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BOC Sciences integrates the antibody-drug conjugate services to offer comprehensive one-stop antibody-drug conjugate research and evaluation services. As a research-oriented and customer-based company, we are committed to helping global customers expedite ADC drug development and manufacture cost-effectively. In BOC Sciences, our customers know us as a professional and attentive partner who delivers quality results, and our services are designed to ensure each project goal is met and exceeded.
Combining monoclonal antibodies (mAb) targeting cancer-specific antigen with cytotoxin has revealed great potential as a novel targeted cancer therapy. Antibody-drug conjugates (ADCs) are a new class of therapeutic agents that contain the targeting ability of mAbs with small molecular drugs. Due to the significant differences in ADCs drug designs, including the differences in recognition sites, connection sites, linker design, and small-molecule toxins, the ADCs drugs' overall efficacies and toxicities of the same target may not be the same. The complete development process of ADCs drugs from preclinical to clinical involves target verification, process characterization, preclinical efficacy and safety evaluation, pharmacokinetic model, clinical design, and efficacy evaluation.
Fig 1. Key components of an ADC (Pharmaceuticals, 2018, 11: 32).
A suitable selection of components is the key to successful ADCs development. In order to achieve specific delivery of a cytotoxic payload, target antigen must be highly expressed on the surface of tumor cells rather than the normal cells. Thus, conjugating mAbs to highly potent cytotoxic payloads facilitates site-specific delivery to the target cells and minimizes off-target rate cytotoxicity. Upon binding to the specific antigen, antibodies were absorbed through rapid internalization followed by lysosomal degradation and subsequently releasing cytotoxins inside the cell. As a result, ADCs can be used to deliver cytotoxic drugs to cancer cells.
With our state-of-the-art equipment and extensive R&D expertise, BOC Sciences can provide customized antibody modification and conjugation technologies with high specificity and affinity with a quick turnaround time. The conjugation method can directly affect the ADC's quality, thereby regulating the safety and efficacy of products. Some strategies for antibody modification and conjugation include:
BOC Sciences' ADC manufacturing platform provides various effective payloads development services ranging from laboratory scale (mg to g) to GMP production (kg). We provide payloads for various targets according to the needs of customers, including microtubule inhibitors, DNA inhibitors, RNA polymerase inhibitors, protein toxins, and enzyme toxins. Our payloads development services include:
ADCs are complex molecules with unique critical quality attributes (CQAs). In addition to the quality requirements for naked antibodies, which include drug antibody ratio (DAR), drug load distribution (DLD), unbound payloads or unbound antibodies number, antigen-binding, and cell viability, each CQA must be fully evaluated to ensure product quality and production consistency. The one-stop system BOC Sciences used to analyze and characterize the antibody-drug conjugate is divided into three modules, which measure the structural characterization, drug effect, and drug impurities of antibody-conjugated drugs to ensure comprehensive analysis and evaluation of ADCs structures and drug effects. Our quality assessment services include:
Linkers are essential parts of ADCs, which connect mAbs to payloads and stabilize circulation until ADCs reach target cells for payload releases. BOC Sciences offers flexible ADC linker product suites and development services at competitive prices. Large-scale linkers from kilograms are synthesized based on GMP, and laboratory-scale from milligrams to grams. Some linker types include but are not limited to non-cleavable linkers and cleavable linkers.
In the construction of ADCs, the specific combination of linkers and cytotoxins is most likely to differentiate the efficacy of ADC drugs and patented. As an experienced manufacturer in ADC conjugation and process amplification, BOC Sciences can supply mature linker and cytotoxic technology to accurately control the ADC coupling process in a GMP environment with complete QA/QC supervision.
BOC Sciences' custom GMP-grade antibody-drug conjugates (ADC) manufacturing services can meet clinical and commercial development needs and equip GMP and ISO-certified contract manufacturing facilities. Our ADC manufacturing solutions include GMP chemical manufacturing and ADC conjugation, purification, and filling.
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