Payloads & Linkers-Asymchem Labs.

Toxin Linker

Asymchem Pharmaceuticals' Payload Linker (toxin linker) team serves the R&D and manufacturing of ADC drugs worldwide. With over ten years of process development experience in toxin linker production, and leveraging the group's outstanding small molecule R&D and manufacturing capabilities, we can rapidly help customers address technical challenges in R&D and manufacturing, and accelerate products to market.

We provide one stop CMC services for Payload Linker covering the IND, NDA and commercial production stages. The toxin linker R&D center is equipped with 1,500m² of specialized R&D laboratories, and staffed by experienced process R&D, analytical, purification and manufacturing technical personnel. We have R&D, manufacturing and regulatory submission experience across more than 60 IND projects and more than 10 NDA projects.

Service Platform

Liquid phase and solid phase synthesis experience, extensive purification experience, comprehensive analytical methods, rigorous impurity control, and in stock key intermediate reserves

Attachment

Click Chemistry category

Maleimide category

Others

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Linker

Peptide category

PEG category

Sugar category

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Payload

Auristatin category

Maytansine category

Tubulysin

...

Capacity Expansion

Passed official FDA high potency audits in 2014 and 2019, with end to end production lines for OEB 5 compounds and excellent dust control capability (OEL ≤ 1 ng/m³)

The HP workshop is equipped with 300L to 1,000L reactors of various sizes, high performance preparative purification equipment of different scales such as DAC150 to DAC450, and 1m² to 10m² lyophilization equipment.

Over 8,000m² GMP HP production area, Class D and Class C zones (isolators)

It is capable of conducting more than 30 CMC projects in parallel.

Quality & Analytical Capabilities

Analytical method development, optimization and validation.

Cleaning method development and validation

Stability studies (using MiniTab for stability trend analysis, HRMS (Q Exactive/Q Tof) identification of hydrolytic impurities, LIMS sample management, Vaisala temperature and humidity monitoring system)

Qualification and re qualification of reference standards and impurity reference standards

Release testing covering the full manufacturing workflow (RSM, intermediates and APIs)

Comprehensive analytical platform (UV, IR, SEC, UPLC, HPLC, LC MS/MS, NMR, CD, IC, ICP/MS, GC/HS GC, KF)

High resolution mass spectrometry platform (QTOF, Orbitrap Fusion Lumos Tribrid)

Purification Capabilities

Purification methods

RPC, NPC, HILIC, HIC, IEC

Mobile phase

Acid, Alkali, Buffer, Ion Pair Reagent, Salt

Chromatographic stationary phases

C18, C8, C4, Polymer, Phenyl Silica

Cyanide, Diol, Amino, Methylimidazole

WAX, WCX, SAX, SCX

Waters R&D Prep-HPLC

YMC Prep-HPLC with DAC-600

YMC Prep-HPLC with DAC-100

DAC150/DAC200/DAC300/DAC450

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