Custom Protein Generation

Drug Substance Manufacturing

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

WuXi Biologics greatly simplifies ADC and other bioconjugate drug development by providing CMC development, all preclinical activities and the entire supply chain in one centralized region.

ADC Map-min

We also provide world-class expertise in conjugation approaches and can handle highly potent and toxic payloads. Extensive payload and linker libraries as well as full mAb library generation utilizing a variety of mAb discovery platforms is available for R&D studies to evaluate conjugate product options and to generate lead drug candidates.  Full analytical capabilities to fully characterize this class of therapeutics as well as establish and validate lot release and stability methods are available in-house.  We offer a full-range of development and manufacturing services both as an integrated package and standalone services. Our comprehensive solutions for ADCs / bioconjugates include:

Click below to open a .pdf file for examples of the types of carriers, linkers & payloads we have worked with or have available
payloadlinkercarrier-screenshot

The following services can be provided by WuXi AppTec

  • Discovery chemistry services for payload and linker
  • Linker and payload intermediate synthesis and cGMP manufacture
  • Supporting drug development services (also in-house) that include genomics/biomarker/companion diagnostic development, discovery biology, oncology translational science, DMPK, toxicology, clinical trials and more!

Case Study

99.5% percent of CMC and preclinical work conducted for an ADC global IND

Antibody and Payload Conjugation Development

We offer extensive expertise and have experience with a wide-variety of conjugation chemistries including:

  • Lysine/cysteine
  • Polysaccharide
  • Site-specific conjugation (THIOMAB™, non-natural amino acid, SMARTag™ enzyme-assisted, sugar based etc.)
  • Milligram to hundreds of grams of ADC
  • Non-GMP and GMP production of ADC
  • Other biologics conjugation (PEGylation, HESylation, etc.)

In addition, we offer guidance on the type of conjugation approaches that may work best for your project and conduct the necessary developability and manufacturability studies to help assess the future success of the molecule in development and beyond.

New Approaches to Conjugation

Through WuXi Biologics’ R&D efforts, we have developed a novel linker for Lysine-based conjugation that demonstrates higher reactivity, better solubility and a more flexible range of conjugation temperatures. This linker offers the ability to conjugate to other molecules beyond IgGs.  In addition, we have developed a unique payload chemistry to provide more homogenous drug loading for cysteine-based conjugation.

 

Analytical development and characterization of ADCs

We leverage in-house expertise and state-of-the-art analytical equipment to characterize drug candidates at various stages of development, including UV/VIS, HPLC, cIEF, LC-MS. Our analytical assessment of ADCs encompasses all stages of development, including drug-to-antibody ratio, free-drug content, ADC affinity, protein concentration, aggregation, PI, peptide mapping and potency tests.


Formulation Development, Fill & Finish for ADCs

Here is the typical formulation development and fill/finish process for antibody drug conjugates.

ADC Formulation/Fill & Finish Development Elements Studies
ADC Liquid formulation development pH screening Heat stress study
Agitation study
Excipient screening Heat stress study
Freeze-Thaw study
Agitation study
Lyophilization cycle development Heat stress study
Container closure selection Accelerated stability
Long-term stability
Technology Transfer Formulation/Lyophilization process development
ADC fill and finish GMP facility for Phase I/II

GMP Manufacture of ADC / Bioconjugation 

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WuXi Biologics operates a new state-of-the-art facility dedicated to GMP Drug Substance (DS) bioconjugation and Drug Product (DP) fills in Wuxi, China. This brings the GMP supply chain for critical protein / mAb intermediates, toxins/linkers and the ADC / Bioconjugate DS and DP within a short drive of each other. The site will feature an OEB5 Isolator for payload and linker weighing and dissolution and in nearly all product contact surfaces will utilize single-use systems to minimize risk throughout the manufacturing process. This facility was designed to handle OEB5 (or Safebridge III or IV) compounds used as payloads or toxins. In addition the facilities meet U.S. FDA, EMA and NMPA GMP standards. See table below for manufacturing capacities.

mAb Linker Payload ADC
Lab scale  mg ~ mg
Non-GMP pilot scale mg ~ 10s g
cGMP manufacturing  > 2kg  > 5 kg > 5 kg Up to 2kg

 

ADC / Bioconjugate Drug Product Fill and Finish

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  • Fully-automated processing throughout formulation and filling process
  • Validated vial container and closure configuations of 2, 6, 10 and 20 mL
  • Liquid filling up to 100,000 vials/batch/day (2R vial)
  • Lyophilized DP capacity up to 25,000 vials/batch/day (2R vial)

Also Available

  • Nitrogen blanketing
  • Light protected material handling from start of fill processing to final package steps
  • Liquid and lyo fills for Parenterals (e.g., small molecule and peptide therapeutics)

WuXi Biologics News for ADC / Bioconjugate

WuXi Biologics to Expand Integrated Biologics Conjugation Solution Center to Include Commercial Manufacturing
WuXi Biologics and NBE-Therapeutics Announce Comprehensive ADC Development and Manufacturing Partnership
WuXi Biologics Congratulates BioAtla on FDA Clearance of IND Application for CAB-AXL-ADC
WuXi Biologics Initiated Construction of a State-of-the-Art Integrated ADC Solution Center
WuXi Biologics Congratulates Ambrx and ZMC for Successful Dosing of a Novel Antibody-Drug Conjugate in Australia

To learn more about WuXi Biologics’ truly ONE services
or to receive a quote – Click Here

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