Objectives The aim of this paper is to systematically review available literature to show the specifics in the storage and transport of temperature-sensitive biopharmaceuticals. The work provides a systematic overview of the guidelines associated with ensuring the required temperature conditions during medicinal products storage and transportation until the moment of its administration. It is described a systematic approach to handle temperature excursion that could be observed during storage and transportation, which may have potential impact on medicinal product quality. There are systematically described stability studies needed for effective temperature excursion management that may occur in the biological medicinal products supply chain. Other external factors that may have a negative impact on the quality of biological medicinal products in the supply chain and administration are also considered. The paper describes the technical requirements of equipment, storage areas, transport systems and temperature mapping conditions. Materials and Methods Research of this work is theoretical and includes a detailed review of available literature about storage and transportation of temperature-sensitive biopharmaceuticals. Literature search was done by topic and subject of research, authors and journals, from general to specialized articles and guidelines relevant to the issues of this paper. The targeted search was carried out via the on-line databases such as ScienceDirect, PubMed, medicinal products database of the Agency for Medicinal Products and Medical Devices of Croatia. The regulatory guidelines have been detailed searched through the European Medicines Agency database, International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and World Health Organisation. Results Proper storage and transport of medicinal products with the aim of preserving their quality, efficiency and safety are necessary throughout the entire distribution chain - from drug manufacturers, through wholesale, public or hospital pharmacies, and to the end user - the patient. In the past two decades, biological medicinal products have become the fastest growing class of therapeutics because of their beneficial impact in the treatment of severe and life-threatening conditions and diseases. The global market for biological medicinal products is steadily increasing, and growth is expected in the next couple years due to the increase in approval of biological biological medicinal products as well as growing incidence of chronic conditions among the aging population. As the structure of the biological molecule is very complex it is usually temperature-sensitive and in most cases requires cold chain storage and transportation. The manufacturer is responsible to deliver the medicine to the patient in accordance with the marketing authorization. Storage and transport conditions must be defined and appropriately set not to affect the medicinal product quality and must be based on the stability studies results. Progress and development of biologics has significantly increased the knowledge and understanding influence of stress factors on the stability of protein molecules. All this resulted in the implementation of very good controls over the critical stability parameters during the production and distribution of biological drugs. Of course, additional efforts are needed to improve the last step in the drug supply chain, the step before medicinal product being administered by the healthcare professional or the patient itself. There is a clear need to perform and publish more research to better understand the extent of the severity of the risk associated with post manufacturing handling of protein pharmaceuticals (for various classes as well as specific examples of protein drugs, e.g., monoclonal antibodies in general vs. a specific monoclonal antibody drug product). Studies should ideally address 2 questions: (1) does postproduction (mis)handling of protein pharmaceuticals cause protein degradation and to what extent? and (2) do potential protein degradation byproducts interfere with safety and efficacy of the drug? In order to ensure safety and quality of biological medicinal products there must be a collaboration between the clinicians, manufacturers, and regulators to better define detailed and clear guidelines for storage, reconstitution (if applicable), transfer to IV bags (if applicable), transporting, and all other steps of handling in the hospital setting. Additional trainings should be developed and delivered to healthcare professionals and patients to get the specific knowledge needed. There must be good communication between developers of protein pharmaceuticals and hospital pharmacies, allowing developers to obtain a better understanding of real-world conditions and handling of their protein drug products. Considerations regarding the stresses or combination of stresses that can occur during (mis)handling of the drug after it leaves the factory can become an integral part of the in-use studies in the drug product development process. Such practice would allow for identification of the main risk factors and can lead to putting the right emphasis on critical stress factors that matter the most in the guidelines for pharmacists and patients. Modern technologies can be invaluable tools on the one hand to gather and document data on what a drug product experiences beyond the release by the manufacturer and on the other one to deliver more effective trainings and communication to end users (52). Conclusion Progress in the development of biological medicinal products over the last two decades has brought a significant increase in knowledge and understanding of the influence of various stress factor on stability, resulting in good control of critical stability parameters during the production and distribution of biological medicinal products. Manufacturers should understand the consequences of temperature excursions during storage and transport of biological medicinal products from manufacturing site to patients. Temperature excursions observed at any stage of the pharmaceutical business should be reported and appropriately investigated. Manufacturers should assess whether available stability data are sufficient to resolve potential temperature excursions. If this is not the case, they should consider initiating additional stability studies that will support the release decision in the case of temperature excursion do not affect the medicinal product quality. Additional efforts should be made to understand the impact of various stress factors both during transport and in the phase of drug administration, hospital environment and patient and their impact on the quality of the biological medicinal product, to improve safe drug administration, that is in the interest of all interested parties including manufacturers, healthcare institutions, regulators and above all patients.