There is huge pressure on biomanufacturing facilities due to high demand for gene therapy products such as recombinant adeno-associated viral (AAV) vectors made under current good manufacturing practice (GMP) conditions. The constraints of the scale-up process are rarely taken into consideration during clinical process development, with many facilities simply scaling-out adherent cell stack protocols, procedures, and test methods. In order to demonstrate the importance of cost economics linked to the choice of scale-up processes, this study provides a detailed cost modeling analysis comparing viral vector production in adherent cells in cell stacks to viral vectors produced in bioreactors, either in suspension using a stirred bioreactor or adherently in fixed-bed bioreactor. The results show that single-use bioreactors allow the cost of installed capital and labor to be reduced significantly and that fixed-bed bioreactors with optimized production protocols offer the greatest experimental robustness and the best opportunity for increased productivity in a manufacturing facility.
Adjacency testing for delay faults is examined in both theory and implementation. We shall show that the necessary and sufficient conditions for adjacency testability yield an efficient methodofrobust delay test generation. Empirical results (including several different cost measurements) are presented which demonstrate that our technique: (1) achieves high fault coverages under both the robust and nonrobust delay fault models and (2) is cost effective.in our method is the generation of the stuck-at test which we modify to obtain a vector pair. We shall show that the ratio of detected delay faults to the number of stuck-at vectors is high. Consequently, DATG is straightforward and efficient. Moreover, many 'other techniques do not consider the Possibility of test invalidation due to hazards and multiple faults. We will present empirical results which demonstrate that our test sets have a high robust &lay fault coverage (i.e., our delay tests are valid even in the presence of multiple delay faults and/or hazards). Hereafter our delay tests will be referred to as DATs (Deterministic Adjacency
This paper provides an application oriented discussion on the design for test techniques utilized on the MC68340 Integrated Processor Unit. The principal topics covered are: the MC68340 test methodology, structured design techniques, and the use of CAD tools for automatic test pattern generation.
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