Products and Services - Amaran Biotech - Your Total CDMO Solution

Amaran Biotech provides a range of drug development services, from initial process development & optimization, supply chain management, to clinical and commercial cGMP-compliant manufacturing with a comprehensive range of analytical and regulatory support.

AB-801 Adjuvant (QS-21)

Enhancing Vaccine Efficacy Through Innovation

Adjuvants, in combination with vaccines, are receiving more attention than ever due to their broad usage during the COVID-19 pandemic. Amaran Biotech manufactures and sells a high-grade adjuvant product, code named AB-801, that has similar application capabilities as the widely used QS-21 adjuvant.

Key Benefits

Enhances immune response in vaccine recipients
Reduces required antigen dosage
Derived from natural source (Quillaja saponaria)
Comparable efficacy to QS-21

Asia-Pacific Biopharma Excellence Awards 2025

Drug Product Manufacturing

Leading Robotic Aseptic-Filling System

Amaran Biotech is proud to offer the very first leading edge robotic aseptic-filling system in Taiwan. The filling line features an integrated gloveless robotic isolator that eliminates operator intervention and utilizes advanced automation to seamlessly combine every aspect of the aseptic process.

Key Features

Robotic Technology/Gloveless Isolator
Nested Material Handling
Rapid VPHP (Vapor Phase Hydrogen Peroxide) decontamination
Suitable for vaccine and early phases of clinical IMP production
All-in-one isolator solution with filling
Full compliance with data integrity

Taiwan Biopharma Excellence Award 2025

Drug Substance Manufacturing

Proven Expertise in Complex Drug Manufacturing

Amaran Biotech's teams have the technical expertise and knowledge of the necessary standards to execute the manufacturing of complex, high-value drug substances. We have a solid track record of successful delivery of a full spectrum of products with a special focus in the realm of immunotherapy.

Custom Manufacturing

Ozonolysis
Column Purification (Pre-HPLC, MPLC, FPLC)
Lyophilization
Protein and Natural Product Purification
Carbohydrate Synthesis
Process Scale-up and Process Validation

Global Standards, Uncompromised Quality

Our modern state-of-the-art manufacturing facility features a PIC/S quality system in compliance with global pharmaceutical guidelines such as ICH, USP, and EP. Our facilities are also fully compliant with major regulatory requirements including US FDA, TFDA, and EMA.

Stability Study & Analytical Services

Complete Solutions for Your Analytical Needs

Our scientific team provides best-in-class services in method development, method validation, and sample testing to meet current USP/EP requirements. Our extensive experience and up-to-date regulatory knowledge allow us to consistently meet our clients' needs.

Stability Study Services

We support clients with stability storage and testing services to meet ICH requirements at every phase of drug development, offering five storage conditions:

-80°C
-20°C ± 5°C
5±3°C
25°C RH 60%
40°C RH 75%

Chemical Laboratory

Protein characterization：

RP-HPLC/size exclusion-HPLC
AEX-HPLC
ELISA Reader
UVP BioSpectrum
UV Spectrophotometer
SDS-PAGE/Western Blot/Silver Stain/Dot Blot

Others：

DLS (Dynamic Light Scattering)
FTIR
Karl Fischer
HPAEC-PAD
GC/Head Space/FID/TCD
(Milliflex PLUS): Liquid sample microbiology test by Membrane Filtration
Analytical method development and validation
Material Test Machine

Microbiology Laboratory

Sterility performed in SKAN isolator
Development and Qualification of Microbial Testing Method
Liquid Particle Counter
Bioburden
Endotoxin

Environment Monitoring Programs

Particle counter
Settle plate
Air Sampler
Water System

Sourcing & Consultation Services

Comprehensive Sourcing & Strategic Consultation Services

Supply Chain Services

Critical Material Sourcing
Vendor Sourcing and Evaluation

Quality Assurance Services

Current cGMP consulting
Quality system set up and improvement
Vendor audits

Regulatory Affairs Services

CTD Module 3 preparation consulting
Regulatory authority submission strategy consulting