Pharmaceutical supply chain reliability and effects on drug shortages

Tucker, Emily L.; Daskin, Mark S.

doi:10.1016/j.cie.2022.108258

Cited by 15 publications

(9 citation statements)

References 51 publications

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“…Then, LuxI synthesises N-acyl homoserine lactone molecules (AHL) as autoinducer signals. The dynamic model (1) captures this cell-to-cell communication mechanism among every q − th cell in a population of N cells. At low cell densities, intracellular AHL molecules diffuse passively out of the cell down a concentration gradient across its C. Signals from the biocontroller components (sigma, antigisma, RNAi, and peptidoglycans).…”

Section: Quorum Sensing-based Circuitmentioning

confidence: 99%

“…The higher the cell density N , the larger the AHL level and the faster quorum sensing will start. The extracellular environment in ODE model (1) interplays with the intracellular environment through expressions in (2) for every q − th cell. We also can quantify the required conditions of LuxR, LuxI, AHL with the expressions in (2).…”

Section: Quorum Sensing-based Circuitmentioning

confidence: 99%

“…The global pharmaceutical industry faces significant challenges, including reliance on imported components for drug manufacturing, supply chain disruptions, and the need for sustainable and efficient production methods [1,2]. Among these challenges, the exploration of alternative sources and innovative manufacturing approaches has become imperative to meet the growing demand for pharmaceutical products worldwide [3,4].…”

Section: Introductionmentioning

confidence: 99%

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Synthetic biology design principles enable efficient bioproduction of Heparosan with low polydispersion index for the biomedical industry

Boada,

Vázquez,

Córdova

et al. 2024

Preprint

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Heparosan, a natural polymer with unique chemical and biological properties, holds great promise for various biomedical applications. Of particular interest is the production of low molecular weight and low polydisperse heparosan polymers, which offer enhanced functionality and suitability for therapeutic and diagnostic purposes. Polydispersity, a measure of the distribution of molecular weight within a polymer sample, is a critical factor influencing the performance of heparosan-based materials. Achieving precise control over the synthesis process to consistently produce heparosan with low molecular weight and low polydispersity index can be challenging, requiring tight regulation of reaction conditions, enzyme activity, and precursor concentrations. To address this challenge, we propose a novel approach utilizing synthetic biology principles to precisely control heparosan biosynthesis in Escherichia coli (E. coli). Our strategy involves the design and implementation of a biomolecular controller capable of regulating the expression of genes involved in heparosan biosynthesis using biosensors of both precursors, thereby enabling fine-tuned control over the polymerization process. Through this approach, we successfully envision the implementation of the proposed system, demonstrating the potential to produce heparosan in probiotic E. coli Nissle 1917 with a low Mw and a low PDI that meets the stringent quality standards required for biomedical applications. This study represents a significant advancement in the field of heparosan production, offering new opportunities for the development of advanced biomaterials with tailored properties for diverse biomedical applications.

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Section: Quorum Sensing-based Circuitmentioning

confidence: 99%

Section: Quorum Sensing-based Circuitmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Synthetic biology design principles enable efficient bioproduction of Heparosan with low polydispersion index for the biomedical industry

Boada,

Vázquez,

Córdova

et al. 2024

Preprint

View full text Add to dashboard Cite

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“…Tucker et al (2020b) develop different supply chain models to consider disruptions and analyze the impact of alternatives incentives and their impact on increasing resilience (e.g. penalties; mandatory redundancy, safety stock and price increases), and Tucker and Daskin (2022) extend this work by analyzing mitigation approaches to improve pharmaceutical supply chain reliability. Operational measures to increase resilience in a pharmaceutical supply chain are studied by L€ ucker and Seifert (2017).…”

Section: Literature Reviewmentioning

confidence: 99%

On the drivers of drug shortages: empirical evidence from Germany

Francas

Mohr

Hoberg

2023

IJOPM

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PurposeDisruptions and shortages of drugs have become severe problems in recent years, which has triggered strong media and public interest in the topic. However, little is known about the factors that can be associated with the increased frequency of shortages. In this paper, the authors analyze the drivers of drug shortages using empirical data for Germany, the fourth largest pharmaceutical market.Design/methodology/approachThe authors use a dataset provided by the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM]) with 425 reported shortages for drug substances (DSs) in the 24-month period between May 2017 and April 2019 and enrich the data with information from additional sources. Using logistic and negative binomial regression models, the authors analyze the impact of (1) market characteristics, (2) drug substance characteristics and (3) regulatory characteristics on the likelihood of a shortage.FindingsThe authors find that factors like market concentration, patent situation, manufacturing processes or dosage form are significantly associated with the odds of a shortage. The authors discuss the implications of these findings to reduce the frequency and severity of shortages.Originality/valueThe authors contribute to the empirical research on drug shortages by analyzing the impact of market characteristics, DS characteristics and regulatory characteristics on the reported shortages. The authors’ analysis provides a starting point for better prioritizing efforts to strengthen drug supply as it is currently intensely discussed healthcare authorities.

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“…The Royal Pharmaceutical Society (RPS; professional body of pharmacists in the UK) also stated in 2022 that its members reported that the issue of drug shortages was a regular occurrence. In a Finnish study conducted in 2015, 129 community pharmacies were surveyed and reported to be experiencing drug shortages on a regular basis without apparent reasons [28]. The issue of drug shortages was also noted in a Polish study in 2020, which surveyed 435 pharmacists and found drug shortages to be a regular problem [29].…”

Section: Introductionmentioning

confidence: 97%

Exploring Drug Shortages in the United Kingdom

Obiedalla,

Patel,

Donyai

2023

Pharmacy

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Drugs can become short in supply for many reasons including increased demand and reduced production. Drug shortages have the potential to impact patients and pharmacists. This study aimed to highlight the challenges pharmacists face and the constraints of how they manage drug shortages. An online survey was designed with its link distributed electronically to community pharmacists in the UK with the assistance of pharmacy organizations during the period from September to December 2021. Survey data were analysed using descriptive statistics. A total of 83% of the respondents (n= 100) were experiencing drug shortages three or more times per week, and more than 70% of these spent 1–3 h per week dealing with them. A total of 93% of the respondents indicated that the issue of drug shortages was a problem for them, and 61% reported that it has worsened since the start of the pandemic. In addition, 65% of the respondents believed that drug shortages had had an impact on patient care. Drug shortages were shown to impact on the pharmacists’ workloads with a potential to affect the quality of patient care. There was a variation between how pharmacists dealt with drug shortages, which needs to be explored further with the reasons behind it.

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Pharmaceutical supply chain reliability and effects on drug shortages

Cited by 15 publications

References 51 publications

Synthetic biology design principles enable efficient bioproduction of Heparosan with low polydispersion index for the biomedical industry

Synthetic biology design principles enable efficient bioproduction of Heparosan with low polydispersion index for the biomedical industry

On the drivers of drug shortages: empirical evidence from Germany

Exploring Drug Shortages in the United Kingdom

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