BOC Sciences specializes in the process development and optimization of antibody-drug conjugates (ADCs). With an advanced technology platform and an experienced scientific team, we provide global clients with one-stop customized services from proof-of-concept to GMP production. Our mature conjugation technology system covers various types of linker-payloads and conjugation strategies, enabling precise DAR control and enhancing product stability and consistency. Through modular development processes, high-standard analytical systems, and stringent quality control, BOC Sciences is committed to accelerating the development of ADC candidate molecules, minimizing process transfer risks, and providing regulatory support compliant with international standards such as FDA/EMA. Our professional capabilities serve as a solid foundation for the efficient advancement and successful submission of ADC projects.
Wide DAR distribution can lead to fluctuations in efficacy and toxic side effects. We achieve precise DAR control and batch-to-batch consistency through customized conjugation strategies and real-time analytical techniques.
If the linker is chemically unstable or has uncontrollable degradation, drug release efficiency will be affected. BOC Sciences designs intelligent linkers to achieve a balance between blood stability and controlled release within tumors.
Difficulty in controlling drug loading or instability during scale-up may hinder process translation. BOC Sciences has established a modular drug-loading platform to ensure DAR is controllable and reproducible at different scales.
Lab-scale processes often lose efficiency or product purity during scale-up. We provide comprehensive process characterization and parameter window studies to ensure consistent conjugation efficiency and purification during scale-up.
In the ADC process development stage, the goal is to transform candidate molecules screened in early discovery into products suitable for large-scale production, ensuring process stability, reproducibility, and production efficiency. BOC Sciences understands the importance of process development for the final quality and commercial success of ADCs. With years of experience in biologics development, advanced equipment, and a rigorous quality management system, we tailor a complete set of scientific and efficient process development solutions for clients, covering key aspects such as conjugation process optimization, purification process establishment, formulation development, and process scale-up.
The primary task of process development is to optimize conjugation reaction conditions to achieve the target DAR and uniform product distribution. BOC Sciences designs systematic experiments for different conjugation strategies (e.g., random conjugation, site-specific conjugation), adjusting key parameters including:
Purification is a core step to ensure ADC quality, directly affecting product safety and efficacy. BOC Sciences is equipped with various advanced purification instruments, including Protein A columns, ion exchange columns, hydrophobic interaction columns, and size exclusion columns, allowing flexible combination of multiple purification strategies for efficient separation.
Given the complexity and variability of ADC structures, rational formulation design is particularly critical. BOC Sciences offers comprehensive formulation optimization services, including buffer systems, stabilizers, pH adjustments, and preservative screening, to ensure ADC stability and activity during storage and transport.
The ultimate goal of successful process development is to enable smooth scale-up from lab to pilot and even commercial production. BOC Sciences offers a range of reactors and purification equipment from 1 L to 1000 L, supporting process scale-up and continuous manufacturing process development.
BOC Sciences has a multidisciplinary team in organic chemistry, protein engineering, analytical science, and biologics. This enables effective integration of antibody engineering, linker synthesis, toxin chemistry, and analytical method development.
BOC Sciences operates GMP manufacturing facilities that meet international standards, equipped with strict quality management systems and audit compliance capabilities, supporting production from preclinical to NDA stages.
Equipped with advanced chromatography and membrane separation systems, we apply the QbD approach for process parameter window studies to achieve efficient separation, remove free toxins and process impurities, and ensure smooth GMP scale-up.
Compared to large multinational CDMO platforms, BOC Sciences offers cost-effective service solutions with rapid response and flexible project execution models to help clients control R&D costs and improve overall efficiency while ensuring quality.
Yes, BOC Sciences supports client-supplied antibodies, linkers, or payload materials. We can customize the process development plan based on material characteristics and also assist in optimizing material purity, solubility, and compatibility to improve conjugation efficiency and product quality.
We support various ADC conjugation strategies, including lysine-based, cysteine-based, glycosylation site modification, and click chemistry. Based on the antibody structure and payload properties, we can recommend the optimal conjugation method to achieve high efficiency, controllable DAR, and good stability.
Yes, we offer process scale-up services from laboratory to pilot scale (10–100 L). Through systematic process parameter optimization and scale-up verification, we ensure the feasibility and reproducibility of the subsequent GMP transfer.
We provide comprehensive ADC analytical method development and validation services, including DAR determination, purity analysis, aggregate detection, and free toxin residue analysis, to meet quality control and regulatory filing requirements and support IND or clinical research submissions.
We are equipped with cGMP-compliant production facilities and can collaborate with GMP partners to complete small-scale validation and commercial production. All pilot-scale and GMP-transfer data can support regulatory filings and technical transfers.
Yes, we support the development of complex ADC structures such as bispecific antibody ADCs, polymer-based ADCs, and small molecule conjugates. We possess the platform and experience to handle various molecular designs and conjugation challenges.
A typical ADC process development cycle takes approximately 8–16 weeks, depending on antibody complexity, payload type, and analytical method requirements. We also offer accelerated development options to meet clinical or regulatory submission timelines.
