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What we do Biologics Analytical Services

Analytical Services

Supporting Biotherapeutics Development 

Aragen Bioscience provides analytical testing and characterisation services supporting biotherapeutic research, development and manufacturing programmes across multiple stages of the product lifecycle. With expertise across a diverse range of biotherapeutics, state-of-the-art infrastructure, and a commitment to precision, we are your trusted partner in advancing biologics from discovery to commercialization.

We specialize in providing end-to-end analytical solutions for a wide range of biotherapeutic modalities, including: 

  • Monoclonal, bispecific, and multi-specific antibodies 
  • Fusion proteins 
  • Enzymes 
  • Recombinant proteins 
  • Antibody drug conjugates (ADCs)

Our Capabilities

Platform Services for Biologics Developmentimg
Routine Analytical Testingimg
Product Characterizationimg
Bioassay Method Developmentimg
Stability Studies & Forced Degradationimg
Reference Standard Qualificationimg
Method Life Cycle Managementimg

Our Analytical Services

  • Platform Methods 
  • Routine Analytical Testing 
  • Product Characterization
  • Bioassay Method Development
  • Stability Studies & Forced Degradation
  • Reference Standard Qualification (IRS/PRS/SRS)
  • Method Life Cycle Management

Each service is tailored to meet your product’s unique needs and is designed to ensure quality, safety, and compliance throughout the biologic lifecycle.

Why Aragen?

A Partner You Can Trust

  • Breadth of Expertise: Our analytical services cater to both standard and complex biologics, including multi-functional proteins, ensuring precise and reliable results for a wide range of biologic products.
  • Dedicated Facilities: Our facilities support analytical testing and characterisation activities in accordance with applicable quality systems and regulatory requirements.
  • Advanced Analytical Tools: We utilise analytical instrumentation, including LC-MS, CAD, DSF, SPR and DLS, to support biotherapeutic characterisation, analytical testing and development programmes.
  • Qualified and Validated Equipment: All equipment used in our analytical development is qualified and validated in accordance with industry guidelines (GAMP, CSV, etc.), ensuring regulatory compliance and reliable results. 
  • End-to-end Support:  From method development and early-stage research to GMP validation and post-market stability studies, we provide integrated, seamless support throughout the entire product lifecycle.
  • Regulatory Expertise: Our services are aligned with global guidelines such as ICH Q1B, ICH Q2R2, ICH Q5C, ICHQ9R1, ICH Q14 & FDA standards, ensuring that your biologic meets all necessary regulatory requirements for timely approvals.

Aragen supports biologics programmes through analytical, development and manufacturing capabilities across multiple stages of the product lifecycle, including regulatory submission support and commercial manufacturing, where applicable. Contact us today to learn how Aragen’s Analytics Services for Biologics can support the success of your biologics product’s journey from development to commercialization.

Learn more about our end-
to-end capabilities

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