HPAPI

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Anthem has the capability to handle toxicity levels up to OEB 5, our infrastructure and expertise enable the synthesis of highly potent compounds for innovative targeted therapies.

End-to-End Solutions for HP APIs

Robust and scalable processes for synthesis

Stringent quality control and optimized process parameters

Safe handling practices and state-of-the-art containment solutions

Expertise in High-Potent Linkers and Toxins

Linkers

Anthem designs and synthesizes innovative linkers tailored to cleavable chemical moieties, our diverse portfolio includes:

Hydrazones | Peptides | Disulphides | Pegylated Linkers | Thioethers | Carbohydrates

We handle multi-gram scale production of potent toxins, including:

Auristatins | Dolastatins | Maytansines | Calicheamicins | Duocarymycins | PBD Dimers | α-Amanitin

Ensuring complete containment during handling, our capabilities include:

  • Batch production of up to 10 kg with scalability for multi-batch runs.
  • High-quality conjugates tailored for targeted therapeutic applications.

Containment

17 isolators dedicated to high-potent operations, qualified for OEB 5 with an OEL of 1 µg/m³

Reactors

Precision reactions in all-glass jacketed reactors (5L, 10L, and 20L)

Purification

Advanced purification technologies like Column Chromatography and Vacuum Tray Drying

Lyophilization

A 30 kg capacity lyo facility for controlled drying processes

Anthem’s cGMP Containment Facilities

Global Standards Compliance

Our processes and facilities meet global pharmacopoeia standards, including:

  • USP/NF | EP | BP | JP | ACS | AOAC
  • We integrate client-provided methods, ensuring bespoke solutions that meet specific regulatory requirements

Certifications and Safety Standards

  • 21 CFR Part 11 Compliance | CAIH Certified | ISPE-Validated Isolators