Antibody Drug Development

Compared to small-molecule drugs, antibodies are more effective and have fewer side effects, making them one of the most successful candidates for new drug development. Monoclonal antibodies (mAbs) are an important biologic agent that are immune system proteins created in the laboratory. Because of their ability to bind to very specific targets, they can be designed as alternative antibodies to restore, strengthen, or mimic the immune system's attack on a variety of diseases. In addition, bispecific antibodies are developing rapidly, and scientists have developed new technologies capable of efficiently combining antibodies to two targets organically. A growing body of clinical data indicates that antibody-based biologics have potential as therapeutic agents for the treatment of serious infections. BOC Sciences offers unique technologies to increase protein and antibody product yields, reduce process development time, and improve product stability

Figure 1. Anatomy of therapeutic monoclonal antibodies (tmAb). (Raffaella, G.; Giacomo, O. et al. 2014)

Our Services

To make it easier and better for researchers, BOC Sciences provides antibody drug 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. Our well-established antibody drug development platform enables us to provide the following services such as vector construction, stable mammalian cell line generation, small and large transient production, upstream and downstream process development and scale-up, media selection, feed strategy optimization, assay development, product characterization and cGMP production. Our comprehensive expertise allows us to provide purified products with all relevant key biochemical and analytical characterization data

Upstream Process Development

Our team has developed robust and efficient production processes including initial purification development and cell culture process optimization

Downstream Process Development

BOC Sciences has developed a mature antibody purification platform process that allows for rapid establishment of a production process with acceptable product characteristics, process and product-related impurities

• Chromatography

Affinity chromatography (AC), Ion exchange chromatography (IEX) and Hydrophobic Interaction Chromatography (HIC)

• Filtration and centrifugation

Deep filtration, Tangential flow filtration (TFF) and Ultrafiltration and liquid exchange

• Virus inactivation and removal

Low pH inactivation and detergent treatment, Nanofiltration (NF) and Chromatographic analysis

Antibody Affinity Maturation

• We use phage and yeast surface display platforms for high throughput screening to improve the target binding affinity
• CDR randomization of different antibody fragment scaffolds (scFv, Fab, VHH)
• Large single or large combined variable heavy/light chain yeast or phage display CDR libraries can be generated
• Kinetic characterization of antibodies using state-of-the-art instrumentation

Antibody Humanization

• BOC Sciences has developed an efficient complementarity-determining region (CDR) grafting platform which can transfer the antibodies (CDRs) into the appropriate human antibody framework while retaining their original affinity and specificity. Our experts are able to calculate a monoclonal antibody humanness score to distinguish between human and non-human antibodies
• Humanization workflow: Sequence analysis→Generation of humanized variants→Variants analysis

Hybridoma Services

• BOC Sciences' in vivo discovery immunology team offers high-performance hybridoma-based technologies to help clients discover the most promising antibodies
• We use ELISA and FACS-based high-throughput screening and hybridoma off-rate analysis of hybridomas to study the specificity, cross-reactivity and functionality of candidate antibodies
• Diverse therapeutic and clinical diagnostic/imaging antibody candidates against immuno-oncology targets, GPCRs, neurobiology targets, enzymes

Figure 2. Cross-reactivity of polyclonal rabbit anti-tmAb antibodies to polyclonal human antibodies. (Raffaella, G.; Giacomo, O. et al. 2014)

Phage and Yeast Display Platform

• BOC Sciences offers phage and eukaryotic-based yeast display platforms for in vitro discovery and design of potent antibody candidates for therapeutic or diagnostic use
• Selection of high affinity functional antibodies against conventional or challenging targets using custom state-of-the-art libraries

Complete Antibody Characterization

• Affinity analysis

We can determine the kinetic properties of antibody-antigen interactions of test antibodies or antibody-fragments as purified or non-purified samples. In addition, BOC Sciences supports high-throughput array SPR , BLI platform and epitope binning

• FcRy and FcRn binding assays

BOC Sciences has introduced the BLI platform in a high-throughput format to establish a standard human Fcγ receptor panel binding assay to measure the affinity of antibodies to the Fcγ receptor, thus predicting biological and pharmacological outcomes such as cytotoxicity or half-life

• Sequence liability identification

Our team has designed complex algorithms to identify sequences within variable regions of antibodies that could be potentially responsible for product quality. Our reliable sequence liability identification service can help assess whether they need to be eliminated early in the engineering process and select liability-free antibodies for further development

• In silico Immunogenicity prediction

Our in silico immunogenicity prediction service provides a cost-effective preliminary analysis of the immunogenicity of the biologics against major MHC class II alleles

Therapeutic Developability Analyses

BOC Sciences supports a range of therapeutic developability assessments including biophysical and chemical characterization of drug candidates. In silico prediction tools and a range of rapid and small-scale assessments are employed as additional selection criteria for better and safe therapeutic leads

• In silico sequence liability analysis
• In silico immunogenicity analysis
• Polyspecificity assessment
• Integrity and stability assessment
• Buffer exchange
• Forced degradation
• Integrity and stability Assessment
• Additional pressure conditions

Figure 3. Cross-reactivity of polyclonal rabbit anti-tmAb antibodies to other tmAbs. ((Raffaella, G.; Giacomo, O. 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 antibody drug development at competitive prices for global customers. Personalized and customized services of antibody drug 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

1. Groerichter-Wagener, C.; Kos, D. et al. Biased anti-idiotype response in rabbits leads to high-affinity monoclonal antibodies to biologics. 2020. 12(1): e1814661.