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Bioassays

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Bioassays represent an essential step for the development of new drugs. According to regulatory requirements, they are performed to determine the biological activity or potency of a product, a critical quality attribute as explained in ICH Q6B.

Due to their complex nature, bioassays are one of the most challenging tests to perform. Indeed, to perform and to develop consistent assays it is necessary to have a controlled environment, skilled analysts with a thorough understanding of cell physiology and a well developed and characterized method; furthermore, compared to animal assays are less time consuming, less costly and less variable.

• Bioassays are used for determination of biological activity (potency) of biopharmaceuticals, that include all substances which are manufactured using bacteria or cells (biotechnology)
• Required as Quality Control (QC) test for all biologics
• Potency bioassay can be used as GMP QC test
• Validation of Bioassay is required for clinical phase III samples

Moreover, the possibility to build specific clients ad hoc bioassays is one of the most challenging issues in the creation and testing of new drugs product.

 

Our development, optimization, validation and performance of bioassays/potency assays are US FDA approved and are conducted according to GMP regulations. Validation strategies are based on sponsors requirements as well as international guidelines and recommendations (e.g. ICH, US-FDA, ISO, EMEA).

Our services include development and optimization of tailor-made bioassays, validation of tailor-made bioassays according to international guidelines and recommendations (e.g. ICH, US-FDA, ISO, EMEA), Quality Control, Batch release testing and stability testing according to GMP regulations.

We provide a dedicated service for all your bioassay needs and we can can support you within all phases of your assay development/validation. Dedicated analysts/scientists can be assigned for any specific sponsor training request. We can also adopt the Full Time Equivalent (FTE) team approach upon client’s request and allocate a specific Project Manager that will follow the entire project’s flow.

Bioassay service design
  • Assay development, validation and method transfer according to international guidelines and recommendations (e.g. ICH, USP/EP, US-FDA, ISO, EMA)
  • Set-up, development and optimization of tailor made bioassays
  • GMP batch release and stability testing
  • Qualification of critical reagents
Bioassays & Ligand-bind assays
  • Cell based potency assays (eg. ADCC, ADPC, CDC)
  • Binding assays (ELISA, competitive ELISA, Alpha-screen)
  • Bioprocess residual assays
  • Coagulometer assays
Our experience on products
  • Monoclonal Therapeutic Antibodies
  • Bispecific Monoclonal Antibodies
  • Antibody Drug Conjugates (ADC)
  • Complex Antibody like constructs
  • Proteins/Peptides
  • Vaccines
  • Raw material

 

Our approach:

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