Bacterial endotoxin detection in hyaluronic acid-based medical devices

Baeva, Larissa F.; Das, Srilekha Sarkar; Hitchins, Victoria M.

doi:10.1002/jbm.b.33659

Cited by 12 publications

(7 citation statements)

References 13 publications

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“…Finally, microbial limits, endotoxins and pyrogens are enlisted. These contaminants (especially endotoxins and proteins) are not eliminated during sterilization and may be present in the finalized product (Baeva et al, 2017 ).…”

Section: Physico-chemical Characterization Of Native Hamentioning

confidence: 99%

An Effective Translation: The Development of Hyaluronan-Based Medical Products From the Physicochemical, and Preclinical Aspects

Huerta-Ángeles

Nešporová

Ambrožová

et al. 2018

Front. Bioeng. Biotechnol.

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This review shows the steps toward material selection focalized on the design and development of medical devices based on hyaluronan (HA). The selection is based on chemical and mechanical properties, biocompatibility, sterilization, safety, and scale-up costs. These facts play a vital role in the industrialization process. Approved medical devices containing-HA are illustrated to identify key parameters. The first part of this work involves the steps toward a complete characterization of chemical and mechanical aspects, reproducibility of the processes and scale up. In a second stage, we aimed to describe the preclinical in vitro and in vivo assays and selected examples of clinical trials. Furthermore, it is important to keep in mind the regulatory affairs during the research and development (R&D) using standardization (ISO standards) to achieve the main goal, which is the functionality and safety of the final device. To keep reproducible experimental data to prepare an efficient master file for the device, based on quality and recorded manufacturing data, and a rigorous R&D process may help toward clinical translation. A strong debate is still going on because the denominated basic research in HA field does not pay attention to the purity and quality of the raw materials used during the development. So that, to achieve the next generation of devices is needed to overcome the limitations of state of art in terms of efficacy, biodegradability, and non-toxicity.

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Section: Physico-chemical Characterization Of Native Hamentioning

confidence: 99%

An Effective Translation: The Development of Hyaluronan-Based Medical Products From the Physicochemical, and Preclinical Aspects

Huerta-Ángeles

Nešporová

Ambrožová

et al. 2018

Front. Bioeng. Biotechnol.

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“…Bacterial products (e.g., lipopolysaccharide, peptidoglycan, or other various lipopeptides) may still induce pathologic changes via immunologic mechanisms leading to tissue damage despite potential non‐viability. Hyaluronic‐based medical devices, such as OVDs, may be contaminated with bacterial endotoxin (LPS) during the manufacturing process 38 . In a study evaluating ocular reactivity following intracameral injection of endotoxin spiked‐OVDs in rabbits, intraocular inflammation was observed after as little as 0.02 EU in eyes that received OVDs.…”

Section: Discussionmentioning

confidence: 99%

“…Hyaluronic-based medical devices, such as OVDs, may be contaminated with bacterial endotoxin (LPS) during the manufacturing process. 38 In a study evaluating ocular reactivity following intracameral injection of endotoxin spiked-OVDs in rabbits, intraocular inflammation was observed after as little as 0.02 EU in eyes that received OVDs. The observed responses to the intracamerally injected endotoxin in OVDs was more severe with a longer duration than aqueous-based injected mediums.…”

Section: F I G U R Ementioning

confidence: 99%

“…Hyaluronidases were not utilized in the endotoxin quantification arm of this study to break down the hyaluronate molecule and improve accessibility for the LAL assay. 38 Future studies may utilize commercially available hyaluronidases to improve accuracy in endotoxin detection in viscous medical devices, such as OVDs. It is possible that the LAL assay in this study underestimated the amount of endotoxin in the OVDs without the use of hyaluronidases.…”

Section: F I G U R Ementioning

confidence: 99%

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Ophthalmic viscoelastics commonly used in cataract surgery: A microbiota investigation

Dowler

Vientós‐Plotts

Giuliano

et al. 2023

Veterinary Ophthalmology

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Purpose To survey commonly used, sterile ophthalmic viscoelastic materials used during routine cataract surgery for the presence of bacterial DNA and/or viable bacteria and endotoxin quantification. Methods Samples from three different ophthalmic viscoelastic manufacturers and three different production lots per manufacturer were collected for 16 S ribosomal ribonucleic acid (rRNA) sequencing and conventional aerobic and capnophilic bacterial culture. Other samples of viscoelastic material from the same three manufacturers were collected for endotoxin quantification using a commercially available Limulus amebocyte lysate (LAL) assay. Statistical analysis was performed using Sigma Plot 14.0, and R v4.0.2.0. Differences (p ≤ .05) between sample collection sites in total DNA concentration, microbial richness, mean intra‐group distances, and endotoxin quantification alongside reagent controls were evaluated. Results Culture yielded two isolates, identified as Staphylococcus epidermidis and Bacillus megaterium. 16 S rRNA sequencing revealed no differences between brands in richness or overall composition. The most common bacterial DNA detected across all brands was Staphylococcus sp., Cutibacterium sp., Flavobacterium sp., and Lactobacillus sp. A significant difference was found between the median endotoxin concentration between Anvision and Hyvisc® viscoelastic (Anvision: 0.171 EU/mL, Hyvisc®: 0.03 EU/mL; p < .001). Conclusions No brand‐specific differences in bacterial DNA were detected in the viscoelastic materials. Staphylococcus, Cutibacterium, Flavobacterium, and Lactobacillus were the dominant contributors to the bacterial DNA detected. Although Anvision viscoelastic samples contained significantly more endotoxin than Hyvisc® viscoelastic samples, endotoxin concentrations were below the FDA limit of 0.2 EU/mL for both manufacturers. These data further the understanding of inflammatory outcomes following cataract surgery.

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“…The other aspect to consider is the level of bacteria and endotoxin in the starting HA material, since most commercially-available HA is synthesized using microbial culture [43]. Interestingly, one study (from 2017) found that even the pharmaceutical- and-research-grade HA contained trace levels of endotoxin [44], which were similar to levels found in the cosmetic-grade HA reported in the product specification sheet used in this study (provided by CosChemSupply, Rancho Cucamonga, California).…”

Section: Discussionmentioning

confidence: 99%

Cost-Effective Cosmetic-Grade Hyaluronan Hydrogels for ReNcell VM Human Neural Stem Cell Culture

Suh

2019

Biomolecules

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Hyaluronic acid (HA) is a polysaccharide polymer frequently used as a starting material to fabricate hydrogels, especially for recapitulating the brain’s extracellular matrix (ECM) for in vitro neural stem cell (NSC) cultures. Here, we report the successful synthesis of a methacrylated HA (MeHA) polymer from an inexpensive cosmetic-grade hyaluronan starting material. The MeHA polymers synthesized from cosmetic-grade HA yielded similar chemical purity to those from pharmaceutical/research-grade HA reported in the literature. Crosslinked MeHA (x-MeHA) hydrogels were formed using radical polymerization which resulted in mechanical properties matching previously reported mechanical property ranges for enhanced neuronal differentiation of NSCs. We assessed cellular adhesion, spreading, proliferation, and stiffness-dependent neuronal differentiation properties of ReNcell VM human neural stem cells (hNSCs) and compared our results to studies reported in the literature (that utilized non-human and human pluripotent cell-derived NSCs).

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Bacterial endotoxin detection in hyaluronic acid-based medical devices

Cited by 12 publications

References 13 publications

An Effective Translation: The Development of Hyaluronan-Based Medical Products From the Physicochemical, and Preclinical Aspects

An Effective Translation: The Development of Hyaluronan-Based Medical Products From the Physicochemical, and Preclinical Aspects

Ophthalmic viscoelastics commonly used in cataract surgery: A microbiota investigation

Cost-Effective Cosmetic-Grade Hyaluronan Hydrogels for ReNcell VM Human Neural Stem Cell Culture

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