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ADC R&D Service Platform

TOT BIOPHARM provides one-stop ADC R&D sample preparation and druggability study services, facilitating the streamlined progression of R&D from molecular screening to PCC (preclinical candidate compound) molecules. With a successful track record encompassing over all projects and employing various conjugation technologies, DAR value (Drug-to-Antibody Ratio) of the ADC molecules ranging from DAR2-8. Leveraging TOT BIOPHARM's sophisticated and rigorous analytical technology platform, we provide customers with tailored analysis and testing services to ensure the high-quality delivery of ADC molecules.

Service Contents
Contents Service Types
mg-level sample preparation g-level sample preparation
ADC sample preparation scale

– <10 mg

– 10~20 mg

– 20~50 mg

– 50~100 mg

– 100~500 mg

– 500 mg~1 g

– 1~5 g

– 5~10 g

– >10 g

Turnaround Time (TAT)* 1-3 weeks 2-5 weeks
Conjugation method

– Cysteine-based site-specific conjugation

– Enzyme-based site-specific glycoconjugation

– Thiomab-based site-specific conjugation

– ThioBridge-based site-specific conjugation

– Sulfhydryl-based non-specific conjugation

– Amino group based non-specific conjugation

– Other alternative conjugation methods

Large molecular type

– Conventional antibody, bi-specific or multi-specific antibody, nanobody, asymmetric antibody

– Recombinant protein, fusion protein

– Other molecular types

Small molecule type

– Commercially available or patented toxin

– Nucleic acid, polypeptide

– Other molecular types

DAR value preparation range DAR2-8, or other specified DAR value
Analysis

– DAR (RP-HPLC, or HIC-HPLC, or LC-MS)

– Purity (SEC)

– Free drug (RP-HPLC)

– Concentration (UV)

– Endotoxin (optional)

Deliverables

– ADC samples

– Analysis report


*TAT (Turnaround Time):

One Week TAT for the marketed product conjugation types.

Linker MC-GGFG MC-VC-PABC CL2A МС SMCC
Payload Dxd MMAE SN38 MMAF DM1
Conjugation Types Cys conjugation Cys conjugation Cys conjugation Cys conjugation Lys conjugation

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Service Advantages

◇ Experienced

– Over Hundred molecules with different conjugation methods have been successfully delivered

– The entire drug development value chain experience from early R&D to commercialization

– Over 10 Year industry experience of the team leader and core technicians

◇ mg to g level sample preparation

◇ Flexible project customization services, combined with analysis services, to ensure the quality of samples

◇ One-stop ADC service platform

– Seamless transition to subsequent CMC development or integrate into clinical stage development and production, saving costs associated with vendor switches, and achieving one-stop efficient development

Typical Case

Customer Request：Fast delivery of ADC R&D samples in 1 week.

Our Solution
  • Based on the platform method, expand conjugation development and the analysis in quick. After determining the conjugation conditions, proceed with ADC samples preparation.
  • Complete the rapid and efficient delivery of high-quality ADC samples within 1 week. Ensure sample purity >95%, strictly control the required DAR values, and guarantee minimal free drug residues.




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