BOC Sciences has established a comprehensive and integrated preclinical research support platform, covering the entire process from ADC molecule design, structural characterization, pharmacodynamics and pharmacokinetics studies, safety and toxicology evaluation, to CMC documentation preparation. We have assembled a multidisciplinary team of experts in biology, pharmacology, toxicology, chemical analysis, and regulatory submission, and are equipped with advanced bioanalytical and mass spectrometry platforms to ensure that research data is scientifically rigorous and compliant with international quality standards such as GLP/GMP. With core advantages in flexible customization, efficient collaboration, and regulatory compliance, BOC Sciences provides reliable and high-quality preclinical ADC research solutions to global biopharmaceutical clients, accelerating the development and submission of next-generation ADC drugs.
ADCs exhibit high structural heterogeneity, including variable drug-to-antibody ratios (DAR), widespread conjugation site distribution, and complex impurity profiles, making quality control highly challenging. BOC Sciences utilizes multi-platform joint analytical approaches to comprehensively characterize ADC structures, ensuring batch-to-batch consistency and compliance with submission requirements.
ADCs undergo multiple in vivo processes influenced by various factors, leading to high variability in pharmacokinetic parameters and difficulties in accurately establishing PK/PD models. We offer end-to-end services from quantitative analysis to PK/PD modeling to support precise evaluation of in vivo behavior and therapeutic effects.
ADCs may induce toxicities in the liver, kidneys, and hematopoietic system. Traditional toxicological assessments are often insufficient to fully evaluate complex toxicity risks. BOC Sciences conducts systematic toxicology studies on our GLP-compliant platform, designing personalized protocols to identify potential off-target effects and optimize candidate molecules.
Combining the attributes of both proteins and small molecule drugs, ADCs present extensive and technically intricate CMC documentation requirements. We offer one-stop CMC support services, including analytical method validation, process control, and CTD documentation, enhancing the likelihood of successful submissions.
Before advancing an ADC program into the clinical stage, a series of preclinical studies must be completed to confirm its safety, efficacy, and pharmacokinetic characteristics. BOC Sciences offers comprehensive preclinical support services to facilitate successful IND submissions.
BOC Sciences provides highly sensitive and reproducible analytical methods for comprehensive ADC structural characterization, including:
These analyses provide critical data for establishing consistency, stability, and quality standards of ADC products.
ADC PK/PD studies must cover the release, distribution, and metabolism of their multi-component nature in vivo. BOC Sciences provides services including:
By building accurate PK/PD models, BOC Sciences helps clients predict clinical dosing ranges and therapeutic windows.
BOC Sciences offers complete design and execution services for ADC toxicology research programs, including:
These studies provide robust data to support IND submissions.
BOC Sciences conducts a series of in vitro functional studies to elucidate ADC mechanisms of action, including:
These studies validate ADC activity and provide feedback for drug optimization.
BOC Sciences has established various animal models suitable for ADC evaluation, including:
Combined with imaging monitoring and endpoint indicator analysis, these models enable high-quality pharmacodynamic validation.
BOC Sciences is well-versed in international CMC regulatory requirements and can assist clients with:
Helping projects successfully pass preclinical reviews by regulatory agencies such as the FDA and EMA.
BOC Sciences boasts an interdisciplinary team of experts across biology, pharmacology, toxicology, analytics, and CMC. This allows for rapid response to project needs, providing full-process technical support from target validation to IND submission, enabling efficient and collaborative project advancement.
Equipped with cutting-edge instruments such as high-resolution mass spectrometry, flow cytometry, and multifunctional imaging systems, we support structural characterization, bioanalysis, and pharmacological evaluation to ensure data accuracy, reproducibility, and completeness for regulatory submission.
According to the client's project stage and technical requirements, we offer tailored research solutions from lead screening and in vitro/in vivo evaluation to CMC support, meeting diverse service needs across different ADC development timelines and scales.
We strictly implement GLP, GMP, and other quality management systems, covering laboratory procedures, data management, and report delivery, ensuring research data is authentic, traceable, and compliant with preclinical submission standards of major regulatory agencies.
Based on client requirements and project stage, we evaluate the characteristics of ADC candidate molecules and customize scientifically sound research plans, clarifying key milestones and technical pathways.
We conduct analyses such as DAR, DAR distribution, and purity, utilizing multi-platform approaches to comprehensively characterize ADC structures and ensure compliance with regulatory requirements.
We evaluate ADC functionality through cytotoxicity assays, target binding, and internalization studies, verifying its targeting specificity and biological activity.
We perform PK/PD modeling, as well as acute and chronic toxicity studies, to systematically assess in vivo behavior and safety, supporting the optimization and selection of drug candidates.
Using xenograft or humanized models, we assess in vivo efficacy to confirm the anti-tumor activity of ADCs in animal systems.
We conduct process scale-up, quality standard establishment, and CTD documentation writing to support the preparation of CMC modules required for IND filing, enhancing the likelihood of successful registration.
Yes. We conduct functional validation experiments at the cellular level, including target binding, intracellular trafficking, toxicity analysis, and receptor-mediated endocytosis, to assess the biological activity and targeting specificity of ADCs, providing a basis for subsequent animal studies.
Yes. We possess extensive experience in animal experiments and bioanalysis, capable of conducting pharmacokinetic studies of monoclonal antibodies, toxins, and whole conjugates. We construct PK/PD models to support dose optimization and clinical strategies with scientific data.
Yes. Our toxicology research platform complies with GLP standards and covers acute toxicity, repeated dose toxicity, immunogenicity, and histopathological evaluation. Study protocols are designed according to ICH, FDA, and other guidelines, supporting IND submission.
Yes. We offer CMC-related services such as analytical method development and validation, process stability studies, and quality standard establishment, and assist in writing CTD module documentation to help clients efficiently prepare for registration and submission.
We are equipped with advanced analytical instruments such as mass spectrometry, HPLC, SEC, and CE, and adopt multi-dimensional combined analytical methods to systematically evaluate quality attributes including drug-to-antibody ratio, conjugation sites, purity, and aggregates, ensuring scientific and authoritative characterization of ADCs.
Absolutely. We flexibly design research content and timelines based on the client's project stage—whether in lead screening, candidate evaluation, or submission preparation—to ensure precise resource allocation and efficient data output.
Yes. We offer a full-service package covering ADC construction, in vitro and in vivo activity validation, PK/PD research, safety and toxicology evaluation, as well as CMC documentation preparation and submission support, fulfilling clients' one-stop preclinical development needs.
