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European Biopharmaceutical Review

Streamlining Affinity Analysis for Accelerated Lead Screening, Characterisation, Optimisation, and Final Selection

Drug molecules are increasing in complexity, with bispecific and trispecific antibodies, fusion proteins, and antibody-drug conjugates (ADCs) gaining prominence within drug discovery programmes. Most analytical techniques are unable to measure sequential binding events to evaluate a single molecule’s specificity and affinity to multiple targets in one assay set up. That is an absolute requirement for these types of leads. With increasing complexity in the molecular library, along with an increase in the number of drug development programmes that are run in parallel, higher throughput affinity measurement methods are continuously sought to keep pace with specialised assay requirements for these drug candidates’ characterisation.

There are several challenges associated with generating reliable kinetic and affinity information about early candidates, also known as ‘hits’, at various stages of the lead selection process:

  1. Multiple instruments needed to run large screens all the way to high-quality characterisation rapidly to eliminate unsuitable candidates
  2. The ongoing increase in number and complexity of molecules with distinct assay requirements
  3. Reliably measuring affinity for lead candidates with slow off-rates and/or high affinities
  4. Sample consumption, especially during early stages of screening when sample quantities are low
  5. Need for expert operators

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Sartorius is a leading international partner of life science research and the biopharmaceutical industry. With innovative laboratory instruments and consumables, the Lab Products & Services Division serves the needs of labs performing research and quality control at pharma and biopharma companies and those of academic research institutes. The Bioprocess Solutions Division, focusing on single-use solutions, helps customers to manufacture biotech medications and vaccines safely and efficiently. In 2020, the company earned sales revenue of some €2.34 billion. At the end of 2020, nearly 11,000 people were employed at the Group’s more than 50 manufacturing and sales sites, serving customers worldwide.
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