Accelerated CMC workflows to enable speed to clinic in the COVID-19 era: A multi-company view from the biopharmaceutical industry.

The COVID-19 pandemic has placed unprecedented pressure on biopharmaceutical companies to develop efficacious preventative and therapeutic treatments, which is unlikely to abate in the coming years. The importance of fast progress to clinical evaluation for treatments, which tackle unmet medical needs puts strain on traditional product development timelines, which can take years from start to finish. Although previous work has been successful in reducing phase 1 timelines for recombinant antibodies, through utilization of the latest technological advances and acceptance of greater business risk or costs, substantially faster development is likely achievable without increased risk to patients during initial clinical evaluation. To optimize lessons learned from the pandemic and maximize multi-stakeholder (i.e., patients, clinicians, companies, regulatory agencies) benefit, we conducted an industry wide benchmarking survey in September/October 2021. The aims of this survey were to: (i) benchmark current technical practices of key process and product development activities related to manufacturing of therapeutic proteins, (ii) understand the impact of changes implemented in COVID-19 accelerated Ab programs, and whether any such changes can be retained as part of sustainable long-term business practices and (iii) understand whether any accelerative action(s) taken have (negatively) impacted the wider development process. This article provides an in-depth analysis of this data, ultimately highlighting an industry perspective of how biopharmaceutical companies can sustainably adopt new approaches to therapeutic protein development and production.

Role of nursing associates in addressing the needs of people with dementia in hospital.

It is estimated that people with dementia comprise about one quarter of all inpatients in acute hospital wards, although this could be an underestimate. Healthcare assistants often lack the training and skills, and nurses often lack the time, to provide optimal care for these patients. As a result, the needs of hospital inpatients with dementia are often unmet, they may have suboptimal outcomes compared with inpatients who do not have dementia, and they may experience significantly reduced well-being and quality of life. Nursing associates have a hands-on role in patient care, and their training should equip them with the skills required to overcome communication barriers and identify patients' needs. This article explores the potential role of nursing associates in addressing the needs of inpatients with dementia.

Implementation of Plate Imaging for Demonstration of Monoclonality in Biologics Manufacturing Development.

Monoclonality of mammalian cell lines used for production of biologics is a regulatory expectation and one of the attributes assessed as part of a larger process to ensure consistent quality of the biologic. Historically, monoclonality has been demonstrated through statistics generated from limiting dilution cloning or through verified flow cytometry methods. A variety of new technologies are now on the market with the potential to offer more efficient and robust approaches to generating and documenting a clonal cell line.Here we present an industry perspective on approaches for the application of imaging and integration of that information into a regulatory submission to support a monoclonality claim. These approaches represent the views of a consortium of companies within the BioPhorum Development Group and include case studies utilising imaging technology that apply scientifically sound approaches and efforts in demonstrating monoclonality. By highlighting both the utility of these alternative approaches and the advantages they bring over the traditional methods, as well as their adoption by industry leaders, we hope to encourage acceptance of their use within the biologics cell line development space and provide guidance for regulatory submission using these alternative approaches.LAY ABSTRACT: In the manufacture of biologics produced in mammalian cells, one recommendation by regulatory agencies to help ensure product consistency, safety, and efficacy is to produce the material from a monoclonal cell line derived from a single, progenitor cell. The process by which monoclonality is assured can be supplemented with single-well plate images of the progenitor cell. Here we highlight the utility of that imaging technology, describe approaches to verify the validity of those images, and discuss how to analyze that information to support a biologic filing application. This approach serves as an industry perspective to increased regulatory interest within the scope of monoclonality for mammalian cell culture-derived biologics.

How should we grow cities to minimize their biodiversity impacts?

Urbanization causes severe environmental degradation and continues to increase in scale and intensity around the world, but little is known about how we should design cities to minimize their ecological impact. With a sprawling style of urban development, low intensity impact is spread across a wide area, and with a compact form of development intense impact is concentrated over a small area; it remains unclear which of these development styles has a lower overall ecological impact. Here, we compare the consequences of compact and sprawling urban growth patterns on bird distributions across the city of Brisbane, Australia. We predicted the impact on bird populations of adding 84,642 houses to the city in either a compact or sprawling design using statistical models of bird distributions. We show that urban growth of any type reduces bird distributions overall, but compact development substantially slows these reductions at the city scale. Urban-sensitive species particularly benefited from compact development at the city scale because large green spaces were left intact, whereas the distributions of nonnative species expanded as a result of sprawling development. As well as minimizing ecological disruption, compact urban development maintains human access to public green spaces. However, backyards are smaller, which impacts opportunities for people to experience nature close to home. Our results suggest that cities built to minimize per capita ecological impact are characterized by high residential density, with large interstitial green spaces and small backyards, and that there are important trade-offs between maintaining city-wide species diversity and people's access to biodiversity in their own backyard.

Comparing military and civilian critical thinking and information processes in operational risk management: what are the lessons?

Business continuity has expanded into a discipline that spans most functional areas of large enterprises. Both the military and financial sectors have consistently demonstrated an aptitude to expand the boundaries of continuity planning and crisis mitigation. A comparison of both enterprises is provided to see how their respective methodologies compare. Interestingly, the similarities far outweigh the differences. The paper provides commentary related to comparative insight from risk practitioners' perspectives from within the US Army, one of the largest military organisations in the world, and the Bank of Montreal, one of Canada's leading financial institutions.