🔬 Developed by the University of Virginia, these standards aim to enhance consistency and quality in biologics screening.
📈 The goal is to help companies achieve reliable results across departments, aiding comparison in the industry.
💻 A supportive software package is released for experimental design, applicable to various protein-based products.
Introduction:
Recent advancements in plate-based chromatography experiments have led to the establishment of new guidelines aimed at enhancing the consistency and quality of biologics screening. Developed by researchers from the University of Virginia, these standards seek to address discrepancies in experimental results and improve the overall process development across the industry.
- The University of Virginia team has created guidelines for conducting plate-based chromatography experiments utilizing 96-well plates.
- The primary objective is to enable companies to achieve consistent and repeatable screening results, facilitating comparisons across departments and industry-wide.
- These guidelines aim to address variations in experimental procedures that often result in inconsistent outcomes, as highlighted by the lead researcher, Nick Vecchiarello, PhD.
- The new standards include recommendations on resin binding properties, which are crucial for effective purification processes in biological applications.
- To facilitate the implementation of these guidelines, a supporting software package has been developed, allowing users to design experiments aligned with the new standards and utilize historical data.
Conclusion:
The guidelines and accompanying software package are anticipated to significantly enhance the quality and efficiency of plate-based chromatography in the biologics industry. By standardizing practices and establishing clear parameters for resin performance, these innovations pave the way for improved process development and product purification, ultimately contributing to more reliable outcomes in biopharmaceutical research and development.
