Formulation and Administration of Biological Medicinal Products”

Krämer, Irene; Thiesen, Judith; Astier, A.

doi:10.1007/s11095-020-02859-z

Cited by 20 publications

(6 citation statements)

References 34 publications

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“…The quality, performance and detection limit of Cr-kit depend on the affinity of the antibody [10]. In this study, a detection method for heavy metal chromium was established by high affinity antibody.…”

Section: Discussionmentioning

confidence: 99%

Establishment of chromium detecting kit and its application in sea water and seafood

et al. 2021

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Chromium is one of main pollution in sea water, and the establishment of detecting kit is the research hot topic. In this study, immunized mice were obtained by immunogen Cr3+-EDTA-BSA, and hybridoma strains that secrete Cr3+-EDTA monoclonal antibody were selected. Cr3+-EDTA mAb were prepared with in vivo method. Then, Cr-kit for measurement of chromium was developed, and its application was executed in sea water and seafood. Two hybridoma strains of A321 and A424 were screened. The Cr-kit standard curve of the linear range was 1.0—512 μg/L, and limit of detection was 1.0 μg/L. The average recovery rates Cr spiked in samples of sea water, clam and shrimp were 102.62%, 94.69% and 96.29%, which were accordance with the results of ICP-AES. Totally, Cr-kit was successfully developed and behaved broad application potential in sea water and seafood.

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Section: Discussionmentioning

confidence: 99%

Establishment of chromium detecting kit and its application in sea water and seafood

et al. 2021

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“…Це зі свого боку часто призводить до значної зміни профілю якості та імунологічної або антигенної реакції у пацієнтів [2]. Тому розробники біологічних лікарських засобів приділяють велику увагу пошуку різних методів стабілізації цієї категорії ліків для забезпечення належної якості, максимального профілю ефективності та безпеки пацієнтів [12].…”

Section: вступunclassified

Analysis of the use of excipients in medicines of biological origin

Kramar,

Kryvoviaz,

Tomashevska

et al. 2024

Rep. of Vinnytsia Nation. Med. Univ.

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Annotation. The development of protein products has a number of difficulties and uncertainties regarding the use of excipients due to the high instability of the active pharmaceutical ingredient. The aim of the study was to analyze the nomenclature of excipients in original medicines of biological origin and evidence-based information on general trends in their use in protein products. Based on the content analysis of scientific sources of pharmaceutical information using data from PubMed, Elsevier and Compendium scientific databases, the State Register of Medicines of Ukraine, the most common excipients in biological medicines available on the Ukrainian market were identified. It was found that the main categories of substances were: buffering agents, pH regulators, surfactants and lyoprotectants that ensure the stability of biological drugs, which are mostly represented by parenteral dosage forms. In these drugs, sodium phosphate, sodium hydroxide, hydrochloric acid are often used to stabilize pH, and histidine is used in monoclonal antibodies. To protect protein compositions from mechanical stresses, surfactants such as polysorbate 80 and polysorbate 20 were used in a larger percentage of preparations. Sugars such as sucrose, trehalose, lactose, sorbitol, mannitol, and glycine played an important role in protecting the protein from destabilizing conditions during the lyophilization process. Excipients that are typical only for protein products were found. In particular, phenol in polypeptide hormone formulations and methacresol in cytokine and growth factor formulations as antimicrobial preservatives; zinc and protamine sulfate in insulin formulations as stabilizers. Albumin as a stabilizer and solubilizer is present in preparations with cytokines and growth factors, toxins and some enzymes. Excipients, in addition to ensuring stability during transportation and use of biological drugs in various environmental conditions, affect their safety profiles and therefore require serious clinical consideration to improve the safety of these drugs.

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“…While microbial stability during clinical in-use is out of scope for this article, the reader is directed to a recent review article. 109 Another stress factor for IV infusion bags that is routinely missed is ambient light exposure for extended periods of time. Many biotechnology products have been shown to be light sensitive, even to ambient light that is devoid of significant UV wavelengths.…”

Section: Intravenous (Iv) Administrationmentioning

confidence: 99%

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

Narhi

Chou

Christian

et al. 2022

Journal of Pharmaceutical Sciences

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Formulation and Administration of Biological Medicinal Products”

Cited by 20 publications

References 34 publications

Establishment of chromium detecting kit and its application in sea water and seafood

Establishment of chromium detecting kit and its application in sea water and seafood

Analysis of the use of excipients in medicines of biological origin

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

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