Automation of Analytical Procedures

For quality control (QC) of biopharmaceuticals, cell-based assays (CBA) and/or binding assays are essential for batch release and stability assessment for both drug products and drug substances. A typical CBA exhibits an intrinsic variability influenced by factors such as the number of pipetting steps, assay complexity, analyst experience, and the use of living cells, unlike ELISA or SPR binding assays. Although end-to-end assay automation has been increasingly adopted in recent years in the industry, it remains a significant challenge, particularly for QC release assays in a GMP environment. Microplate-based bioassays involve numerous sequential and various manual pipetting steps that can be broken down into distinct sequences, allowing selective automation of specific parts of the assay.

Poster: Semi-automated potency assay with increased consistency and less hands-on time (case study)

By implementing a modular automation approach for testing, the limitations of full automation - such as inflexibility and high initial costs - can be overcome, providing a more adaptable and cost-effective solution. For semi-automation, tools such as the handheld 96-channel electronic pipettes (e.g., Integra VIAFLO96), small pipetting robots (e.g., Integra ASSIST PLUS), or liquid handler (e.g., Hamilton MICROLAB STAR) can streamline routine pipetting tasks but can also be employed in method development. These tools not only enhance assay consistency and automate repetitive processes but also significantly reduce analyst time and effort.

At Eurofins BioPharma Product Testing, we are applying semi-automation during method development, validation, and transfer for different method parts such as:

• Aspiration and Dispensing of liquids, antigens, or antibodies
• Washing steps required for Flow Cytometry or ELISA methods
• Cell seeding
• Predilution, serial dilutions and transfer steps
• Complete or partial method performance using Liquid Handler

Our team of scientists has extensive experience in implementing semi-automation across various methods. We use state-of-the-art equipment to ensure accurate and reliable testing results, customizing our services to meet the unique needs of each project, product, and method. We provide personalized solutions and support throughout the entire process.

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