Increasing capacity utilization and lowering manufacturing costs are critical for pharmaceutical companies to improve their competitiveness in a challenging environment. Development of next generation cell lines, improved media formulations, application of mature technologies and innovative operational strategies have been deployed to improve yields and capacity utilization. This article describes a large-scale perfusion strategy for the N-1 seed train bioreactor that was successfully applied to achieve higher inoculation cell densities in the production culture. The N-1 perfusion at 3,000-L scale, utilizing a inclined settler, achieved cell densities of up to 158 × 10(5) cell mL(-1) at perfusion rates of 2950 L day(-1) and a retention efficiency of >85%. This approach increased inoculation cell densities and decreased cultivation times by ~20% in a CHO-based, fed-batch antibody manufacturing process while providing comparable culture performance, productivity, and product quality. The strategy therefore yielded significant increase in capacity utilization and concomitant cost improvement in a large scale cGMP facility. Details of the strategy, the cell retention device, and the cell culture performance are described in this article.

No abstract

South Africa has opened up access to higher education over the past 20 years. The massive increase in enrolments (with almost 70% first-generation students) substantially affects progress and graduation rates in Science programmes in higher education. First-year students in Science realise that university mathematics requires knowledge and skills that are not part of their academic repertoires. Science students at the University of Johannesburg register for a two-week, credit-bearing First-year Seminar (FYS). The research question that this paper addresses is: What is the relationship between the Firstyear Seminar and the mathematics performance of first-year students in Science? The specific purpose is to determine the relationship between: (1) students' school mathematics background; (2) the problemsolving skills sessions of the FYS; and (3) their first-year performance in mathematics. It was found that the FYS enhances students' ability to make a successful transition to university, with problemsolving ability acting as a fair predictor of performance in first-year mathematics. The empirical data was collected through a before-and-after test performed by the 2014 cohort with regards to students' attendance of the FYS. Notably, the data indicate that the value added by the problem-solving test can be applied to identify and engage students who have high probability of becoming students at risk (STARs).

Parentage law is heavily influenced by the number “two.” The traditional paradigm of one mother and one father, especially a married mother and father, has been a bedrock of Western society. In recent decades, however, the traditional two parent paradigm has started to erode and courts have responded. For example, some courts have held that a child can have two legal parents of the same sex. In other cases, a child has been deemed to have just one legal parent and yet in others, even three legal parents. These cases highlight shifts within the law of parentage that have occurred as the nuclear family has decreased in prominence and as the use of assisted reproductive technologies has changed the ways in which families are created. I have previously advocated for the expansion of legal parentage to persons not traditionally considered a legal parent, such as the lesbian partner of a legal mother. I have also suggested that, in limited circumstances, courts consider conferring legal parentage in more than two adults who are raising a child including recognizing that a child might have two fathers. In my home state of Michigan, the traditional two parent paradigm is firmly entrenched as illustrated, in part, by the state's strict marital presumption, which does not permit a putative father the ability to challenge the husband's paternity. About one‐fifth of U.S. jurisdictions have a similarly strict marital presumption. In this short essay, I criticize the lingering marital presumption and use the critique to illustrate broader inconsistencies within the law of parentage. I also make some modest suggestions for parentage law reform. Key Points for the Family Law Community: Family law should embrace changing family forms and recognize more than two legal parents for some children. The marital presumption, while historically expedient, should be replaced with an intent and function based assumption of parentage.

No abstract