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Antibody–Drug Conjugate Solutions

Antibody–Drug Conjugate Solutions

BOC Sciences is committed to providing one-stop antibody-drug conjugate (ADC) solutions to global customers, covering the full service chain from early discovery and process development to preclinical research. Leveraging advanced technology platforms, a rich library of toxins and linkers, an experienced R&D team, and a high-standard quality control system, we offer solid support for the rapid development and translation of ADC drugs. Through standardized and modular service processes, we ensure high controllability and transparency for each project. BOC Sciences not only has the capability to efficiently construct ADC prototypes but also enables a smooth transition from laboratory scale to pilot production, accelerating the clinical advancement of candidate molecules. We are your trusted partner in ADC development.

Key Challenges in Antibody–Drug Conjugate Development

Comprehensive  Product Line

Complexity in Target Selection and Antibody Design

Target screening and antibody design have high entry thresholds, which impact the targeting and internalization efficiency of ADCs. BOC Sciences has a mature antibody screening and humanization platform that enables the customization of high-affinity, low-immunogenicity antibody molecules to enhance targeting performance.

Competitive  Pricing

High Difficulty in Linker Design

The design of linker structures is complex and determines the precision of drug release and pharmacological safety. We offer various types of cleavable linkers and non-cleavable linkers and support intelligent structural optimization to ensure good stability and controllable release performance of ADCs in vivo.

Flexible  Ordering Options

Toxicity Risks in Payload Drug Development

Payload drugs are highly toxic, and their synthesis and handling require strict safety controls. BOC Sciences possesses a mature platform for the synthesis of highly potent molecules and a safe operating system, supporting kilogram-scale custom synthesis and purification of various cytotoxins.

Strict  Quality Control Testing

Conjugation Process Impacts DAR and Homogeneity

The conjugation process imposes stringent requirements on drug-to-antibody ratio (DAR) control and molecular homogeneity. We have developed multiple conjugation strategies and DAR optimization technologies to precisely control drug loading and conjugation sites, thereby improving product consistency and stability.

Integrated ADC Development Solutions by BOC Sciences

In response to the characteristics of ADC projects, BOC Sciences has built an integrated development framework encompassing early discovery – process development – preclinical research. With technological depth and platform integration at its core, we help clients address challenges across the entire ADC R&D pipeline.

ADC Early Discovery

Target Analysis and Antibody Screening

  • Provides various antibody sources (mouse, rabbit, humanized, etc.).
  • High-affinity screening and antibody engineering (e.g., Fc optimization, deglycosylation).

Linker and Payload Screening

  • Linker types include reduction-sensitive, enzyme-cleavable, and acid-sensitive types.
  • Payload drugs include MMAE, DM1, SN-38, PBD, duocarmycin, and more.

Conjugation Strategy Development

  • Provides Lys, Cys site conjugation, and site-specific conjugation.
  • DAR control range supports adjustable ratios from 2–8, balancing uniformity and activity.

Prototype ADC Construction and Functional Validation

  • Rapid synthesis of prototype molecules for cytotoxicity, specific targeting, and preliminary stability testing.
  • High-throughput platform supports parallel screening of multiple candidate molecules.

ADC Process Development

GMP Material Development

  • Establishes large-scale antibody expression systems (CHO, HEK293).
  • Kilogram-scale synthesis and purification of drug carriers and linker materials.

Conjugation Reactions and DAR Control

  • Establishes reproducible, scalable, and stable conjugation processes.
  • Optimizes reaction conditions for high yield, low impurities, and minimal free drug residues.

Purification and Formulation Development

  • Develops multiple purification methods such as HIC, SEC, IEC.
  • Provides formulation stability optimization for both liquid and lyophilized forms.

Analytical Method Development

  • Establishes a complete quality control system: HPLC, CE, LC-MS, ELISA, etc.
  • Ensures compliance from early validation through IND filing.

ADC Preclinical Research

In Vitro Pharmacology and Mechanism Studies

  • Multidimensional pharmacological validation including cytotoxicity, cell uptake, and target expression.
  • Mechanism of action studies such as cell cycle arrest and apoptosis pathway analysis.

In Vivo Pharmacology and PK/PD

  • Establishes xenograft and PDX mouse models.
  • Full PK analysis methods for ADC, free drug, and antibody.

Toxicology Studies

  • Single-dose and repeated-dose toxicity studies.
  • Systematic evaluation of immunogenicity, hematology, and histopathology.

Regulatory Filing Support

  • Provides CMC documentation writing and pharmacokinetic/toxicological data analysis.
  • Assists clients in IND registration and technical consultations.

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Core Capabilities of Our Advanced ADC Platforms

Based on years of biopharmaceutical experience, BOC Sciences has built an integrated ADC R&D engine that covers all aspects from molecular design and critical raw material preparation to conjugation strategy development and analytical quality control. Our platform is highly flexible, supporting both customized development and high-standard industrial production, greatly improving the efficiency and controllability of ADC projects.

Diverse Linker Chemistry Platform

As a critical factor in ADC efficacy, safety, and stability, BOC Sciences has established a chemistry platform encompassing cleavable linkers (e.g., acid-sensitive, enzyme-cleavable, reduction-sensitive) and non-cleavable linkers, with full-service capabilities from design and synthesis to purification. We also support customized linker structures to meet client needs for precise drug release.

Highly Potent Payload Synthesis Platform

For commonly used microtubule inhibitors (e.g., MMAE, DM1) and DNA-damaging agents (e.g., PBD, Calicheamicin), BOC Sciences provides complete systems for synthesis, modification, storage, and handling, accommodating process scale-up from milligram to kilogram levels. We can also assist clients with the targeted synthesis and functional validation of novel cytotoxic agents.

Diverse Conjugation Strategy Platform

BOC Sciences offers traditional Lysine conjugation, Cysteine conjugation, and site-specific conjugation strategies, as well as new techniques such as Enzymatic Conjugation (e.g., Transglutaminase, Sortase A) and Click Chemistry. Through DAR control and structural uniformity evaluation, we ensure ADCs with superior stability and predictability.

High-Throughput Analytical and Quality Control Platform

ADC development relies heavily on analytical characterization. BOC Sciences has established a complete ICH-compliant analytical system, including HPLC, LC-MS, HIC, SEC, UV, SDS-PAGE, etc., for comprehensive characterization of antibodies, linkers, drug loading (DAR), purity, aggregates, and free toxins. We also provide support for CMC development, including analytical method establishment and validation.

Scalable GMP-Compatible Production Platform

To support varying scale requirements from preclinical to clinical stages, BOC Sciences is equipped with advanced GMP-compliant facilities to support ADC pilot scale-up, raw material batch preparation, process transfer, and small-scale production. Our production system complies with US FDA and EMA standards, ensuring a solid foundation for clients' subsequent IND/CTA submissions and clinical advancement.

Innovative ADC Development Platforms

BOC Sciences has developed a range of next-generation ADC platforms, including FDCs, BsADCs, DACs, dual-payload, NDCs, and SDCs. These platforms support customized structures, linker screening, and payload strategies, enabling tailored solutions for diverse targets and indications while enhancing the precision and innovation of ADC candidates.

Service Advantages and Capabilities

01

Integrated Platform Support Covering Full-Process Development

We have established a comprehensive end-to-end platform encompassing target discovery, antibody screening, linker design, payload synthesis, conjugation process, and quality analysis, providing one-stop ADC development services.

02

Robust Custom Development Capabilities

We tailor molecular structures, conjugation methods, and process parameters according to client project requirements, supporting diverse conjugation strategies and highly potent drug structures to achieve differentiated ADC designs.

03

Advanced Analytical and Characterization Technologies

Equipped with high-throughput analytical instruments and a well-established methodological system, we comprehensively support the characterization and control of key quality attributes such as DAR determination, purity analysis, and impurity identification.

04

Safe Synthesis System for Highly Potent Molecules

We operate dedicated facilities for the synthesis of highly potent drugs and possess extensive experience and safety management procedures for handling toxic and reactive compounds, ensuring operational compliance and product quality.

05

Efficient Project Management and Rapid Response Mechanism

Our experienced project management team maintains effective communication with clients, ensuring clearly defined milestones, controllable progress, and rapid response to technical changes and development needs.

06

GMP-Compatible Capability for Clinical Applications

We support process transfer and pilot production from preclinical to clinical sample preparation and provide a GMP-compliant system to robustly support clients' IND/CTA filings.

Service Process Overview: One-Stop Delivery

Scheme Design and Contract Customization

Case Design and Evaluation

Based on client goals and our accumulated technical database, we formulate customized ADC development plans. Through cross-assessment of target expression, linker types, and payload stability, we provide scientific guidance and risk prediction for subsequent experiments.

Payload/Linker Synthesis

Early-Stage Construction and Screening

We rapidly construct multiple ADC prototype molecules and conduct DAR control, conjugation efficiency testing, and in vitro cytotoxicity screening to preliminarily validate druggability and structural feasibility of candidate molecules.

Scheme Design and Contract Customization

Process Development and Scale-Up

For the preferred ADC molecule, we optimize the conjugation process through systematic studies on parameters such as reaction conditions, raw material purity, and batch consistency. This ensures scalability and supports small-scale pilot preparation.

Analysis, Purification and Characterization

Quality Analysis and Verification

Utilizing high-standard analytical platforms, we conduct comprehensive quality evaluations covering purity, aggregates, free drug, DAR, residual solvents, and more. This is accompanied by the establishment and validation of analytical methods to meet regulatory requirements.

cGMP Manufacturing and Filling

Efficacy/Toxicity Studies

We assist clients in conducting in vivo efficacy evaluations and preliminary toxicological studies of ADC molecules, providing data on therapeutic efficacy and toxic side effects to support clinical development.

Result Delivery

IND Filing Support

With our GMP-compliant processes, standardized analytical methods, and comprehensive research documentation, we offer technical support for IND submissions, including preparation of CMC documents, process control summaries, and analytical method validation data.

Frequently Asked Questions

Frequently Asked Questions

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