Seed production quality standards

The seed stock principle for the preparation and quality control of MCBs and WCBs is an essential part of cell banking procedures, regardless of the intended use for the cells. The size of each bank and the level of quality control used are generally dependent on individual requirements and facilities. However, where a cell line or its products is to be involved in procedures under the jurisdiction of regulatory authorities, the cell banking procedures, characterization and quality control must address specific requirements for procedures and documentation. Finally, the intended use of cells or their product must determine the level of quality assurance required, and the person responsible for exploitation of the cells or product must identify the appropriate quality standard and select an agency accredited to that standard. 

Low Resolution Nuclear Magnetic Resonance (LR-NMR) systems are routinely used for food quality assurance in laboratory settings [25]. NMR based techniques are standardized and approved by the American Oil Chemist s Society (AOCS) (AOCSd 16b-93, AOCS AK 4-95), the International Union of Pure and Applied Chemistry (IUPAC) (solid fat content, IUPAC Norm 2.150) and the International Standards Organization (ISO) (oil seeds, ISO Dis/10565, ISO CD 10632). In addition to these standardized tests, low resolution NMR is used to measure moisture content, oil content and the state (solid or liquid) of fats in food. Table 4.7.1 summarizes common food products that are analyzed by low-resolution NMR for component concentration. 

Since the lack of information on product chemistry and quality can affect its market access and limit prices received in cormtry of origin, we propose the initial and selected standards for Griffonia seeds as presented in Table 111, to strengthen the relatiorrship between the eolleetors, proeessors and exporters and to provide clartiy and produet definition to the international buyers and users. 

Media for the production phase are usually richer in nutrient content than the seed train medium in order to maintain viability and productivity of the cells for a minimum of 1-2 weeks. For facilitating recovery and purification of the product and for cost reduction, serum is not used for the production phase. The attachment of cells to the surface of the rollerbottle wiU not be compromised by such a modification in the medium. However, gentle handling is required or the sheets of cells will detach. Upon incubation of the confluent cells with the enriched, serum-free medium, the secreted product will be harvested, leaving the adherent cells inside the bottle. Sometimes, a refeeding with fresh medium for a second production cycle is possible, on the condition that the product of the first and the second harvest will be similar in composition and quality. Since a standard 2-L rollerbottle will contain about 300 mb of medium for harvest, 1000 roUer-bottles will provide from 300 L to 600 L of supernatant. Over a one-year period, a manufacturing process based on this schedule will deliver 15 000-30000 L of... 

The British Standards Institution Publicly Available Specification (PAS) 100 [8] covers the range of materials used to make the compost, their quahty arrd traceability, the minimttm requirements for the process of composting and the quality of the end product The PAS 100 specification is a minimum specification and limits stones, weed seeds and pl sical and chentical contaminants. 

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