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Equipment selection doesn’t end at the cleanroom door. Selecting appropriate equipment for advanced cell and gene therapeutics based on cGMP compatibility extends beyond the traditional production environment and into supporting processes like R&D and quality control. Equipment in these labs needs to meet the highest standards for performance and qualification, whilst being flexible enough to meet the demands of protocol modifications.
In advanced therapeutics, QA/QC involves a comprehensive set of processes and procedures to verify that products meet defined quality standards and regulatory requirements. It encompasses various aspects including raw material testing, in-process testing, and final product testing, to ensure that all stages of manufacturing and production adhere to quality specifications. During this testing, basic accessory equipment like incubators, environmental chambers, orbital shakers, etc., play a crucial role in the QA/QC process by providing controlled and stable conditions for testing and monitoring various parameters. This monitoring can identify of potential issues, such as microbial contamination, product degradation, or packaging failures, ensuring that products meet the required quality standards before reaching the market.
By utilizing robust cGMP compatible equipment, organizations can replicate real-world conditions and evaluate product performance accurately. Keeping the cGMP compatibility of equipment in mind during selection protects the long-term integrity of the QA/QC laboratory throughout the development and production process.