NEW SUPPLY CHAIN PARADIGM TO STRENGTHEN THE BIOTECHNOLOGY-BASED PHARMACEUTICAL INDUSTRY
- 1Hemobrás, Goiana, PE, Brazil
- 2Hemobrás, Recife, PE, Brazil
Abstract
Introduction: The pharmaceutical supply chain (SC) is extremely complex and highly regulated. It comprises an integrated network of stages, resources, and processes responsible for planning, manufacturing, and transporting medicines and inputs, extending from suppliers to the patient. The production of biotechnological medicines (BMs) involves the procurement of pharmaceutical inputs, Sales and Operations Planning (S&OP), quality control, and the biotechnological processing required for drug manufacturing. Objective: To analyze the structure of the pharmaceutical SC in Brazil and evaluate the factors influencing BM production. Materials and Methods: An integrative review was conducted using PubMed, ScienceDirect, and the AnvisaLegis, covering articles and regulatory standards published between 2020 and 2026.Results and Discussion: An evolution from traditional logistics to a pharmaceutical SC model was observed in industries producing BMs. This shift was driven by the convergence of four major factors. The first relates to the increasing complexity of BMs, advancements in biotechnology have consolidated the transition from simple synthetic drugs to complex biological products, such as monoclonal antibodies, blood-derived products, and recombinant proteins. Due to the high thermosensitivity of these BMs, rigorous temperature control became necessary to prevent protein denaturation and the inactivation of the active pharmaceutical ingredient (API), necessitating a complete restructuring of the cold chain. The second factor was the evolution of sanitary responsibility, making manufacturers and distributors jointly accountable for product integrity up to the point of final delivery. The third factor concerns ANVISA’s integration into the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which drove the alignment of Brazilian regulations with stricter global standards. The fourth factor lies in supply chain vulnerability, the concentration of API production in a few countries, such as India and China, combined with the potential for conflicts or health crises, creates instability and risks halting healthcare systems. In this context, these elements catalyzed the updating of regulations and the establishment of state policies, such as the Health Economic-Industrial Complex (CEIS). While RDC 430/2020 established Good Distribution, Storage, and Transport Practices for medicines, fostering the use of technologies such as telemetry, qualification, and risk management, the CEIS solidified its role as a public policy aimed at reducing external dependency and stimulating the domestic production of APIs, pharmaceutical inputs and medicines strategic to the Unified Health System (SUS). Conclusion: Thus, it can be concluded that advances in the production of biological medicines, regulatory changes, and the risk of API supply shortages constitute a set of factors that drove the transition from a traditional logistics model toward the development of a robust pharmaceutical supply chain focused on medicine quality and industrial sovereignty.
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BibTeX
@article{leao2026supply,
title = {{NEW SUPPLY CHAIN PARADIGM TO STRENGTHEN THE BIOTECHNOLOGY-BASED PHARMACEUTICAL INDUSTRY}},
author = {Amanda Damasceno LEÃO and Laianne Carla Batista ALENCAR and Raquel Gois BASTOS},
journal = {Hematology, Transfusion and Cell Therapy},
year = {2026},
month = oct,
doi = {10.1016/j.htct.2026.108185},
url = {https://doi.org/10.1016/j.htct.2026.108185},
note = {CC BY},
}
RIS
TY - JOUR
TI - NEW SUPPLY CHAIN PARADIGM TO STRENGTHEN THE BIOTECHNOLOGY-BASED PHARMACEUTICAL INDUSTRY
AU - Amanda Damasceno LEÃO
AU - Laianne Carla Batista ALENCAR
AU - Raquel Gois BASTOS
PY - 2026
DA - 2026/10/23
JO - Hematology, Transfusion and Cell Therapy
DO - 10.1016/j.htct.2026.108185
UR - https://doi.org/10.1016/j.htct.2026.108185
AB - Introduction: The pharmaceutical supply chain (SC) is extremely complex and highly regulated. It comprises an integrated network of stages, resources, and processes responsible for planning, manufacturing, and transporting medicines and inputs, extending from suppliers to the patient. The production of biotechnological medicines (BMs) involves the procurement of pharmaceutical inputs, Sales and Operations Planning (S&OP), quality control, and the biotechnological processing required for drug manufacturing. Objective: To analyze the structure of the pharmaceutical SC in Brazil and evaluate the factors influencing BM production. Materials and Methods: An integrative review was conducted using PubMed, ScienceDirect, and the AnvisaLegis, covering articles and regulatory standards published between 2020 and 2026.Results and Discussion: An evolution from traditional logistics to a pharmaceutical SC model was observed in industries producing BMs. This shift was driven by the convergence of four major factors. The first relates to the increasing complexity of BMs, advancements in biotechnology have consolidated the transition from simple synthetic drugs to complex biological products, such as monoclonal antibodies, blood-derived products, and recombinant proteins. Due to the high thermosensitivity of these BMs, rigorous temperature control became necessary to prevent protein denaturation and the inactivation of the active pharmaceutical ingredient (API), necessitating a complete restructuring of the cold chain. The second factor was the evolution of sanitary responsibility, making manufacturers and distributors jointly accountable for product integrity up to the point of final delivery. The third factor concerns ANVISA’s integration into the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which drove the alignment of Brazilian regulations with stricter global standards. The fourth factor lies in supply chain vulnerability, the concentration of API production in a few countries, such as India and China, combined with the potential for conflicts or health crises, creates instability and risks halting healthcare systems. In this context, these elements catalyzed the updating of regulations and the establishment of state policies, such as the Health Economic-Industrial Complex (CEIS). While RDC 430/2020 established Good Distribution, Storage, and Transport Practices for medicines, fostering the use of technologies such as telemetry, qualification, and risk management, the CEIS solidified its role as a public policy aimed at reducing external dependency and stimulating the domestic production of APIs, pharmaceutical inputs and medicines strategic to the Unified Health System (SUS). Conclusion: Thus, it can be concluded that advances in the production of biological medicines, regulatory changes, and the risk of API supply shortages constitute a set of factors that drove the transition from a traditional logistics model toward the development of a robust pharmaceutical supply chain focused on medicine quality and industrial sovereignty.
SN - 2531-1379
SN - 2531-1387
ER -