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ADC Manufacturing: Core Principles & Key Challenges
An Antibody-Drug Conjugate (ADC) is a complex yet highly targeted biopharmaceutical composed of a monoclonal antibody, a cytotoxic payload, and a chemical linker.
Manufacturing an ADC is a multi-step, interdisciplinary process where success hinges on the precise and stable conjugation of these three components while preserving the antibody's biological activity and the payload's cytotoxicity.
Key Challenges in ADC Manufacturing
Precision in Conjugation
Accurately controlling the drug-to-antibody ratio (DAR) is fundamental to ensuring product homogeneity and therapeutic efficacy.
Handling of Highly Potent Payloads
Many ADC payloads are highly potent active pharmaceutical ingredients (HPAPIs) that require handling in strictly controlled and contained cGMP environments to ensure operator and environmental safety.
Comprehensive Quality Control
The complex structure of ADCs necessitates the development of robust analytical methods to assess purity, stability, conjugation efficiency, and biological activity.
Process Scale-Up and Consistency
Scaling the process from the lab to commercial production is challenging and requires rigorous validation to ensure consistent product quality across all batches and scales.
Our Comprehensive ADC Manufacturing Services
cGMP Antibody Production
A high-quality monoclonal antibody is the cornerstone of a successful ADC. We offer cGMP-compliant antibody development and manufacturing, including stable cell line development, upstream culture optimization, and downstream purification process development, to provide you with high-purity, high-yield antibody material with excellent batch-to-batch consistency.
cGMP Organic Synthesis
Creative Biolabs provides customized chemical synthesis service and fine chemicals based on our well-established organic synthesis chemistry pipeline in R&D and cGMP environments. This pipeline enables us in preparing regular or highly tailored linker molecules bearing different release mechanisms, modifying payload drugs for proper conjugation chemistry, preparing new payload derivatives for the purpose of drug development, and formulating the drug-linker complex for ADC manufacturing.
ADC Conjugation, Purification, and Filling
ADC conjugation is achieved in cGMP certified reactors after small-scale conjugation protocol verification. The therapeutic impurities are removed utilizing advanced filtering devices such as ultrafiltration and tangential flow filtration (TFF) systems. The ADC product are purified using single-use chromatography systems and finished by filling into aseptic vials via the cGMP sterile filling pipeline.
Our Advanced ADC Technology Platforms
Site-Specific Conjugation Technology
We employ enzymatic (e.g., Transglutaminase) and chemical methods to achieve precise drug conjugation at specific sites on the antibody, resulting in homogeneous ADCs with a consistent DAR.
Advanced Linker Technology
We offer a diverse portfolio of stable and cleavable linkers to accommodate various drug-release mechanisms and therapeutic requirements.
High-Efficiency Purification Platform
Our platform integrates advanced techniques like Tangential Flow Filtration (TFF) and Hydrophobic Interaction Chromatography (HIC) to efficiently remove unconjugated antibodies and free payloads, achieving product purity of over 99%.
High-Potency API (HPAPI) Handling
We operate with OEB 4/5-rated isolators and specialized personal protective equipment, guaranteeing the safe and compliant handling of highly potent and cytotoxic substances.
Our Streamlined ADC Manufacturing Workflow
Our workflow is meticulously designed to ensure transparency, efficiency, and high-quality delivery.
Assessment
Development
Analytics
Scale-Up
cGMP
Delivery
Project Initiation & Assessment
The client provides the antibody, payload, and technical requirements. We conduct a thorough technical evaluation and feasibility analysis.
Process Development
We develop and optimize the conjugation and purification processes at the lab scale to define critical process parameters.
Analytical Method Establishment
We develop and validate a complete set of analytical methods for in-process control and final product release.
Pilot Scale-Up & Tech Transfer
The lab-scale process is transferred to the pilot production suite for process validation and scale-up studies, producing material for toxicology studies.
cGMP Manufacturing
Clinical or commercial batches are manufactured in a fully validated cGMP environment.
Quality Control, Release & Delivery
The final product undergoes comprehensive quality testing. QA releases the batch upon confirmation that all specifications are met. We deliver the final product along with a complete batch record and certificate of analysis.
Why Choose Creative Biolabs for ADC Manufacturing?
End-to-End, One-Stop Solution
We simplify your supply chain by offering integrated services from antibody production and conjugation development to cGMP manufacturing and aseptic fill/finish.
World-Class Quality System
We strictly adhere to ICH, FDA, and EMA guidelines. Our robust quality management system is embedded in every step of the ADC manufacturing process.
Leading Scientific Expertise
Our team consists of scientists and engineers with over a decade of dedicated experience in the ADC field, ready to tackle any technical challenge.
Unmatched Flexibility
We offer flexible and customized service plans to meet your needs, whether for small batches for early-stage R&D or large-scale production for late-stage clinical trials.
State-of-the-Art Facilities
We have invested in cutting-edge manufacturing and analytical equipment, including specialized isolators for handling HPAPIs, to ensure project success.
Trusted by Leading Researchers & Companies
What Our Clients Say
Case Studies
Antibody Internalization Assay
With the success of these case studies, various approaches have been proven helpful in detecting internalization efficiency and are elucidated in this brochure.
- Case 1: Internalization of anti-HER2 mAb-vc-Toxin
- Case 2: Trafficking of anti-HER2 mAb and anti-HER2 mAb-vc-MMAE
- Case 3: Internalization kinetics of anti-Trop mAb-vc-auristatin
Anti-HER2 ADC Preparation & Potency Evaluation
This case study delves into key aspects such as optimized strategies for HER2 antibody selection, linker-payload conjugation techniques, in vitro and in vivo potency assessment data, and solutions to challenges encountered during development.
- Introduction
- Materials and Methods
- Results
Custom Synthesis of ADC Linker-payload SET
Presented here is a case study for the synthesis of two customized payload-linker complexes via the "DrugLnk" organic synthesis services, ranging from traditional payloads to novel warheads.
- Introduction
- SN38: a novel payload for ADC development
- Case 1: Mc-vc-PAB-SN38
- Case 2: CL2A-SN38
Frequently Asked Questions (FAQs) about ADC Manufacturing
Can you work with client-provided antibodies and payloads?
Yes, our primary service model involves working with materials provided by our clients. We conduct comprehensive quality checks on all incoming materials to ensure they meet production requirements. We can also provide one-stop services, including antibody production and linker/payload synthesis.
What are the minimum and maximum production scales you can handle?
Our services are highly flexible. We can handle production scales ranging from a few milligrams (for initial screening and research) to multiple kilograms (for late-stage clinical and commercial supply).
How long does a typical ADC cGMP manufacturing project take?
The project timeline depends on the project's complexity, scale, and the extent of process development required. A typical project, from process development to the delivery of the first cGMP batch, usually takes 6 to 9 months.
How do you ensure the safe handling of highly potent APIs (HPAPIs)?
We utilize state-of-the-art isolator technology and follow strict Standard Operating Procedures (SOPs). All operations involving HPAPIs are performed in a physically isolated, negative-pressure environment. Our operators are professionally trained and equipped with the highest level of personal protective equipment (PPE) to ensure the safety of personnel, product, and the environment.
What key analytical services do you provide post-conjugation to ensure product quality?
We provide a comprehensive suite of analytical services to characterize the final ADC product. This includes confirming the molecular weight with mass spectrometry (MS), assessing the drug-to-antibody ratio (DAR), purity, and aggregate content with various chromatography techniques (e.g., HIC-HPLC, SEC-HPLC), and verifying biological activity with cytotoxicity assays. We ensure every batch undergoes rigorous quality control and is delivered with a complete analytical report.
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