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QUALITY & ANALYTICAL SERVICES

Release Testing & Stability Studies

Do you want to release your drug substance or drug product or perform additional stability studies to support your clinical development and market approval?

Whether you wish to transfer your test methods or need to develop them from scratch, we can carry out the necessary release testing and subsequent stability studies, supported by a strong scientific quality control team and an in-house Qualified Person.

 

IN A NUTSHELL

Profit from our long-term experience in traditional antibodies and new biologic formats. Our dedicated team, with in-depth analytical capabilities and regulatory expertise, provides client-focused project management for efficient and effective collaboration to deliver tailored solutions to meet your specific needs. We offer a risk-based quality control approach aimed at achieving your success. Beyond release testing, our services will help you gain in depth knowledge of degradation pathways, assess and confirm the stability of your product, and conduct additional analytical programs to facilitate your market approval.

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OUR CAPABILITIES

Broad Analytical QC Services in a Fully GMP Environment

Stand-alone QC Services - A Selection

Procedure for Stability Studies

Selection of Biopharmaceutical Stability Indicating Methods

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Broad Analytical Spectrum and Extensive Experience 
  • Ample experience in method development, validation, and transfer 
  • Wide selection of robust platform methods 
  • New format expertise for complex biologics
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Reliable and Efficient Release Testing

 

  • Services that are fully compliant for drug substance and product release
  • End-to-end support, ranging from compendial testing to advanced analytics 
  • Efficient process that ensure timely results and speed up your approval timeline
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Insightful and Thorough Stability Studies
 
  • Comprehensive stability studies to assess shelf life and ensure product quality
  •  Stress and forced degradation studies, which reveal critical insights into product stability under various conditions
  • Stability study data to facilitate your clinical development and market approval process

Elevate Your Candidate With The Right CDMO

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