BioDuro's antibody-drug conjugates (ADC) service platform is designed to support various approaches to ADC development from target identification to preclinical candidate (PCC). Our integrated ADC discovery services include:
Antibody development
ADC-related custom synthesis
Payload and linker catalog
Conjugation chemistry
In-vivo and in-vitro assays and DMPK services
Our platform is equipped to navigate the complexities of ADC development, with scalable capabilities that provide efficient and effective solutions for our clients.
Click here to download the PDF version of our ADC services flyer
In 2024, we successfully delivered 1,600+ novel payloads, leveraging our extensive experience in the synthesis and production of 10+ types of payloads for backbone modification to enhance activity, ADME/T, and drug resistance.
Camptothecin analogues
Rapamycin analogues
Adriamycin analogues
BCL-XL payloads
Auristatins
TLR7 payloads
Steroid payloads
TLR8 payloads
TLR7/8 payloads
Sting payloads
Duocarmycin analogues
Linker Synthesis and SAR Optimization for ADC
Our in-house custom synthesis services for ADC-related products are enhanced by a reliable vendor network which makes available 4,000+ linkers to BioDuro customers, including:
Peptide linkers
Click chemistry linkers
Disulfide linkers
Thioether linkers
Glucuronide linkers
PEG linkers
Versatile breakable linkers
Payload-Linker Synthesis
BioDuro's robust capabilities in payload-linker synthesis are enhanced by our comprehensive and systematic payload-linker library. Our payload-linker synthesis operations are supported by an in-house analytical team for quick turn-around time. Additionally, our expertise in SAR analysis directly informs the design and strategy of payload-linker synthesis, for example, by exploring novel cytotoxic agents and/or optimal link positions.
Case Study: Method optimize and shorten the synthesis route
Focused on each customer's unique project, our ADC synthesis team often modifies and builds upon the synthetic methods/routes described in literature. For example, in the synthesis of Int-A, the team optimized the route after reviewing various literature methods, resulting in a shorter reaction cycle and a corresponding product that is easier to purify.
Bioconjugation Discovery Service
BioDuro bioconjugation service capabilities cover various proteins, linker payloads, as well as conjugation technologies. We also provide a variety of site-specific conjugation methods in addition to the traditional Cysteine and Lysine conjugation methods to serve customers. These methods include: Thiomab (TDC), unnatural amino acid insertion, enzymatic coupling, etc.
In-Vitro & In-Vivo Efficacy Evaluation
BioDuro offers robust ADC in-vivo/in-vitro efficacy evaluation services, supported by 2AAALAC accredited vivarium facilities (1,600 m²) and access to 500+ cancer cell lines, including a wide range of ADC target protein positive and negative tumor cells. Additionally, we provide target overexpression cell line construction services and can perform bystander effect analysis for multiple known targets. Our team also has extensive experience in cell labeling and cell viability analysis using FACS.
ADC binding affinity (biochemistry, SPR, FACS)
ADC killing efficacy (CTG)
ADC bystander effect (FACS)
ADC internalization (FACS, Imaging by High Content Imaging or Incucyte)
ADCC assay (reporter gene assay, LDH)
ADCP reporter gene assay
Case Study: ADC internalization (Incucyte Imaging) - Click to enlarge the image
Alexa Fluor 647 Dye Profile: Incucyte® Human Fabfluor-pH Red Antibody Labeling Reagent
The imaging results highlight the ADC's kinetic internalization, indicating effective intracellular trafficking. This supports the ADC's potential for robust and kinetic therapeutic efficacy.
Our company is well equipped with a diverse library of 300+ validated CDX models and 100+ validated PDX models for ADC drug development. This extensive collection supports robust pre-clinical research across various cancer types, enabling us to efficiently evaluate drug candidates and accelerate the R&D process.
CDX
Bladder cancer
Kidney cancer
Blood cancer
Liver cancer
Brain cancer
Lung cancer
Breast cancer
Melanoma
Cervix cancer
Head and neck cancers
Choriocarcinoma
Nasopharyngeal carcinoma
Cholangiocarcinoma
Ovarian cancer
Colorectal cancer
Pancreatic cancer
Esophageal cancer
Prostate cancer
Fibrosarcoma
Skin cancer
Gastric cancer
Thyroid cancer
PDX
Colorectal
Esophagus
Gallbladder
Head&Neck
Kidney
Liver
Lung
Ovarian
Pancreas
Sarcoma
Stomach
Case Study: NCI-N87 CDX model in Balb/c nude mice
Result: In the subcutaneously implanted NCI-N87 mouse tumor models treated with DS-8201 and BB1701, the ADCs demonstrated significant inhibitory effects on tumor growth over time.
DMPK Capabilities for ADC
BioDuro's expertise in ADC drug development extends to DMPK. In-vivo services take place in 1,600 ㎡ AAALAC-accredited vivarium facilities, capable of in-vivo studies in 10+ animal species. Comprehensive bioanalyses of ADCs include DAR characterization, in-vitro stability, and plasma concentration-time curve; as well as the processes of absorption, distribution, metabolism, excretion (ADME) and ADA immunogenicity assessment. By integrating ADC-related chemistry and DMPK activities under one roof, we enable customers to rapidly advance their ADC new drug development projects.
ADC in vivo PK profile, in vivo DAR characterization and non-GLP immunogenicity assessment (ADA)
1~20mg ADC satisfies early in vivo mouse PK.
~10 working days for PK analysis；
Bioanalytical range is 50ng/mL ~ 10,000ng/mL;
Reliable PK data with CV% < 15%;
LC-MS/MS methods for free drug monitoring, LLOQ is 0.2 ng/mL.
Case Study: DS-8201 Mouse PK Profile/ Plasma Stability Study
DS-8201a is an antibody-drug conjugate (ADC) approved by the US FDA for a certain population diagnosed with HER2-positive solid tumors. Using only 1 mg of DS-8201a, our DMPK team successfully completed a 28-day in vivo mouse PK study recently. Through meticulous planning, precise sample handling, and the use of highly automated workstations, our team achieved results that were consistent with the literature, demonstrating both efficiency and scientific rigor.
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