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Antibody-Drug Conjugate (ADC) Manufacturing

Illustration depicting antibody-drug conjugate (ADC) used to deliver highly active pharmaceutical ingredients

Antibody-drug conjugation (ADC) technology uses monoclonal antibodies (mAbs) to deliver potent, highly active pharmaceutical ingredients (HPAPIs) to targeted cells. In conjugated form, HPAPIs exhibit selective cytotoxicity which can spare non-target cells from toxic effects.

Realizing the vast potential of ADC technology, however, is challenging and complex. Advanced manufacturing suites and dedicated equipment are necessary to characterize the molecule and demonstrate its purity, homogeneity, and stability. Efficiently linking a unique, tumor targeted mAb to a potent, cell-killing cytotoxic small molecule drug is only the beginning—meeting ADC manufacturing needs requires a comprehensive portfolio of products and wide-ranging expertise in small and large molecule development, manufacturing, and testing.


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Keys to a Strong ADC Partnership

A seamless supply chain from gene sequence to stability testing of final drug product can reduce time to market by minimizing development and manufacturing complexity.

  • Expertise in mAb development and manufacturing, high-potency payload molecules, linkers, and conjugation
  • Experience in process development for a wide range of biologics, as well as conjugation of varied constructs
  • Project teams with comprehensive experience and a track record of successful projects
  • Extensive analytical testing capabilities and dedicated equipment
  • Extended containment strategies to protect operators and the environment from any contamination

Workflow

From cell line to mAb production services

From Cell Line to mAb Production Services

Starting with an initial cell line, a scalable process template is developed to produce cGMP batches of the monoclonal antibody (mAb). 

    Finding the missing link for your payload supply

    A highly active payload and drug-linker are matched with the mAb for eventual conjugation into an antibody drug.

    Monodisperse and activated PEGs, or Chetosensar™ technology may solve solubility challenges during drug discovery and development. Advanced payload intermediates for the most common classes of payloads can help to reduce development timelines.

      Connecting the dots with conjugation services

      The developed components of cell line, antibody, payload, and linker come together during conjugation and/or bioconjugation.

        ADC bulk drug substance (BDS) testing services

        BDS as well as final drug product receive extensive analytical testing, including stability and release testing.

          Conjugation with cytotoxic molecule

          Linkage between the antibody and a highly active payload is a critical component of an ADC, requiring a broad range of products and chemicals.

            Chromatography (Optional)

            An optional chromatographic step can be used to remove high molecular weight species such as antibody aggregates and free drug residuals, while supporting optimization of drug-antibody-ratio (DAR) and control of polydispersity.

            The Eshmuno® CMX resin has been designed for highly selective mixed mode chromatography.

              Ultrafiltration/Diafiltration

              Removing residual solvent and free drug after conjugation is necessary prior to preparation of the final formulation with the desired concentration and buffer.

              The Pellicon® Capsule is the first of its kind–a true single-use TFF device that comes ready to process ADCs in minutes.

                Sterile Filtration

                Sterilizing-grade filtration is under increasingly intense scrutiny by regulatory bodies, requiring a high degree of sterility assurance.

                  ADC BDS Final Fill and Formulation

                  The BDS is prepared for a final and unique formulation. The lyophilized dosage form is preferred and usually contains a buffer, stabilizer (e.g, trehalose or sucrose), and surfactant.