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ADC Manufacturing Services

ADC Manufacturing Services

BOC Sciences possesses GMP and ISO-certified contract manufacturing facilities, and we provide custom cGMP-grade antibody-drug conjugates (ADC) manufacturing services to meet clinical and commercial development needs. We offer end-to-end ADC manufacturing services covering laboratory-scale studies, process development, pilot-scale production, and GMP manufacturing. Supported by an advanced conjugation technology platform, a robust quality management system, and an experienced technical team, our strong expertise in process development, characterization, optimization, and scale-up production ensures successful GMP manufacturing. We have established productive long-term collaborations with pharmaceutical companies, institutions, and universities.

ADC Contract Manufacturing

ADCs are formed by conjugating monoclonal antibodies (mAb) and small-molecule drugs through linkers. The specificity of mAb to tumor cells allows small-molecule drugs to target tumor tissues, effectively reducing the high toxicity of traditional small-molecule drugs and improving overall treatment efficiency. Most ADCs follow similar action mechanisms, including antibody-mediated receptor binding, ADC internalization, the release of payload cytotoxicity, and bystander effects. The success of ADC depends on several key factors: target antigens, antibody types, payload types, linker types, conjugation methods, and target indications.

Fig 1. GMP capability for payloads and linkers (BOC Sciences Authorized).

BOC Sciences offers comprehensive services for ADC manufacturing, including antibody production, linker chemistry, payload conjugation, and formulation development. We have a team of experienced scientists and engineers who are well versed in various technologies and have expertise in ADC development. We also provide custom solutions and can customize specific ADC manufacturing processes to meet specific customer requirements. We have a strong focus on collaboration and work closely with our clients to understand their needs and provide a personalized services.

Our Core ADC Manufacturing Services

The advent of ADCs provides a promising treatment for many types of cancer. As increasing numbers of ADC drugs enter clinical trials, the industry is shifting gradually from traditional technologies to novel and powerful techniques to afford ADCs. These techniques include exploring new tumor antigens, new antibody structures, new payloads, new linkers, and advanced conjugation methods that improve the therapeutic window of ADC. BOC Sciences offers a complete and flexible range of ADC manufacturing services, from process development & analytical support to GMP production. Our services include biopharmaceutical contract research and development, process development, cGMP manufacturing, QA and QC solutions for scientific research, preclinical, clinical, and commercial supply.

ADC cGMP Manufacturing

We have ADC manufacturing facilities and systems compliant with international cGMP standards, supporting production and delivery from preclinical samples to commercial batches. The manufacturing process covers the entire workflow including antibody reduction, linker and cytotoxin conjugation, purification, concentration, and sterile fill-finish, ensuring each step meets quality and regulatory requirements.

Service Highlights:

  • Compliant with ICH and FDA/EMA regulatory standards
  • Supports batch production from gram to hundred-gram scale
  • Provides complete batch records, Certificates of Analysis (COA), and registration support documents
  • Experienced QA/QC team monitors and releases products throughout the process

ADC Purification

Efficient purification is a critical step to ensure the quality and safety of ADC products. We employ multiple purification technologies including hydrophobic interaction chromatography (HIC), ion exchange chromatography (IEC), size exclusion chromatography (SEC), and tangential flow filtration (TFF) to remove unconjugated toxins, free antibodies, and other impurities.

Service Highlights:

  • Effectively removes residual small molecules and conjugation by-products
  • Flexible process scales (laboratory, pilot, commercial)
  • Customizable chromatography media and gradient programs
  • Offers purification process development, scale-up, and quality control support

ADC Formulation Development

We provide professional ADC formulation development services to help clients optimize product stability, reduce aggregation issues, and improve shelf life. Formulation strategies are tailored based on the physicochemical properties of the ADC, intended administration routes, and clinical requirements, selecting the most suitable buffer systems and excipient combinations.

Service Highlights:

  • Covers development of both liquid and lyophilized formulations
  • Evaluates the impact of pH, salt concentration, osmolality, and excipients on ADC stability
  • Supports accelerated stability testing, long-term stability studies, and lyophilization process optimization
  • Provides formulation screening, DOE experiment design, and data analysis

ADC Fill/Finish

We offer GMP-compliant sterile fill-finish services for ADCs, including both liquid and lyophilized powder forms, ensuring product stability, safety, and traceability throughout formulation and filling. The entire process is conducted in Grade A/B cleanrooms equipped with high-precision filling equipment and comprehensive aseptic control systems.

Service Highlights:

  • Supports multiple filling formats (glass vials, syringes, etc.)
  • Uses 0.22 μm sterilizing filters to ensure product sterility
  • Provides both liquid filling and lyophilized powder filling
  • Offers filling validation, seal integrity testing, and sterility test reports

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Our Competitive Edge

Delivery of over 200 ADC molecules per year
mg to g for early-stage development
Efficient delivery cycle

Semi-synthesis, total synthesis and cGMP fermentation
Full capability from DNA to ADC cGMP production
Multiple site-specific conjugation techniques

Facilities and Capabilities of ADC Manufacturing

AD Systems and EquipmentQC Lab Systems and Equipment
HPLC 2DHPLCInstrument GroupHCP
Bio-LCSEC-HPLCResidual Host Cell DNA
cIEF (iCE3)cIEFResidual Protein A
CE (PA800)Peptide Mapping (UPLC)Protein Concentration by UV
Q-TOF ( Agilent 6530B)IEX-HPLC (Ion-Exchange)EM/Microbiology Group
UPLC ( Agilent 1290 Infinity)CE-SDS (reduced and non-reduced)Bioburden
CE (Agilent)Biochem/Chem GroupEndotoxin
Flow CytometryCell-based BioassaySterility
GCELISA / Western BlotWater Testing
qPCR instrumentsTrypsin Inhibitory ActivityEnvironmental Monitoring
2DHPLCSDS-PAGE (reduced and non-reduced)Particulate Matter

Our ADC Manufacturing Process

Scheme Design and Contract Customization

Project Evaluation and Technology Transfer

At the project initiation stage, we closely communicate with clients to understand the ADC components (antibody, linker, cytotoxin) and project goals, assess process feasibility, and complete the necessary technology transfer tasks.

  • Project requirements analysis and technical background review
  • Quality document review for antibody, linker, and toxin
  • Evaluation of existing process package and recommendations for supplementary development
  • Formulation and execution of technology transfer plan

Payload/Linker Synthesis

Process Development and Scale-Up

For the ADC structures provided by clients, we conduct process development and parameter optimization to ensure a stable and controllable scale-up from small scale to pilot scale, compatible with subsequent GMP manufacturing.

  • Screening and optimization of conjugation reaction conditions (buffer, pH, temperature, reaction time, etc.)
  • Design of drug-antibody ratio (DAR) control strategies
  • Preparation of small-scale (mg to g level) ADC samples
  • Pilot scale process validation (10 L to 100 L scale)

Scheme Design and Contract Customization

ADC Purification and Concentration

Using multiple chromatography techniques and filtration methods, we efficiently purify the ADC reaction mixtures to remove free toxin, unconjugated antibody, and other impurities, ensuring the purity and safety of the final product.

  • Hydrophobic interaction chromatography (HIC) to remove free toxin
  • Ion exchange chromatography (IEC) to optimize charge distribution
  • Size exclusion chromatography (SEC) to remove aggregates
  • Tangential flow filtration (TFF) for concentration and buffer exchange

Analysis, Purification and Characterization

Formulation Development and Optimization

To enhance the storage stability and formulation performance of ADC products, we develop and screen suitable formulation systems and determine final formulation parameters.

  • Buffer system design and stability evaluation
  • Optimization of pH, ionic strength, and excipient ratios
  • Lyophilization process development and finished product stability studies
  • Compatibility testing of formulations with different packaging materials

cGMP Manufacturing and Filling

ADC Sterile Fill/Finish

Following purification and formulation development, the ADC undergoes final fill-finish under GMP-compliant sterile conditions to ensure compliance with clinical use requirements.

  • Pre-filtration sterilization (0.22 μm)
  • Filling operations in Grade A/B cleanrooms
  • Selection of filling formats: liquid formulation or lyophilized powder
  • Filling volume, seal integrity, sterility testing, and batch documentation

Result Delivery

Quality Control and Release Testing

Quality control is integrated throughout the entire ADC manufacturing process. We have an independent QC laboratory conducting comprehensive quality testing and release review of raw materials, intermediates, and final products.

  • Physicochemical testing: DAR value, purity, molecular integrity (HPLC, LC-MS, SEC, etc.)
  • Biological testing: binding activity, cytotoxicity analysis (ELISA, cell-based assays)
  • Microbiological testing: sterility, endotoxin, visible particles
  • Stability studies: accelerated and long-term testing under ICH conditions

Frequently Asked Questions

Frequently Asked Questions

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More About ADC Manufacturing

* Only for research. Not suitable for any diagnostic or therapeutic use.
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