ADC manufacturing

ADC manufacturing is a multistep process that can be divided into three distinct stages: cGMP production of the antibody, cGMP synthesis of the drug-linker complex, and conjugation to form an ADC. The conjugated antibodies undergo extensive purification and finished as ADC products upon the completion of fill-finishing. As a complex entity containing three components (monoclonal antibody, linker, and payload), the function of ADCs is highly sensitive to each component’s attributes. Due to clinical research on ADC drugs progresses and commercial demand surges, many companies turn to CDMOs (Contract Development, Manufacturing Organizations) for "end-to-end" services like develop, manufacture, and test ADCs. As an ADC contract manufacturer partner, ChemExpress provides comprehensive services across the entire ADC supply chain, from antibody, payload linker to conjugation and final drug product fill-finish.

ADC One Stop end-to-end CDMO service of ChemExpress

ChemExpress offers one stop end-to-end CDMO service solutions for Antibodies and ADCs, providing antibodies, payload linkers, conjugates and drug products to biotech & pharma from R&D to commercialization, ensuring high quality and efficiency across the development and production of antibody, payloads, linkers, and extensive experience in linker compound synthesis. Our facilities include R&D laboratories, kilogram-scale GMP plants and commercial-scale GMP manufacturing plants. This enables us to provide end-to-end project support from discovery to commercialization.

Let’s talk about how to smooth the path for your next ADC project.

References
  • [1] Atlas Genet Cytogenet Oncol Haematol. 2018;22(3):112-122

Simplifying your ADC manufacturing journey with ChemExpress

ChemExpress is respected as a key contract service provider in the ADC area with more than 10 years of experience. We provide unique services for the development, fast-track, and commercial cGMP manufacture of ADCs including the payload linker, Antibody and bioconjugation. which supports the client's program through clinical trials and into the commercial stage.

ADC Process Development

  • Payload and Linker Manufacturing Capabilities
  • ADC Conjugation Capabilities
  • Antibody Manufacturing Capabilities
  • Analytical Development and Testing Center
  • 80+ Payloads, 400+ Linkers and 1000+ Linker Syntheses
  • Thorough strategies for chiral control and the preparation of chiral impurities
  • GMP high potency (HP) lab and plant to produce chemical payloads in scales from gram to kilo scale
  • Validated cleaning procedures and OEL limit down to 10 ng/m3
  • Reactor sizes from 1 L to 100 L with a temperature range of -80°C to +150°C
  • Global Regulatory support services
  • All common reactions including HP hydrogenation reaction and HP cryogenic reaction
  • Isolation and drying equipment, lyophilization and chromatography equipment
  • Evaluate and customize ADC products with various conjugation types and methods
  • Troulbe shooting and optimize conjugation process development
  • Conjugation scale of bioconjugation discovery from milligram to gram scale
  • ADC PC Sample production
  • ADC Process validation
  • IND Sample production
  • Freeze-drying process scale-up
  • Clinical trial sample preparation
  • Antibody PC Sample production
  • Antibody Process validation
  • DP Process validation
  • Commercial antibody drug substance production
  • Commercial ADC drug substance production
  • Commercial formulation (Sterile Powder for Injection and Aqueous Injection) production
  • Toxicological batch drug substance production of antibody and conjugate
Payload and Linker
  • Analytical method development and validation of Related substances,Chiral impurities,Residual solvents, Assay, Elemental impurities,Product releasing,GMP lab validation support and etc
  • Experienced analytical method development and validation on Genotoxic impurities
  • Analytical method development and validation for deuterated ratio and content of deuterated drugs using high-resolution mass spectrometry (HDX-MS)
  • Structural elucidation capabilities equipped with LC-MS/MS, QE, IR, UV, NMR, XRPD, TGA, DSC and etc
  • 2D-LCMS for advanced mass spectrometry analysis
  • Analytical method transfer,Process scaling up supporting, In-process control,Intermediate releasing,GMP product releasing, GMP enviromental monitoring,Microbial and Endotoxin testing & GMP sample releasing
  • Cleaning method deverlopment,validation,and process control
  • A Wide Range of Temperature Stability Conditions, including -65℃ ± 5℃, -20℃ ± 5℃, and 5℃ ± 3℃
Conjuagation
  • Drug to Antibody Ratio—HIC/RP/UV/LC-MS
  • Concentration—UV/BCA/Bradford
  • Aggregation—HPLC
  • Free-drug—HPLC/LC-MS
  • Binding activity—ELISA
  • Fragements—R-CE/ NR-CE
  • Charge variant—CEX /iCIEF
  • Unconjugated antibody—HIC/ Native-MS
  • Endotoxin
Antiboday
  • Drug substance analytical method development
  • Confirmation of Drug substance analytical method
  • Confirmation of formulation analytical method
  • Cytological activity method transfer and confirmation

Center of excellence for ADC manufacturing

The Ma'anshan site in China specializes in ADC Payload-Linker, HPAPI, API, Intermediates Process Development and Manufacturing.

  • Designed to process OEB5 (OEL 0.01μg/m3) compounds
  • Highly potent kilo GMP Manufacturing Plant：~47,000ft²
  • HPAPI plant total reactor capacity: 4,000L, ranging from 5L-100L reactors
  • Compliant with FDA/EMA/NMPA regulatory standard
  • 5 GMP HPAPI production lines (OEB5, OEL 0.01μg/m3 )
  • Designed with maximum operation efficiency, which include negative pressure isolators to meet operation requirements of the most toxic highly potent APIs
  • Multiple prep-HPLC and Lyophilizers (0.5 m²-5 m²)
  • Compliant with FDA/EMA/NMPA regulatory standard, passed 1 EU QP audits

The Chongqing site offers comprehensive end-to-end Antibody-Drug Conjugate (ADC) Contract Development and Manufacturing Organization (CDMO) services. We specialize in antibodies, ADC conjugations, and ADC drug products, providing full support from R&D through to commercialization. This seamless integration of ADC drug development ensures complete coverage while minimizing management and switching costs.

  • Area of structure：~600,000ft²
  • 1 Antibody Line: 200L、500L、2000L, reserve a number of 2000L production line
  • 1 Conjugation/ADC DS Line: 50L、100L、200L、300L、500L
  • 2 DP filling  Lines  (with Lyophilizer) : 10m²、25m²
  • Production capacity: 50 batches, about 1.9 million doses of ADC per year

Related services

Download Our ADC Handbook

  • ChemExpress ADC Products handbook (ADC)

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