ADC Process Development
Nowadays, unlike conventional therapeutic approaches, antibody-drug conjugates (ADCs) have been developed as an emerging class of therapeutic method that exploits the binding specificity of antibodies to produce highly effective drugs. there is a great diversity in the design of ADC molecules, and an ADC consists of an ideal monoclonal antibodies (mAbs), an active cytotoxic drug and a suitable linker. Unlike chemotherapy, ADCs are designed to target and kill only cancer cells, while preserving healthy cells. Compared to conventional drugs, they have a rather complex structure. Therefore, the development and subsequent manufacturing of ADCs is more challenging. BOC Sciences has extensive expertise in the development of biologics, our expert team possesses extraordinary experience and capabilities in the development of ADCs and other polymer-drug conjugates.
Advantages of ADC
- Highly targeted and efficient cancer therapy
- Therapeutic potential for infectious diseases, inflammatory conditions and autoimmune diseases
Figure 1. Critical factors that influence ADC therapeutics. (Panowski, S.; Bhakta, S. et al. 2014)
Our Services
To make it easier and better for researchers, BOC Sciences provides ADC process development service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs. BOC Sciences is one of the world's leading companies in ADC drug development, providing technical challenges from development to commercial production. Our first-class services can greatly accelerate the ADC drug development process.
ADC Development Process
At BOC Sciences, the ADC production process consists of three distinct phases: functionalization of the antibody, conjugation reaction, and downstream purification and formulation steps:
mAb dilution→Reduction→Conjugation and quench→Purification/Chromatography→Ultrafitration/Defiltration→Final filtration and botting→Formulated ADC
ADC Development
- Preliminary proof-of-concept (PoC): Evaluate different loads, connectors, and engagement strategies to develop an ADC that fits your needs
- Antibodies/Targets: Various splicing methods, including cysteine, lysine and enzymes, different dar conjugates, multiple toxins available, cuttable and non-cuttable junctions
- Customer payloads: Model antibodies, novel payloads for junction design
- Scaling, purification and analysis: Hundreds of milligram scales, membrane and chromatographic purification, certified ADCs: micro, monomer, concentration and residual toxins, other analyses including mass spectrometry, IEF, CE-SDS endotoxin, bioburden
ADC Analytical Services
We use multiple analytical characterization to ensure product integrity and manufacturing consistency. Our team selects the appropriate analytical technique depending on the linker properties, the drug and the choice of the linker site. At BOC Sciences, common analytical methods are used to evaluate the physicochemical and biophysical properties of ADCs
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Figure 2. ADCs expand the therapeutic window. (Panowski, S.; Bhakta, S. et al. 2014)
Process Scale Up
- Formulation development studies
- Optimization of conjugate chemistry
- Development and optimization of supporting purification technologies
- Robustness and process characterization studies
- Experience with conjugation chemistry for non-cleavable, cleavable and enzyme-labeled linkers
- Experience with major drugs: Auristatins, methionine analogs, dicarbonyl compounds, pyrrolobenzodiazepines
ADC Manufacturing
- Clinical and commercial-scale GMP manufacturing suites
- Chromatographic purification capabilities
- Up to 1000L reactive volume capability depending on the complexity
- Dedicated or single-use product-contact manufacturing components
- Handling capability for derivatives or analogs of highly potent cytotoxic agents or natural and synthetic origin: auristatin, maytansanoids, duocarmycins, and others
Figure 3. ADC metabolism in vivo. (Panowski, S.; Bhakta, S. et al. 2014)
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of ADC process development at competitive prices for global customers. Personalized and customized services of ADC process development can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Panowski, S.; Bhakta, S. et al. Site-specific antibody drug conjugates for cancer therapy. Mabs. 2014. 6(1): 34-45.
