{"id":4703,"date":"2019-06-28T14:54:38","date_gmt":"2019-06-28T14:54:38","guid":{"rendered":"https:\/\/www.thermofisher.com\/blog\/analyteguru\/quality-by-design-understanding-how-to-develop-and-make-better\/"},"modified":"2024-02-15T23:17:26","modified_gmt":"2024-02-15T23:17:26","slug":"quality-by-design-understanding-how-to-develop-and-make-better","status":"publish","type":"post","link":"https:\/\/www.thermofisher.com\/blog\/analyteguru\/quality-by-design-understanding-how-to-develop-and-make-better\/","title":{"rendered":"Quality by Design: Understanding How to Develop and Make Better Biologics"},"content":{"rendered":"
\"\"I’m a planner by nature and as a full-time working mum I run a tight ship. You could say I try to implement the principles of Quality by Design1<\/sup> (QbD) at home. Utilizing multiple lists, schedule planners and detailed weekly menu options (with accompanying recipes and corresponding shopping lists… I wish I was joking), I try to navigate the weekly work\/life juggles and daily toddler dramas.The principles underpinning QbD are by no means new and many industries have benefited from the concept to improve their product and process quality. Regulatory agencies such as the U.S Food and Drug Administration<\/a> (FDA) and the European Medicines Agency<\/a> (EMA) have adopted the principles to enhance the discovery, development, and manufacture of therapeutic drugs.<\/p>\n

With regards to pharmaceutical or biopharmaceutical QbD, the approach specifically aims to ensure the quality of therapeutics by employing analytical, statistical and risk management methodologies in their design, development and manufacture and quality control. To ensure both drug efficacy and safety, a key goal of QbD is to ensure that all process-related sources of variability are identified, understood and managed.<\/p>\n

QbD guidelines require a comprehensive understanding and thorough characterization of a drug’s critical quality attributes (CQAs) at the molecular level, which relies heavily on analytical technologies such as high performance liquid chromatography and mass spectrometry as well as many other characterization technologies. CQAs are identified and used to inform product quality, safety and efficacy throughout development and manufacturing and ultimately to ensure the desired product quality is met prior to lot-release.<\/p>\n

Traditionally, multiple assays are used in combination to identify and monitor CQAs individually, whilst many are profile-based and are often not capable of identifying and quantifying potential amino acid residue-specific CQAs.<\/p>\n

The Thermo Scientific\u2122 HR Multi-Attribute Method (MAM)<\/a> is a powerful high resolution accurate mass (HRAM)-based workflow that has been designed to simplify and standardize biopharmaceutical characterization and quality control. This HRAM-based analytical workflow can replace many of the time-consuming methods typically required for the characterization and QC of therapeutic proteins and enables identification, quantitation, and monitoring of multiple CQAs simultaneously in a verified workflow, serviced and supported by MAM experts from a single laboratory partner.<\/p>\n

Other HR MAM benefits include:<\/p>\n