ResourceLife Sciences
Cleanrooms, GMPs and ISO Certification
9 Jun 2021In this application note, PHCBi outlines the threats to cell culture-based product production and highlights how laboratories and clinical manufacturers can avoid them through establishing and maintaining a cleanroom that meets Good Manufacturing Practice (GMP) guidelines.
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Cell / Tissue CultureCell culture or tissue culture is used to study the biology of cells or tissues and to isolate cellular products in an environment which can be manipulated and well defined. Accurately control your culture environment with bioreactors or culture incubators, bind your cells to a surface or together with an extracellular matrix. Distinguish cell types with differential media or proliferate cells with certain characteristics using selective media. Enrich your media with supplements such as growth factors, sera and vitamins. Find the best cell and tissue culture products, kits and equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Cell Lines Stem Cells and Primary CellsPrimary cell cultures, established cell lines and stem cells are vital for <i>in vitro</i> and <i>ex vivo</i> experimentation. High-quality cells, optimized for your applications, alongside optimized cell substrates, growth medium and supplements, are critical for experimental success. Explore a range of cells suitable for your applications, including isogenic cell lines, competent cells, induced pluripotent stem cell (iPSC)-derived cell lines, fungal/bacterial/mammalian cell lines, stem cells and cancer cell lines. Find the best cells for your research in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Refrigerators Freezers and CryogenicsRefrigerators, Freezers & Cryogenics can be used for preservation or experimental purposes. Types of freezers include deep freeze, -80C°C, ultra-low temperature, explosion proof, cryogenic and controlled rate freezers. Freezing is also used in freeze-drying equipment for dehydration processes. Feature to consider in freezers include temperature control and recorders, failure alarms and self-closing mechanisms.Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. ULT FreezerSample StoragePreserving clinical trial samples to the highest standards is a critical component in maximizing the value of present day and future clinical research. Specialized storage and transportation of these tissue, blood and serum samples reduces the risk of them being damaged or lost.Cell CultureCell culture involves growing cells under controlled conditions, typically outside of their natural environment, to study cellular behavior, drug response, and disease models. Cell culture is crucial in biotechnology and biomedical research. Explore cell culture products in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.ManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.