Increasing understanding of the role of engineering in vaccine development and manufacture: A collaborative project between UCL-Oxford Future Vaccine Manufacturing Research Hub (Vax-Hub) and UK secondary schools

Bioprocess engineering plays a central role in taking vaccines from laboratory development to manufacture for clinical trials and scale up for mass vaccination programs. However, public knowledge and appreciation of this essential role is low, perceptions of vaccine development focusing on scientists in research labs and clinicians administering the vaccine. There is little appreciation of the need for mass-production in factories and the engineering processes involved. This knowledge gap became especially evident during the COVID19 pandemic. The bioprocessing industry is currently in need of qualified personnel, yet students considering their career options are often unaware of these opportunities. In 2022 Vax-Hub, funded by the Department of Health and Social Care via the UK Vaccine network initiated an outreach program to develop a collaborative approach with secondary schools in the London area with aims of: Reducing vaccine hesitancy by joining conversations to address the community’s concerns, increasing our understanding of the reasons behind hesitancy. Increasing awareness of the role of engineering in vaccine development and production – filling the knowledge gap regarding how research is translated from lab studies to commercialisation and clinic. Our programs are tailored to the requirements of the school partner and designed for interaction with school years 9 – 13. Our strategy is to establish interactive long-term partnerships involving: Teacher training in modern vaccine development and manufacture. Workshops in schools introducing biochemical engineering, vaccine manufacture, and career opportunities. Workshops providing practical laboratory skills held at the school and UCL Dept. of Biochemical Engineering. Mini research projects for school groups. During the past year this has resulted in successful development of on-going relationships with two educational institutions. Analysis of feedback from teachers and students indicated that the program is of benefit. Both institutions indicated a positive intention to continue involvement. The program is currently being rolled out further

Male factor infertility and assisted reproductive technologies. indications, minimum access criteria and outcomes

BackgroundInfertility, which is defined as the inability to conceive after at least 12 months of regular unprotected sexual intercourses, affects about 15-20% of couples worldwide and a male factor is involved in about half of the cases. The development of assisted reproductive technology (ART) made it possible to conceive also to individuals affected from severe oligospermia or azoospermia. However, the impact of the male factor on embryo development, implantation, prevalence of chromosomal abnormalities, genetic and epigenetic alterations, and clinical and obstetric outcomes is still controversial.PurposeThis narrative review examines the indications, minimum access criteria, and outcomes by individual ART technique in relation to the male factor

Recombinant human luteinizing hormone co-treatment in ovarian stimulation for assisted reproductive technology in women of advanced reproductive age: a systematic review and meta-analysis of randomized controlled trials

Introduction: Several studies suggest that luteinizing hormone (LH) could improve IVF outcome in women of advanced reproductive age by optimizing androgen production. In this review, we assessed the role of recombinant-human LH (r-hLH) and recombinant human follicle stimulating hormone (r-hFSH) co-treatment in ovarian stimulation for assisted reproductive technology in women of advanced reproductive age candidates for assisted reproduction. Material and methods: Using a preregistered protocol we systematically searched Medline/PubMed, Scopus and the ISI Web of Science databases to identify randomized controlled trials in which r-hFSH monotherapy protocols were compared with r-hFSH/r-hLH co-treatment in women ≥35 years undergoing fresh IVF cycles. We calculated the pooled odds ratio (OR) for dichotomous data and the weight mean difference (WMD) for continuous data with an associated 95% confidence interval (CI). The meta-analyses were conducted using the random-effect model. P values < 0.05 were considered statistically significant. Subgroup analyses of all primary and secondary outcomes were performed only in women aged 35–40 years. Results: Twelve studies were identified. In women aged between 35 and 40 years, r-hFSH/r-hLH co-treatment was associated with higher clinical pregnancy rates (OR 1.45, CI 95% 1.05–2.00, I2 = 0%, P = 0.03) and implantation rates (OR 1.49, CI 95% 1.10–2.01, I2 = 13%, P = 0.01) versus r-hFSH monotherapy. Fewer oocytes were retrieved in r-hFSH/r-hLH-treated patients than in r-hFSH-treated patients both in women aged ≥35 years (WMD -0.82 CI 95% -1.40 to − 0.24, I2 = 88%, P = 0.005) and in those aged between 35 and 40 years (WMD -1.03, CI − 1.89 to − 0.17, I2 = 0%, P = 0.02). The number of metaphase II oocytes, miscarriage rates and live birth rates did not differ between the two groups of women overall or in subgroup analysis. Conclusion: Although more oocytes were retrieved in patients who underwent r-hFSH monotherapy, this meta-analysis suggests that r-hFSH/r-hLH co-treatment improves clinical pregnancy and implantation rates in women between 35 and 40 years of age undergoing ovarian stimulation for assisted reproduction technology. However, more RCTs using narrower age ranges in advanced age women are warranted to corroborate these findings

Oral contraceptives and changes in nutritional requirements

Oral contraceptives (OCs) are a major class of prescription drug, used by a large proportion of women starting from early adolescence. Much research has been conducted to investigate the physiological changes that occur in women who take OCs. These include changes in general health as well as in nutritional needs. In terms of nutrition, several studies investigated whether women on OCs need different amounts of some vitamins and minerals. In particular, a report from the World Health Organization (WHO) points out that the influence of OCs on nutrient requirements is a topic of high clinical relevance and should, therefore, receive great attention. It has been shown that the key nutrient depletions concern folic acid, vitamins B2, B6, B12, vitamin C and E and the minerals magnesium, selenium and zinc. Most research has focused on the levels of these vitamins and minerals in the blood of women who take OCs compared to women who do not. Since women who take OCs not always have adequate diet, may have unhealthy life style or may suffer from pathologies of malabsorption, the possibility to prevent vitamin and mineral deficiencies by taking appropriate dietary supplements should be considered a first-line approach by clinicians

Which key performance indicators are most effective in evaluating and managing an in vitro fertilization laboratory?

The laboratory is the heart of an in vitro fertilization (IVF) clinic, and a quality management system is critical for its administration. We review the main structural, process, and outcome key performance indicators (KPIs) to provide laboratory managers with concrete tools aimed at enhancing the quality of their work. Three concepts must be stressed when dealing with KPIs in IVF: [1] always consider the three types of indicators (structural, process, and outcome related), [2] carefully adapt the control chart to either promptly identify issues and adopt corrective measures, or redefine the control limits in a process called "progress building," [3] consider that achieving a healthy live birth is a multidisciplinary effort that is subject to several confounders, which must be recognized and accounted for in the analyses. In this regard, future KPIs shared among clinicians and embryologists are desirable to enhance the quality of infertility care for IVF patients

Male factor infertility and assisted reproductive technologies: indications, minimum access criteria and outcomes

Background: Infertility, which is defined as the inability to conceive after at least 12 months of regular unprotected sexual intercourses, affects about 15-20% of couples worldwide and a male factor is involved in about half of the cases. The development of assisted reproductive technology (ART) made it possible to conceive also to individuals affected from severe oligospermia or azoospermia. However, the impact of the male factor on embryo development, implantation, prevalence of chromosomal abnormalities, genetic and epigenetic alterations, and clinical and obstetric outcomes is still controversial. Purpose: This narrative review examines the indications, minimum access criteria, and outcomes by individual ART technique in relation to the male factor