid 2016 Pasca); kidney organoid (Takasato 2015 Little); retinal organoid (Eiraku 2011 Sasai); blood (HSC derivation remains incomplete)

Primary cells + biobanks

  • HUVEC human umbilical vein endothelial cells (Lonza Clonetics) — vascular research workhorse; passage limit ~6
  • HAEC human aortic endothelial cells; HMVEC microvascular
  • PBMC peripheral blood mononuclear cells — fresh from donors, frozen from suppliers (StemCell Technologies, Lonza, AllCells, HemaCare/Charles River, BioIVT, ZenBio); apheresis leukopaks for CAR-T research
  • Primary hepatocytes — donor liver (BioIVT, In Vitro ADMET Laboratories IVAL, Lonza, ThermoFisher, Sekisui XenoTech, Lifenet Health, Tissue Solutions); plateable + suspension; species panels (human, monkey, dog, rat, mouse, hamster)
  • CD34+ HSPC from cord blood + mobilised peripheral blood (Lonza StemPro CD34+; AllCells; StemCell Technologies; CGT-CIRM)
  • Primary T cells, NK cells, dendritic cells, monocytes — bulk + magnetically-isolated (Miltenyi MACS Microbeads; STEMCELL EasySep; Pluriselect; BD IMag)
  • Schwann cells, astrocytes, microglia, oligodendrocyte precursors — ScienCell, Lonza; HMC3 microglial line; iPSC-derived microglia (Abud 2017)

Cell-line suppliers + repositories

SupplierLocationCatalog sizeNotes
ATCCManassas VA~3,400 lines + 18,000 microbial strainsAmerican Type Culture Collection; gold-standard
ECACCSalisbury UK~3,500European Collection of Authenticated Cell Cultures (Public Health England)
DSMZBraunschweig DE~900 human + animalLeibniz-Institut DSMZ
JCRB / RIKEN BRCJapanthousandsJapanese Collection of Research Bioresources / RIKEN BioResource
CoriellCamden NJ~30,000 (mostly heritable disease + biobank lymphoblastoid)NIGMS panel + HapMap LCL; 1000 Genomes references
NCI Frederick repositoryFrederick MDNCI-60 + othersNCI DCTD Tumor Repository
Cell Lines Service CLSEppelheim DE~700German supplier
AddexBioSan Diego CA~700Customised tumours
Creative BioarrayShirley NY~10,000Many primary + difficult-to-source
Sigma-Aldrich (Merck)Resold from many—ECACC distributor + own collection
KerafastBoston MAreagents brokerLab-distributed lines + reagents
Horizon Discovery (PerkinElmer/Revvity)Cambridge UKisogenic engineered + Edit-RCRISPR-engineered isogenic cancer lines

Antibodies — research reagents

Reagent antibody scale

  • Polyclonal (mostly rabbit + goat; chicken IgY for low-cross-reactivity; older sheep/donkey) — high signal, mixed epitopes, batch-variable
  • Monoclonal — mouse hybridoma (Köhler & Milstein 1975 Nobel 1984; SP2/0, NS0, P3 fusion partners), rabbit hybridoma (Spieker-Polet 1995 → Abcam/Epitomics → Abcam RabMab; higher affinity + epitope diversity)
  • Recombinant — plasmid-encoded sequences in CHO or HEK293; reproducible across lots; Abcam RabMab Recombinant, Cell Signaling XP eXceptional Performance, Bethyl Recombinant Affinity Purified, Invitrogen Thermo Fisher recombinants
  • Phage-displayed scFv libraries (CAT/MedImmune Cambridge Antibody Technology pioneer 1990s; HuCAL Bio-Rad; MorphoSys YlanthiaPharma); yeast display (Adimab); transgenic mouse human-Ig (HuMAb Medarex now BMS, XenoMouse Abgenix now Amgen, OmniRat/OmniMouse OMT/Open Monoclonal Technology, Trianni, Ablexis, Regeneron VelocImmune)

Major reagent-antibody suppliers

SupplierStrengthsApprox catalog
Abcam (Cambridge UK; Danaher acquired 2023 US$5.7 B)Largest catalog; RabMab recombinants~110,000 antibodies
Cell Signaling Technology (Danvers MA)Signal-transduction validated (phospho-specific); XP recombinants~40,000
Thermo Fisher / InvitrogenBroad; secondary Alexa Fluor; eBioscience flow~100,000+
Bio-Rad / AbD SerotecHuCAL recombinants; secondary~50,000
Bethyl / Fortis Life SciencesAffinity-purified polyclonals~30,000
R&D Systems / Bio-TechneCytokine biology gold-standard; DuoSet ELISA~10,000
BD BiosciencesFlow cytometry conjugates~10,000 (many BV BrilliantViolet)
BioLegendFlow cytometry conjugates Spark Dye + Brilliant; PE/APC/FITC~12,000
Santa Cruz BiotechnologyLegacy mouse mAb (validation concerns)~80,000
Sigma-Aldrich (Merck)Prestige (HPA-linked)~50,000
Proteintech (Chicago + Rosemont IL + Wuhan)Polyclonal “value” tier; validating in IHC/WB~70,000
Atlas Antibodies (Stockholm)Triple A polyclonal; linked to Human Protein Atlas~25,000
OriGeneMostly TrueMAB mouse mAb~30,000
GeneTex (Irvine CA)Mid-tier; many~70,000
Novus Biologicals (Bio-Techne)Various conjugates~50,000
Boster Biological / Affinity BiosciencesAsian-market; cost-effective~10,000
MilliporeSigma Upstate / ChemiconLegacy strong WB / IPmerged into Sigma
Jackson ImmunoResearchSecondary antibodies + AffiniPure~3,000 secondaries

Antibody validation crisis + initiatives

  • Baker 2015 Nature “Reproducibility crisis: blame it on the antibodies” — up to 50 % of commercial antibodies fail specificity (Berglund 2008; Bordeaux 2010; Bordeaux et al. 2010)
  • IWGAV International Working Group for Antibody Validation (Uhlén 2016 Nature Methods five-pillar framework: genetic strategies; orthogonal; independent antibodies; tagged-protein expression; IP-MS)
  • Human Protein Atlas HPA (Uhlén Sweden 2003–; >25,000 human proteins covered; IHC across tissues + cell lines; subcellular localisation; pathology; ~20 % of antibody-database commercial reagents tracked)
  • Antibodypedia (Stockholm) — public database of antibody validation experiments
  • YCharOS Antibody Characterization through Open Science Initiative (Edwards SGC + co-author labs) — replication studies; reports for ~250 proteins as of 2025; published in F1000Research / eLife
  • Antibody Registry RRID — Research Resource Identifier mandate (Bandrowski) — most journals require RRID:AB_XXXX for antibodies as of 2023
  • eLife + PLOS “Materials Design Analysis Reporting” (MDAR) framework
  • GenScript GenCheck Ab + Twist Biosciences synthetic antibodies + Specifica antibody libraries — synthetic next-gen recombinant antibody alternatives

Therapeutic antibodies — full catalog

Approved therapeutic monoclonal antibodies + Fc-fusions + ADCs + bispecifics + radioimmunoconjugates now total ~135 distinct molecular entities globally (≈ 100+ FDA approvals + additional EMA-only + China-only NMPA approvals). Naming convention: stems indicate target/source (-zumab humanised mouse + -umab fully human + -ximab chimeric + -omab fully mouse; -ciclib kinase; sub-stems indicate target — -tuzu = tumour, -li = immunomodulator, -ki = interleukin, -ner = neural — but the WHO renamed stems in 2021 abolishing source distinctions for new mAbs).

Anti-TNF — the immunology workhorses

mAbSourceBrandSponsorFirst approvalPeak revenue
infliximabchimericRemicadeJ&J / Merck1998 RA + CDUS$10 B 1998–2014
etanerceptFc fusion (TNFR2-Fc)EnbrelAmgen / Pfizer1998 RAUS$9 B peak
adalimumabfully humanHumiraAbbVie (originally CAT + BASF + Abbott)2002 RAUS$21 B 2022 — historic #1; biosimilars 2023+ erosion
golimumabfully humanSimponi / Simponi AriaJ&J2009 RA—
certolizumab pegolPEG-Fab (E. coli)CimziaUCB2008 CD/RA—

Adalimumab biosimilars now in market in US 2023–2024: Amjevita (Amgen), Cyltezo (BI), Hyrimoz (Sandoz), Hadlima (Samsung Bioepis/Organon), Hulio (Mylan Viatris/Fujifilm Kyowa), Yusimry (Coherus), Idacio (Fresenius), Yuflyma (Celltrion), Abrilada (Pfizer), Simlandi (Alvotech/Teva).

Anti-CD20

  • rituximab Rituxan/MabThera Roche-Genentech-Biogen (chimeric; first oncology mAb FDA 1997 NHL); biosimilars Truxima Celltrion, Ruxience Pfizer, Riabni Amgen, Rituxio Mylan
  • ofatumumab Arzerra/Kesimpta Novartis (fully human; CLL + relapsing MS s.c.)
  • obinutuzumab Gazyva/Gazyvaro Roche (glycoengineered afucosylated; iNHL + CLL)
  • ocrelizumab Ocrevus Roche (humanised; primary progressive MS — first PPMS therapy 2017; ~US$7 B 2023)
  • ublituximab Briumvi TG Therapeutics (glycoengineered MS 2023)
  • veltuzumab (cancer; legacy); ibritumomab tiuxetan Zevalin RIT (¹⁰⁹Y)

Anti-IL-6 / IL-6R

  • tocilizumab Actemra/RoActemra Roche-Chugai (anti-IL-6R; RA + GCA + systemic JIA + CRS + COVID-19); ~US$3 B 2023
  • sarilumab Kevzara Sanofi-Regeneron (anti-IL-6R; RA + PMR)
  • siltuximab Sylvant EUSA Pharma (anti-IL-6; Castleman disease)
  • satralizumab Enspryng Roche (anti-IL-6R; NMOSD)
  • olokizumab Artlegia R-Pharm (anti-IL-6; RA Russia)
  • ziltivekimab Cordis/Novo (anti-IL-6; CV outcomes ZEUS Phase III)

Anti-IL-17

  • secukinumab Cosentyx Novartis (fully human; psoriasis 2015, AS, PsA, axSpA, HS; ~US$5 B 2023)
  • ixekizumab Taltz Eli Lilly (humanised; PsO + PsA + axSpA + nrAxSpA)
  • brodalumab Siliq / Lumicef / Kyntheum Bausch / Kyowa Kirin / LEO (anti-IL-17RA; PsO; black-box suicide signal in trials)
  • bimekizumab Bimzelx UCB (IL-17A + IL-17F; PsO + PsA + HS + AS 2023–2024 broad EU + US)

Anti-IL-23 (p19) / IL-12/23 (p40)

  • ustekinumab Stelara J&J (IL-12/23 shared p40; PsO + PsA + CD + UC; ~US$10 B 2023; biosimilars 2024+ Wezlana Amgen first)
  • guselkumab Tremfya J&J (anti-p19; PsO + PsA + UC + CD 2025)
  • risankizumab Skyrizi AbbVie (anti-p19; PsO + PsA + CD + UC 2024; ~US$7.8 B 2023)
  • tildrakizumab Ilumya / Ilumetri Sun Pharma / Almirall (anti-p19; PsO)
  • mirikizumab Omvoh Eli Lilly (anti-p19; UC 2023 + CD 2024)

Anti-IL-4Rα

  • dupilumab Dupixent Sanofi-Regeneron (IL-4 + IL-13 by blocking shared α-receptor; AD, asthma, EoE, prurigo nodularis, CRSwNP, COPD eosinophilic 2024, CSU chronic spontaneous urticaria 2025); fastest-growing biologic; ~US15 B 2024

Anti-IL-5 / IL-5R

  • mepolizumab Nucala GSK (anti-IL-5; severe eosinophilic asthma, EGPA, HES, CRSwNP, COPD eosinophilic 2025)
  • reslizumab Cinqair / Cinqaero Teva (i.v.)
  • benralizumab Fasenra AstraZeneca (anti-IL-5Rα; afucosylated → ADCC eosinophil killing; eos asthma, EGPA)
  • depemokimab GSK (long-acting 6-monthly; SWIFT Phase III 2024)

Anti-IL-13

  • tralokinumab Adbry / Adtralza LEO Pharma (AD)
  • lebrikizumab Ebglyss Eli Lilly / Almirall (AD; OS approval EU 2023 + US 2024)
  • cendakimab Bristol-Myers Squibb (EoE)

Anti-IL-31 / IL-13 / OX40

  • nemolizumab Mitchga / Itepekimab Galderma + Maruho (anti-IL-31Rα; prurigo nodularis 2024, AD)
  • amlitelimab Sanofi (anti-OX40L; OCEANA Phase III AD)
  • rocatinlimab Amgen (anti-OX40; ROCKET Phase III AD)

Anti-IgE

  • omalizumab Xolair Roche-Novartis-Genentech (asthma + CSU + food allergy 2024 first FDA approval for food allergy); ~US$4 B 2023
  • ligelizumab Novartis (CSU)

Anti-VEGF / VEGFR / Ang2

  • bevacizumab Avastin Roche-Genentech (anti-VEGF-A; multiple solid tumours; biosimilars Mvasi Amgen, Zirabev Pfizer, Alymsys, Vegzelma, Avzivi)
  • ramucirumab Cyramza Eli Lilly (anti-VEGFR2)
  • ranibizumab Lucentis Roche-Novartis-Genentech (Fab fragment; wet AMD); biosimilars Byooviz, Cimerli, Ahzantive
  • aflibercept Eylea Regeneron + Eylea HD 8 mg formulation 2023 (recombinant Fc fusion VEGFR1+R2 domains; PFK extended dosing); ~US$9.4 B 2023 (combined; Bayer ex-US share)
  • brolucizumab Beovu Novartis (scFv-Fc; intraocular inflammation signal)
  • faricimab Vabysmo Roche (anti-VEGF-A × Ang-2 bispecific CrossMab; up to 16-week dosing; ~US$3.7 B 2024)
  • conbercept Lumitin Chengdu Kanghong (China; like aflibercept)
  • aflibercept biosimilars 2024+ — Yesafili (Biocon Viatris), Opuviz (Samsung Bioepis), Pavblu (Amgen first US 2024)

Anti-α4β7 / α4β1

  • vedolizumab Entyvio Takeda (anti-α4β7; gut-selective; UC + CD; s.c. formulation 2023; ~US$5 B 2023)
  • natalizumab Tysabri Biogen / Elan (anti-α4 integrin; MS + CD; PML risk JC-virus screening)
  • etrolizumab Roche failed 2020

Anti-CD52, CD38, CD30, CD22, CD33, CD25

  • alemtuzumab Lemtrada Sanofi-Genzyme (CD52; relapsing MS — restricted use post-marketing 2019 RMP)
  • daratumumab Darzalex / Darzalex Faspro s.c. J&J/Genmab (CD38; MM; ~US$10 B 2023)
  • isatuximab Sarclisa Sanofi (CD38; MM)
  • mezagitamab TAK-079 Takeda (CD38; ITP Phase III); felzartamab MorphoSys (CD38; renal transplant antibody-mediated rejection)
  • brentuximab vedotin Adcetris Seagen-Pfizer (CD30 ADC)
  • inotuzumab ozogamicin Besponsa Pfizer (CD22 calicheamicin ADC; ALL)
  • gemtuzumab ozogamicin Mylotarg Pfizer (CD33 calicheamicin ADC; AML)
  • basiliximab Simulect Novartis (CD25; transplant induction)
  • camidanlumab tesirine ADCT-301 ADC Therapeutics (CD25 PBD ADC HL Phase II)

Anti-EGFR

  • cetuximab Erbitux Eli Lilly / Bristol-Myers Squibb (chimeric; mCRC RAS-wt + SCCHN)
  • panitumumab Vectibix Amgen (fully human)
  • necitumumab Portrazza Eli Lilly (NSCLC; minimal use, withdrawn EU)
  • amivantamab Rybrevant J&J (EGFR × MET bispecific; NSCLC; MARIPOSA + PALOMA s.c. faspro)
  • nimotuzumab Theracim / TheraCIM-hR3 Cuba/Biocon (China + India approval; SCCHN)
  • depatuxizumab mafodotin failed glioblastoma

Anti-HER2

  • trastuzumab Herceptin Roche-Genentech (1998; BC + GC); biosimilars Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti, Zercepac
  • pertuzumab Perjeta Roche (HER2 dimerisation; BC; CLEOPATRA + APHINITY)
  • trastuzumab emtansine Kadcyla T-DM1 + trastuzumab deruxtecan Enhertu T-DXd (ADCs)
  • margetuximab Margenza MacroGenics (Fc-engineered → ↑ ADCC; SOPHIA)
  • zanidatamab Ziihera Jazz / Zymeworks (biparatopic HER2 × HER2 — ECD2 + ECD4; HER2-amplified BTC 2024)
  • disitamab vedotin Aidixi RemeGen (China)
  • HLX02 Henlius biosimilar; many

Anti-RANKL, anti-OPG

  • denosumab Prolia + Xgeva Amgen (RANKL; osteoporosis + bone metastases; ~US$6 B 2023); biosimilars 2025+ Wyost Sandoz, Ospomyv

Anti-PCSK9

  • alirocumab Praluent Sanofi / Regeneron (later sold to Regeneron 2020)
  • evolocumab Repatha Amgen (FOURIER + FOURIER-OLE)
  • (small molecule + siRNA see Drug Targets file)

Bispecific antibodies (selected — see Drug Targets file for full BiTE list)

  • catumaxomab Solitomab (EpCAM × CD3; trifunctional — withdrawn) — historical
  • blinatumomab Blincyto (CD3 × CD19; first BiTE 2014)
  • emicizumab Hemlibra Roche-Chugai (Factor IXa × Factor X mimicking factor VIII; hemophilia A; ~US$4.8 B 2023)
  • faricimab Vabysmo (VEGF-A × Ang-2)
  • mosunetuzumab Lunsumio (CD20 × CD3 FL)
  • glofitamab Columvi (CD20 × CD3 DLBCL)
  • epcoritamab Epkinly (CD20 × CD3 DLBCL/FL)
  • teclistamab Tecvayli (BCMA × CD3 MM)
  • elranatamab Elrexfio (BCMA × CD3 MM)
  • linvoseltamab Lynozyfic (BCMA × CD3)
  • talquetamab Talvey (GPRC5D × CD3 MM)
  • tarlatamab Imdelltra (DLL3 × CD3 SCLC)
  • cadonilimab Kaitanni Akeso (PD-1 × CTLA-4; China NMPA cervical 2022)
  • ivonescimab Summit / Akeso SMT112 (PD-1 × VEGF-A; HARMONi-2 NSCLC superiority vs pembro 2024)
  • amivantamab Rybrevant (EGFR × MET)
  • zenocutuzumab Bizengri Merus (HER2 × HER3; NRG1+ 2024)

Anti-amyloid β (Alzheimer’s)

  • aducanumab Aduhelm Biogen / Eisai (2021 accelerated approval despite EMERGE/ENGAGE inconsistency; commercially withdrawn January 2024)
  • lecanemab Leqembi Eisai / Biogen (2023 full approval; CLARITY-AD ~27 % CDR-SB slowing; q2-weekly i.v. → s.c. autoinjector 2025; ARIA-E ~13 % treated)
  • donanemab Kisunla Eli Lilly (2024 full approval; TRAILBLAZER-ALZ 2; targets pyroglutamate Aβ N3pG; ARIA-E ~24 % treated)
  • gantenerumab Roche (failed GRADUATE 2022)
  • remternetug LY3372689 Lilly (TRAILRUNNER-ALZ 3; s.c.; advancing 2025)
  • ALZ-801 Alzheon (oral aggregation inhibitor APOE ε4/ε4 carriers)

Anti-CGRP / CGRP-receptor (migraine)

  • erenumab Aimovig Amgen/Novartis (anti-CGRP-R)
  • fremanezumab Ajovy Teva (anti-CGRP)
  • galcanezumab Emgality Eli Lilly (anti-CGRP)
  • eptinezumab Vyepti Lundbeck/Alder (anti-CGRP i.v. quarterly)

Anti-C5 (complement)

  • eculizumab Soliris Alexion (now AstraZeneca; PNH, aHUS, gMG, NMOSD; legendary US$500k/yr launch price 2007)
  • ravulizumab Ultomiris AstraZeneca (longer-acting q8-weekly s.c. + i.v.)
  • crovalimab Piasky Roche (s.c. monthly self-administered PNH 2024)
  • pozelimab Veopoz Regeneron (CHAPLE disease 2023)

Other complement

  • pegcetacoplan Empaveli + Syfovre (intravitreal GA dry AMD; APL-2) Apellis (C3)
  • avacincaptad pegol Izervay Iveric Bio→Astellas (anti-C5 RNA aptamer; GA 2023)
  • iptacopan Fabhalta Novartis (oral factor B; PNH 2023, C3G 2024, IgAN 2024)

Anti-RSV F

  • palivizumab Synagis AstraZeneca/Sobi (paediatric prophylaxis 1998; historic)
  • nirsevimab Beyfortus Sanofi/AstraZeneca 2023 (extended half-life Fc YTE mutations; ~US$1.7 B 2023; broad infant prophylaxis season)
  • clesrovimab Enflonsia Merck (2025 first season; HARMONIE-equivalent)

Other notable approved mAbs

  • aclaridine + abrilumab (gut)
  • belimumab Benlysta GSK (BAFF/BLyS; SLE + LN)
  • ianalumab + telitacicept (BAFF; SLE Phase III)
  • inebilizumab Uplizna Horizon Therapeutics→Amgen (CD19 NMOSD + IgG4-related disease 2024)
  • ofatumumab + ocrelizumab + ublituximab MS (above)
  • omburtamab (B7-H3; not approved)
  • olaratumab Lartruvo Eli Lilly (PDGFRα; soft-tissue sarcoma; withdrawn 2019 failed Phase III post-accelerated)
  • bezlotoxumab Zinplava Merck (C. difficile toxin B; CDI recurrence)
  • raxibacumab Abthrax GSK (Bacillus anthracis PA; biodefence)
  • obiltoxaximab Anthim Elusys (anthrax)
  • ibalizumab Trogarzo TaiMed/Theratechnologies (CD4; multidrug-resistant HIV)
  • lenacapavir not a mAb (capsid inhibitor)
  • adintrevimab + bebtelovimab + tixagevimab+cilgavimab Evusheld + bamlanivimab — SARS-CoV-2 spike (mostly EUA-only, withdrawn as variants drifted)
  • vunakizumab + sintilimab + tislelizumab + camrelizumab — anti-PD-1 China
  • spesolimab Spevigo Boehringer Ingelheim (IL-36R; GPP generalised pustular psoriasis 2022)

Antibody engineering & formats

Formats

  • Fab (~50 kDa) — pegylated certolizumab Cimzia; ranibizumab Lucentis
  • F(ab’)₂ — pepsin-digested; some antivenoms
  • scFv (~25 kDa) — bispecifics BiTE blinatumomab + brolucizumab Beovu; CAR ectodomains
  • Diabody / DART / TandAb (~50–110 kDa) — flotetuzumab MacroGenics
  • Full-length IgG ~150 kDa
  • Nanobody / VHH (sdAb) ~12–15 kDa — caplacizumab Cablivi Sanofi-Ablynx (vWF nanobody; aTTP); Ozoralizumab Taisho (anti-TNF Japan); Sonelokimab MoonLake Phase III
  • Fc fusion — etanercept Enbrel (TNFR2-Fc); abatacept Orencia (CTLA-4-Fc); aflibercept Eylea (VEGFR1/2-Fc); alefacept (withdrawn); rilonacept Arcalyst (IL-1 trap)
  • scFv-Fc / minibody — brolucizumab; gantenerumab

Subclasses

IgG subFunctionsExamples
IgG1Best ADCC + CDC; long half-life ~21 d via FcRnMost cancer mAbs (rituximab, trastuzumab, daratumumab)
IgG2Weak Fc effectorPanitumumab (avoid CDC ototoxicity); denosumab
IgG3Strong but shorter ½rare
IgG4Effector-silent + Fab-arm exchangePembrolizumab Keytruda (S228P stabilised), nivolumab, dupilumab, mepolizumab

Most modern Fc-effector-null designs use N297A, N297Q (aglycosyl), LALA (L234A/L235A) or LALA-PG triple to eliminate FcγR binding for checkpoints + bispecifics.

Engineering specs

  • Bispecific platforms: knob-in-hole (KIH; Genentech Carter 1996); CrossMAb (Roche; CH1-CL swap on one arm); DuoBody (Genmab controlled Fab-arm exchange); BiTE (Amgen; tandem scFv); DART + TRIDENT (MacroGenics); TandAb (Affimed); Triomab (Trion); BiCMAb; XmAb (Xencor); BiClonics (Merus); CrossMab + JNJ-Janssen + 2:1 format (Roche)
  • Glycoengineering: afucosylation enhances FcγRIIIa binding and ADCC ~10–100×: POTELLIGENT (BioWa Kyowa Hakko Kirin; mogamulizumab, obinutuzumab, benralizumab, inebilizumab, ublituximab, magrolimab); GlymaxX (ProBioGen)
  • Half-life extension: YTE mutations M252Y/S254T/T256E (MedImmune; nirsevimab Beyfortus); LS mutations M428L/N434S (~3-fold extension; many discovery mAbs); pegylation (cimzia certolizumab); HSA-fusion (albiglutide withdrawn)
  • Pegylation: certolizumab (40 kDa branched PEG); pegfilgrastim Neulasta; peginterferon; pegademase
  • PROTAC-ADC — investigational
  • ImmTAC — Immunocore TCR-anti-CD3 bispecific (tebentafusp Kimmtrak Immunocore 2022 uveal melanoma; gp100-HLA-A*02:01 × CD3)

ADC payloads

Payload classExamples
MMAE / MMAF (auristatin tubulin)Adcetris brentuximab, Polivy polatuzumab, Padcev enfortumab, Tivdak tisotumab, Aidixi disitamab
DM1 / DM4 (maytansine tubulin)Kadcyla T-DM1, Elahere mirvetuximab DM4
Calicheamicin (DNA dsDNA cleavage)Mylotarg, Besponsa
Dxd / DX-8951 (exatecan derivative; topo-I)Enhertu T-DXd, Trodelvy SN-38 also topo-I, Datroway dato-DXd, Hernexeos HER3-DXd, ifinatamab DXd, raludotatug DXd, patritumab DXd, ifinatamab
SN-38 (irinotecan active topo-I)Trodelvy
PBD-dimer (pyrrolobenzodiazepine; SG3199)Zynlonta loncastuximab tesirine; camidanlumab; rovalpituzumab tesirine failed
Tubulysin / dolastatin / cryptophycin / amatoxin / GSK glucocorticoidvarious clinical

Linkers — cleavable: peptide (Val-Cit-PABC; Adcetris standard); disulphide (DM4 SPDB); hydrazone (calicheamicin); β-glucuronide; non-cleavable thioether (T-DM1). Drug-to-antibody ratio (DAR): typically 3.5–4 for older ADCs (T-DM1; brentuximab), 7.7–8 for newer T-DXd / Trodelvy / Datroway; site-specific conjugation (cysteine engineering, transglutaminase, sortase) for homogeneous DAR.

Process / manufacturing economics

  • Upstream: stable CHO clone development ~6–9 months from sequence to research cell bank; MCB master cell bank (5,000–10,000 vials at 1–10 × 10⁷ cells/vial in DMSO 10 % v/v); WCB working cell bank
  • Bioreactor scale: 200 L / 2,000 L / 5,000 L / 12,000 L / 15,000 L / 20,000 L stainless steel (Lonza Visp, Samsung Biologics Songdo, Roche Penzberg); 2,000 L SUB single-use bioreactor for clinical
  • Fed-batch typical 14-day, perfusion 60-day continuous (cell retention via TFF Repligen XCell ATF or hollow-fiber)
  • DSP downstream: Protein A capture (MabSelect SuRe Cytiva, Amsphere A3 JSR, Toyopearl AF-rProtein A Tosoh) → low pH viral inactivation → polishing AEX/CEX (MMC + monolith for larger virus) → nano-filtration → UF/DF → fill-finish
  • Cost: drug substance ~US300–500/g; list prices for mAbs typically US$10,000–100,000/g
  • Manufacturers: in-house (Roche/Genentech, J&J, BMS, Amgen, Merck, AbbVie); CDMOs/CMOs: Lonza Visp + Vacaville + Singapore (largest), Samsung Biologics Songdo (largest single-site 600,000 L capacity), WuXi Biologics + WuXi Vaccines, Boehringer Ingelheim BioXcellence, Catalent Biologics, Fujifilm Diosynth (DiaTrace; College Station + RTP + Hillerød + Teesside), AGC Biologics, JSR / KBI Biopharma, AbbVie Contract Manufacturing, Patheon (Thermo), Pfizer CentreOne, Eurofins / BioReliance

Media + sera + ancillary reagents

Cell-culture media

  • Basal media — DMEM (Dulbecco’s modified Eagle medium; high-glucose 4.5 g/L vs low-glucose 1.0 g/L); MEM (Eagle’s minimum essential); RPMI-1640 (Roswell Park Memorial — favoured for suspension hematopoietic + lymphoid); IMDM (Iscove’s; high amino acids for hematopoietic); F-12 (Ham’s; CHO original); DMEM/F-12 (50:50 — gold-standard for many primary + iPSC); McCoy’s 5A; Williams’ E (hepatocyte); MCDB series; Leibovitz L-15 (CO2-independent buffering)
  • Serum-free / chemically-defined — Gibco CTS OpTmizer (CHO-S); Lonza ProCHO 5; Sigma EX-CELL Advanced CHO Fed-Batch; Cytiva HyClone ActiPro; FUJIFILM Irvine BalanCD; Sartorius Xell HEK ViP; Gibco Expi293 Expression Medium; ScienCell DMEM-Sf serum-free
  • Stem cell media — mTeSR Plus + mTeSR1 (STEMCELL Technologies; Ludwig Thomson Madison 2006); Essential 8 / Essential 6 (Gibco; Chen 2011); StemFit AK02N (Ajinomoto); NutriStem (Sartorius/Biological Industries); StemFlex (Gibco); BG02 (BD); Naïve/PXGL/4i for naïve hPSC (Smith Cambridge)
  • Sera — fetal bovine serum (FBS) Australian or US-origin (Sigma, Gibco, ATCC, R&D, Hyclone, PAN-Biotech, Biowest, Biosera; price ~US$300–1,200/500 mL depending on grade + traceability + heat-inactivation); shortage cycles (2020–2023 prion-screening); horse serum, human AB serum, human platelet lysate (hPL — increasingly preferred for clinical-grade MSC: PL BioScience nLiven PR, Sexton Stemulate, Mill Creek PL, COOK Regentec PLTMax)
  • Growth factors — recombinant from PeproTech (now Thermo Fisher 2021 acquisition), R&D Systems, Sino Biological, ACROBiosystems, Miltenyi Premium-grade, GMP-grade Genscript / Cellular Origins / Reprocell

Cell-line maintenance equipment

Incubators (CO2 typical 5 %, hypoxia chambers for 1–5 % O2 stem-cell + cancer hypoxic; Eppendorf Galaxy, Thermo Heracell, Memmert ICOmed, Panasonic/PHCbi MCO, Binder, NuAire); biosafety cabinets class II A2 (Thermo 1300 Series, Baker SterilGARD, NuAire LabGard, Esco Airstream); microscopes (inverted phase-contrast Olympus CKX53/IX, Nikon Ts2/Eclipse, Zeiss Primovert/Axio Observer); centrifuges (Eppendorf 5810R, Thermo Sorvall Legend); pipettors (Gilson PIPETMAN, Eppendorf Research plus, Rainin, Sartorius); automated counters (Countess 3 Thermo, Vi-CELL BLU Beckman, Cellaca PLX Nexcelom, NucleoCounter ChemoMetec); LN2 cryostorage (Worthington, Custom BioGenic, MVE TruCool).

Therapeutic antibody manufacturing — specifics

Bioreactor formats + scaling

  • Stainless-steel — historically 10,000–20,000 L (Genentech Vacaville 90,000 L total CHO capacity 2009 — Avastin/Herceptin/Rituxan; Lonza Singapore Tuas 60,000 L; Roche Penzberg + Vacaville + South SF + Basel + Mannheim; Merck Carlow IE; Pfizer Grange Castle IE; BMS Devens MA + Cruiserath IE; Boehringer Biberach + Wien + Fremont; Samsung Biologics Songdo three plants Plant 1 30,000 L + Plant 2 152,000 L + Plant 3 180,000 L + Plant 4 240,000 L + Plant 5 planned)
  • Single-use bioreactor (SUB) — Sartorius BIOSTAT STR (50/200/500/1000/2000 L); Cytiva Xcellerex XDR (50/200/500/1000/2000 L); Thermo HyPerforma DynaDrive SUB up to 5000 L (introduced 2019 — largest commercially-available single-use); Pall Allegro STR; ABEC Custom Single Run (CSR) 6000 L; Eppendorf CelliGen BLU; Distek BIOne
  • Perfusion-intensified — XCell ATF (Repligen; alternating tangential flow filter for cell retention); WuXi WuXiBody continuous perfusion to 25 g/L; National Resilience continuous bioprocessing
  • Wave-mixed rocker — Cytiva ReadyToProcess WAVE 25 + 200 L (Singh 1999 invented); GE-acquired; small-scale seed

Downstream purification flow

  1. Harvest — depth filtration (Millipore Millistak+ POD, Sartorius Sartoclear), centrifugation, microfilter (0.2 μm sterile)
  2. Capture — Protein A affinity (MabSelect SuRe pcc / MabSelect PrismA / Tosoh AF-rProtein A HC / Repligen Praesto / Cytiva Fibro fibre format ~10x faster; elution pH ~3.5; titres 30–80 g resin)
  3. Viral inactivation — low-pH hold (pH 3.4–3.6 × 30–60 min) or solvent-detergent
  4. Polish 1 — anion-exchange flow-through (AEX; Q Sepharose, Capto Q, POROS HQ); removes HCP host-cell proteins, DNA, leached Protein A
  5. Polish 2 — cation-exchange bind-elute (CEX; SP Sepharose, Capto S, POROS HS) or hydrophobic interaction (HIC; Capto Phenyl) or mixed-mode (Capto MMC, Capto Adhere)
  6. Nano-filtration — Planova 20N (Asahi Kasei; 20 nm parvo retention), Viresolve Pro (Millipore), Pegasus SV4 (Pall)
  7. UF/DF — ultrafiltration/diafiltration; concentration to ~50–200 g/L; formulation buffer exchange (typically histidine pH 5.5–6.5 or phosphate)
  8. Bulk fill — single-use bag (Stedim Flexsafe, ThermoBioProcess); freeze-thaw or stored 2–8 °C
  9. Fill-finish — vial (10R glass; aluminium crimp seal Schott + Stevanato + SGD Pharma + Ompi) or pre-filled syringe (BD Hypak + Vetter + Nemera + Owen Mumford autoinjector pen)

Typical mAb formulation: 50–150 g/L; histidine 20 mM pH 6.0; sucrose or trehalose 70–250 mM; polysorbate 20 or 80 0.02–0.05 % w/v; sometimes arginine HCl for stability + viscosity reduction; protein-engineered hyaluronidase (Halozyme rHuPH20 / Enhanze) enables s.c. delivery of high-dose biologics (Herceptin Hylecta, Phesgo pertuzumab+trastuzumab+hyaluronidase, Tecentriq SC, Opdivo Qvantig 2024)

Analytical release panel

CQA (critical quality attributes) tested at release:

  • Identity — peptide map LC-MS (typically Lys-C or trypsin digestion + Orbitrap or Q-TOF mass spec)
  • Concentration — A280 (ε ≈ 1.4 mL·mg⁻¹·cm⁻¹ for typical IgG)
  • Purity — SEC-HPLC (size; HMW aggregate, monomer, LMW); CE-SDS reducing + non-reducing (replaced SDS-PAGE); cIEF (charge variants — acidic + basic species)
  • Glycan — released N-glycan (PNGase F → 2-AB labeling → HILIC-HPLC or LC-MS); critical for ADCC (G0F/G1F/G2F/sialylated) + half-life
  • Disulphide + free thiol
  • Host-cell impurities — HCP ELISA (Cygnus CHO-HCP 3G antibody; ProteinSimple), residual DNA (qPCR), Protein A leaching (ELISA)
  • Endotoxin — LAL or rFC; acceptance ≤ 0.5 EU/mg
  • Bioassay — cell-based potency assay (ADCC, CDC, neutralization, ligand-binding ELISA)
  • Sterility, mycoplasma, virus

Reference standards + biosimilar comparability

ICH Q5E + Q6B + ICH Q8/Q9/Q10 quality-by-design principles. Biosimilar approvals require analytical similarity (totality of evidence Tier 1/2/3 attributes), PK/PD bioequivalence, and a comparative clinical efficacy trial in the most-sensitive indication. Interchangeability designation (US BPCIA 351(k)) requires additional switching studies (recent 2024 FDA easing). Major biosimilar manufacturers: Sandoz (Novartis), Samsung Bioepis, Celltrion, Pfizer, Amgen, Biocon-Mylan (Viatris), Boehringer, Coherus, Fresenius Kabi, Henlius Fosun, Innovent, Alvotech, mAbxience, Polpharma Biologics.

Cell therapy starting material + autologous manufacturing

Apheresis + leukapheresis

CAR-T workflow: leukopak collection at apheresis center (Stryker Spectra Optia, Fenwal/Fresenius Amicus, Terumo BCT); typically 5–15 × 10⁹ MNC; transport at 2–8 °C (insulated shipper Pelican BioThermal Credo Cube, va-Q-tec) to manufacturing site. Wash + select (CliniMACS Plus or Prodigy automation; Miltenyi Biotec). Activate (anti-CD3 + anti-CD28 bead Dynabeads CD3/28; Miltenyi MACS GMP T Cell TransAct CD3/CD28 nanobeads; CSL Behring/StemExpress). Transduce (γ-retrovirus Kymriah + Yescarta historic; lentivirus most current; VSV-G pseudotyped; CMC challenge — viral vector capacity bottleneck industry-wide). Expand (G-Rex Wilson Wolf + Xuri Cytiva + Prodigy + CliniMACS Plus). Cryopreserve in 1–5 % v/v DMSO + albumin or CryoStor CS10 (BioLife Solutions; HemaCare CryoStor CS5 + CS10) in CryoBag (OriGen, Sartorius EZ-LIFT).

Cryopreservation logistics

GMP cryopreservation chain: controlled-rate freezer (CRF; Asymptote VIA Freeze + Cytiva, Planer Kryo 560, Custom BioGenic Systems V-1500); vapor-phase LN2 storage (Custom BioGenic, ASYMPTOTE, Worthington XLC-1830, Chart MVE Vario); dry-shipper (Cryoport Express Shipper, BioLife Solutions evo); GPS + temperature monitoring (Cryoport SmartPak, Sensitech TempTale, Berlinger Q-tag); chain-of-identity barcoding (Vineti, TraknProtect, TrakCel orchestration); cold-chain ~80–90 % of CAR-T COGS reduction opportunity area.

Selection + reagent panels

Miltenyi Biotec CliniMACS reagents (CD3+, CD4+, CD8+, CD25+, CD34+, CD138 plasma cell, CD56 NK); STEMCELL EasySep + Sepax (Cytiva GE for closed-system separation); Lonza Cocoon platform; Cellares Cell Shuttle automation (2023 first commercial deliveries); Ori Biotech IRO platform; Atvio Biotech (Tomorrow Bio); Adva Biotechnology Adva-X; Sartorius Quantum.

Adjacent

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