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ADC Manufacture
BOC Sciences possesses GMP and ISO-certified contract manufacturing facilities, and we provide custom GMP-grade antibody-drug conjugates (ADC) manufacturing services to meet clinical and commercial development needs. Our strong expertise in process development, characterization, optimization, and scale-up can support successful GMP manufacturing and productive long-term cooperative relationships with pharmaceutical companies, institutions, and universities.
Introduction
Antibody-drug conjugates (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.
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.
Our Services
- Contract Research and Development
The therapeutic effect of ADC drugs is affected by various factors; thus, rational design and selection of antibodies, small molecule drugs, linkers in the initial stage of ADC drug development are critical for the entire development process. BOC Sciences provides the most advanced and comprehensive ADC biopharmaceutical contract research and development services according to project research needs and supports our customers in discovering the most suitable ADC drugs.
- GMP Chemical Manufacturing
Based on our extensive experience with organic synthetic chemistry and R&D in GMP environments, BOC Sciences supports GMP-scale route design as well as optimization for payloads and payload linkers, including the use of HPAPI products.
The conjugation method between antibody, linker, and cytotoxin will affect the drug antibody coupling ratio (DAR) and the uniformity of ADC drugs, thereby affecting the biological activity, tolerance, and drug stability. Generally, the ideal DAR is 2-4. To match your ideal DAR, BOC Sciences provides ADC drug conjugation methods, including random conjugation and site-specific conjugation.
Impurities related to the ADCs specific process include unbound payloads, free linkers, or other chemicals used in the manufacturing process. For product-related impurities, such as polymers, fragments, charge variants and other PTMs on antibodies, BOC Sciences can adapt SEC, analytical ultracentrifugation, CE, capillary isoelectric focusing, ion-exchange chromatography and peptide maps for evaluation. Nevertheless, BOC Sciences uses advanced filtration equipment, such as ultrafiltration and tangential flow filtration (TFF) systems to remove therapeutic impurities and achieve optimum purification.
- ADCs Filling
After verifying the small-scale conjugation scheme, complete ADC conjugation can be achieved in a GMP-certified reactor. ADC products are purified using a disposable chromatography system and filled into sterile vials through a GMP aseptic filling pipeline.
Our Lab Equipment
| AD Systems and Equipment | QC Lab Systems and Equipment | |
| HPLC 2DHPLC | Instrument Group | HCP |
| Bio-LC | SEC-HPLC | Residual Host Cell DNA |
| cIEF (iCE3) | cIEF | Residual 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 Group | Endotoxin |
| Flow Cytometry | Cell-based Bioassay | Sterility |
| GC | ELISA / Western Blot | Water Testing |
| qPCR instruments | Trypsin Inhibitory Activity | Environmental Monitoring |
| 2DHPLC | SDS-PAGE (reduced and non-reduced) | Particulate Matter |
Our ADC Manufacture Workflow
Our Advantages
- High-quality, low-cost products
- Strict quality control
- Qualified facilities & equipment of cGMP laboratory
- Advanced ADC synthesis covering multiple chemical techniques
- Dedicated facilities and personnel for isolator processing, clean room manufacturing
- Development and manufacturing from gram to kilogram scales
- Regulatory support services
References
- Martin, C. et al. Antibody-drug conjugates: design and development for therapy and imaging in and beyond cancer, labex mabimprove industrial workshop. MAbs. 2017, 10(2): 210-221.
- Wiemer, A.J. et al. Stepping forward in antibody-drug conjugate development. Pharmacology & Therapeutics. 2021, 107917.
* Only for research. Not suitable for any diagnostic or therapeutic use.
