Grand Challenges in Pharmaceutical Research Series: Ridding the Cold Chain for Biologics.

Biologics are complex pharmaceuticals that include formulated proteins, plasma products, vaccines, cell and gene therapy products, and biological tissues. These products are fragile and typically require cold chain for their delivery and storage. Delivering biologics, while maintaining the cold chain, whether standard (2°C to 8°C) or deepfreeze (as cold as -70°C), requires extensive infrastructure that is expensive to build and maintain. This poses a huge challenge to equitable healthcare delivery, especially during a global pandemic. Even when the infrastructure is in place, breaches of the cold chain are common. Such breaches may damage the product, making therapeutics and vaccines ineffective or even harmful. Rather than strengthening the cold chain through building more infrastructure and imposing more stringent guidelines, we suggest that money and effort are best spent on making the cold chain unnecessary for biologics delivery and storage. To meet this grand challenge in pharmaceutical research, we highlight areas where innovations are needed in the design, formulation and biomanufacturing of biologics, including point-of-care manufacturing and inspection. These technological innovations would rely on fundamental advances in our understanding of biomolecules and cells.

Transforming cold chain performance and management in lower-income countries.

In many countries, one of the common factors limiting full and equitable access to effective immunization is the existence of gaps in cold chain and logistics (CCL) systems. This article focuses on the critical contribution that better management of CCL performance can make in addressing these barriers, as well as some essential practices needed to achieve and sustain these gains. These include (i) an emphasis on continuous improvement in CCL performance indicators, (ii) strong coordination and accountability across multiple stakeholders, and (iii) making the most of limited financial resources. This article is informed by the Clinton Health Access Initiative's (CHAI's) experience working with National Immunization Programs (NIPs) and immunization partners to improve the effectiveness and efficiency of CCL systems (including CCE deployment and maintenance, temperature monitoring and control, stock management and distribution) across ten Gavi-supported "focus" countries.

The origins of the vaccine cold chain and a glimpse of the future.

International efforts to eradicate smallpox in the 1960s and 1970s provided the foundation for efforts to expand immunization programmes, including work to develop immunization supply chains. The need to create a reliable system to keep vaccines cold during the lengthy journey from the manufacturer to the point of use, even in remote areas, was a crucial concern during the early days of the Expanded Programme on Immunization. The vaccine cold chain was deliberately separated from other medical distribution systems to assure timely access to and control of vaccines and injection materials. The story of the early development of the vaccine cold chain shows how a number of challenges were overcome with technological and human resource solutions. For example, the lack of methods to monitor exposure of vaccines to heat during transport and storage led to many innovations, including temperature-sensitive vaccine vial monitors and better methods to record and communicate temperatures in vaccine stores. The need for appropriate equipment to store and transport vaccines in tropical developing countries led to innovations in refrigeration equipment as well as the introduction and widespread adoption of novel high performance vaccine cold-boxes and carriers. New technologies also helped to make injection safer. Underlying this work on technologies and equipment was a major effort to develop the human resources required to manage and implement the immunization supply chain. This included creating foundational policies and a management infrastructure; providing training for managers, health workers, technicians, and others. The vaccine cold chain has contributed to one of the world's public health success stories and provides three priority lessons for future: the vaccine supply chain needs to be integrated with other public health supplies, re-designed for efficiency and effectiveness and work is needed in the longer term to eliminate the need for refrigeration in the supply chain.

Línea fría: “caso Hospital Sant Pau” / Cold line: I marry Hospital Sant Pau

El sector de la restauración colectiva ha evidenciado en los últimos años diversos retos: hacer frente a los cambios normativos en materia de seguridad alimentaria, adaptarse a las nuevas disposiciones y requisitos europeos en el ámbito de la nutrición hospitalaria y todo ello bajo las necesidades constantes de mejorar la eficiencia ajustándose a un mercado competitivo marcado por dificultades operacionales (AU)

The sector of the collective restoration has demonstrated in the last diverse years challenges: to face to the normative changes as for food safety, to adapt to the new dispositions and European requirements in the area of the hospitable nutrition and all this under the constant needs to improve the efficiency adjusting to a competitive market marked by operational difficulties (AU)