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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Related Product Resources

Brochure: Biopharmaceutical and ADC Processing Portfolio
The document outlines the complexities of Antibody Drug Conjugate (ADC) development and emphasizes the expertise and integrated services offered to advance ADCs to market efficiently.
White Paper: Know your ADC’s Critical Quality Attributes
The increased focus on cancer has led to the rapid development of antibody drug conjugates (ADCs), a highly effective class of oncology therapeutics with a projected global market value of $7.5 billion by 2025.
White Paper: Commercializing Antibody-drug Conjugates: a CMO’s Journey
In this white paper, we outline how our organization used over 12 years of experience to establish commercial-scale ADC manufacturing capabilities.
Poster: Efficacy Screening of Antibody-Drug-Conjugates by Surface Plasmon Resonance
The intro details the complexity and challenges in characterizing antibody-drug conjugates (ADCs) and the factors influencing their effectiveness, especially in tumor targeting. It also mentions a study that expands the investigation into linker and toxin variation and binding activities using Surface Plasmon Resonance (SPR).
Poster: Novel Format Conjugates – Process and Analytical
Bioconjugation technology have greatly improved the efficacy of treatments for diseases previously difficult to address with traditional ADC therapies, leading to a demand for clinical supplies.
PDF: ADC Express™ Services for Best Candidate Selection
As a leading CTDMO in the ADC space, we offer a rapid approach for developing ADC constructs and provide efficient bioconjugation capabilities for developers needing ADC library generation. Our ADC Express™ Service facilitates the transition to development and GMP manufacturing for candidates entering the clinic.
White Paper: Benefits of Monodisperse and Activated PEGs in ADC Development
The whitepaper highlights the use of PEGs to enhance solubility in ADC development, emphasizing the importance of ADCs in delivering drugs directly to tumors while minimizing damage to healthy tissue.
White Paper: Use of Payload Core Compounds to Accelerate ADC Clinical Development Timelines
ADCs treat diseases like cancer by targeting specific cells to minimize off-target toxicity. Eleven are approved, with hundreds in development.
Technical Flyer: ADCore Payload Intermediates: Simplify Your Payload Synthesis
ADCore products are cGMP quality advanced intermediates that help accelerate drug development efforts by reducing the number of development and manufacturing steps needed to produce Maytansinoid, Dolastatin, or Pyrrolobenzodiazepine (PBD)payloads.
Technical Flyer: ChetoSensar™
Our ChetoSensar™ Technology can help to improve the solubility of ADCs and provides access to highly hydrophobic novel payloads that might not be considered.
Technical Flyer: Maytansinoid GMP Quality Payloads for Your Drug Conjugate Programs
Our maytansinoid products aim to expedite your journey to the clinic. Offerings include GMP quality DM1-Mertansine for drug conjugate programs and MAYCore™ intermediate for simplified payload synthesis. These products feature high purity, free samples, and regulatory filing support, suitable for phase I clinical studies with valid processes.
Brochure: Biopharmaceutical and ADC Process Application Guide
Developing an Antibody Drug Conjugate (ADC) demands expertise in small and large molecule development, manufacturing, formulation, and testing.
Data Sheet: Eshmuno^® CMX mix-mode chromatography resin
Case Study: Complete Single-use ADC technology, from development to scale-up
The global antibody-drug conjugate (ADC) market is rapidly expanding, with an estimated 22% compound annual growth rate (CAGR) from 2017 to 2022.
Application Note: Compatibility of a Mobius^® Single-use Solution for ADC Processing
ADCs, a fast-growing biomolecule class in oncology therapeutics, include a monoclonal antibody (mAb), linker, and cytotoxic payload, all contributing to therapeutic efficacy
Poster: Mobius^® Single-use ADC Technology Supporting ADC Processing
Our Mobius^® line provides a comprehensive single-use bioprocessing portfolio, featuring mixers, chromatography, and tangential flow filtration systems ideal for antibody drug conjugate production.
Application Note: Pellicon^® Capsules for Ultrafiltration/Diafiltration of ADCs
Tangential flow filtration (TFF) is crucial in antibody drug conjugate (ADC) manufacturing. Ultrafiltration (UF) concentrates the protein product, while diafiltration (DF) exchanges buffer and removes impurities.
White Paper: ChetoSensar™- Overcoming the Solubility Challenges of Antibody-drug Conjugates
The St. Louis (USA) manufacturing site offers over 35 years of experience in bioconjugation, APIs, excipients, and adjuvants manufacturing. With extensive analytical capabilities, dedicated compliance resources, and innovative manufacturing capabilities, the site assists customers worldwide in accelerating their drug development programs.
Brochure: Process Development and Drug Manufacturing
We provide comprehensive services for drug development and manufacturing, including technical and regulatory expertise and process development support.

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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

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.

Related Services

ADC Product Characterization

As your characterization partner we can provide expert guidance on the biological components of your antibody drug conjugate (ADC) – conducting safer, more reliable, and faster testing that helps to expedite product quality decisions at critical junctures.

mAb Product Characterization

When moving your monoclonal antibody (mAb) from concept to clinic, our product characterization services and assay packages help ensure your biotherapy’s safety, purity, and potency while expediting quality decisions at every stage.

mAb Development and Manufacturing Services

With Millipore® CTDMO Services we provide deep expertise and flexible solutions across all stages of development and manufacturing for monoclonal antibodies, bi-specific antibodies, fusion proteins, or antibody fragments. From mammalian cell line and process development to media and feed screening, master cell banking, scale-up, and GMP clinical and commercial drug substance.

ADC & Bioconjugation Contract Testing, Development, & Manufacturing Services

Millipore® CTDMO Services offers leading expertise in the conjugation of drug linkers to monoclonal antibodies (mAbs) with facilities specialized for handling highly potent compounds. Our Centers of Excellence offer ADC and Bioconjugation capabilities from pre-clinical development to commercial manufacturing of antibody-drug conjugates (ADCs).

Highly Potent APIs

Our HPAPI contract manufacturing services can support all stages of your project. Partner with an industry leader offering a global footprint and decades of experience for your drug development and manufacturing, leveraging our dedicated team and broad product portfolio with single-point project management.

Activated PEG Contract Manufacturing Services

Our PEGs contract manufacturing services can support all stages of your project. Partner with an industry leader offering a global footprint and decades of experience for your drug development and manufacturing, leveraging our dedicated team and broad product portfolio with single-point project management.

Product Services

Our dependable product services include various systems, equipment, and device qualification, validation, installation, calibration, and verification, as well as maintenance and service plans. We also offer lab services for pharma and microbiology testing, Milli-Q® lab water solutions, and the Emprove® Program.