Stress Factors in Primary Packaging, Transportation and Handling of Protein Drug Products and Their Impact on Product Quality

Narhi, Linda O.; Chou, Danny K.; Christian, Twinkle R.; Gibson, Scott L.; Jagannathan, Bharat; Jiskoot, Wim; Jordan, Susan; Sreedhara, Alavattam; Waxman, Lloyd; Das, Tapan K.

doi:10.1016/j.xphs.2022.01.011

Cited by 18 publications

(4 citation statements)

References 105 publications

(150 reference statements)

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“…Despite the SEIPS study showing in general a good level of information given to patients, the lack of knowledge about the storing and handling of drugs at home is at least worrying. Some authors have studied the storage conditions and range temperatures at patients’ homes regarding more investigation and solutions for these common situations [ 18 , 19 ].…”

Section: Discussionmentioning

confidence: 99%

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How are we handling protein drugs in hospitals? A human factors and systems engineering approach to compare two hospitals and suggest a best practice

Sabaté-Martínez,

Paulsson,

González-Suárez

et al. 2024

International Journal for Quality in Health Care

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Background Biopharmaceuticals are complex biological molecules that require careful storage and handling to ensure medication integrity. In this study, a work system analysis of real-world protein drug (PD) handling was performed with the following goals: identify main barriers and facilitators for successful adherence to accepted recommendations in PD handling, analyse differences in two organisations, and define a Best Current Practice in the real-life handling of PDs based on the results of the work system analysis. Methods Observational study held in two university hospitals in Spain and Sweden. Based on the Systems Engineering Initiative for Patient Safety (SEIPS) model, the tools chosen were: the PETT scan, in order to indicate the presence of barriers or facilitators for the PETT components (People, Environment, Tools, Tasks); the Tasks and tools matrices to construct a checklist to record direct observations during the real-life handling of biopharmaceuticals, and the Journey map to depict the work process.Observations were performed between March-November 2022. Each episode of direct observation included a single protein drug in some point of the supply chain and considered all the elements in the work system. Based on the results of the work system analysis and the literature review, the authors propose a list of items which could be assumed as Best Current Practice for PDs handling in hospitals. Results There were a total of 34 observations involving 19 PDs. Regarding People involved in the work process, there was a diversity of professionals with different previous training and knowledge, leading to an information gap. With respect to Environment, some structural and organizational differences between hospitals lead to risks related to the time exposure of PDs to room temperature and mechanical stress. Some differences also existed in the Tools and Tasks involved in the process, being especially relevant the lack of compatibility information of PDs with new technologies, such as pneumatic tube system, robotic reconstitution or closed-system transfer devices. Finally, 15 suggestions for best current practice are proposed. Conclusion Main barriers found for compliance with accepted recommendations were related to the information gap detected in professionals involved in the handling of protein drugs, unmonitored temperature and the lack of compatibility information of protein drugs with some new technologies. By applying a Human Factors and Systems Engineering Approach, the comparison of two European hospitals has led to a suggested list of Best Current Practices in the handling of protein drugs in a hospital.

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Section: Discussionmentioning

confidence: 99%

“…or Jiskoot et al . [ 6 , 19 ]. Excessive room temperature exposure or vial shaking is still observed during drug handling.…”

Section: Discussionmentioning

confidence: 99%

How are we handling protein drugs in hospitals? A human factors and systems engineering approach to compare two hospitals and suggest a best practice

Sabaté-Martínez,

Paulsson,

González-Suárez

et al. 2024

International Journal for Quality in Health Care

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“…For cycloolefin materials, the current polymerization mechanism is ring‐opening metathesis polymerization (ROMP), which is close to the common coordination polymerization of non‐cycloolefin, as shown in Scheme 1. In the study of ROMP, Grubbs catalyst is particularly popular in the scientific research circle due to its unreach catalytic activity and tolerance to water, oxygen and impurities [10–12] . However, it has high cost and is not very promising for industrialization under current conditions.…”

Section: Introductionmentioning

confidence: 99%

“…In the study of ROMP, Grubbs catalyst is particularly popular in the scientific research circle due to its unreach catalytic activity and tolerance to water, oxygen and impurities. [10][11][12] However, it has high cost and is not very promising for industrialization under current conditions. Therefore, traditional Ziegler-Natta catalyst has to be relied on in the industrial production of cycloolefin materials.…”

Section: Introductionmentioning

confidence: 99%

Effect of Ligand Steric Hindrance on Catalytic Polymerization of Cycloolefin Polymer (COP)

Zhang

Fang

Huang³

et al. 2023

ChemistrySelect

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The traditional two‐component Ziegler‐Natta catalyst has low catalytic activity when initiating ring‐opening metathesis polymerization (ROMP) and is unstable and easy to generate polymerization gels. Therefore, it is necessary to add a third group of ligands with appropriate steric hindrance to improve the catalytic activity of the catalyst. The effects of ligands′ steric hindrance and other reaction conditions on the catalytic activity of tungsten hexachloride (WCl6) as catalyst and aluminum triethyl (AlEt3) as co‐catalyst were investigated. The results showed that the size of the ligands′ steric hindrance affected the catalytic activity of ROMP, and the small steric hindrance caused the polymerization rate to be too fast, which was easy to produce gels, and when the steric hindrance of the ligands was too large, its solubility was not good, which was not conducive to the normal polymerization. When stearyl alcohol was selected as the ligand, the highest catalytic activity was 3123 mol cycloolefin polymer (COP)/mol W, and the reaction speed of polymerization was also the fastest and the complete transformation only needed 30 min when the ligand/W was 25. It was found that the polymerization reaction was stable without gels and the obtained polymer molecular weight was appropriate, 17.8 kDa, under the conditions of Al/W=80, reaction temperature 60 °C, monomer concentration 10 w/v %, catalyst/monomer 5*10−4 : 1, chain transfer agent/monomer 0.005 : 1.

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Design of a Corporate Training Academy: The Case Study of a Pharmaceutical Company

Marques,

Ramos,

Mota

2023

Springer Proceedings in Mathematics &Amp; Statistics

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Stress Factors in Primary Packaging, Transportation and Handling of Protein Drug Products and Their Impact on Product Quality

Cited by 18 publications

References 105 publications

How are we handling protein drugs in hospitals? A human factors and systems engineering approach to compare two hospitals and suggest a best practice

How are we handling protein drugs in hospitals? A human factors and systems engineering approach to compare two hospitals and suggest a best practice

Effect of Ligand Steric Hindrance on Catalytic Polymerization of Cycloolefin Polymer (COP)

Design of a Corporate Training Academy: The Case Study of a Pharmaceutical Company

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