Serum eye drop preparation in Australia: Current manufacturing practice

Marks, Denese C.; Fisher, Jenny; Mondy, Phillip; Segatchian, Jerard; Dennington, Peta M.

doi:10.1016/j.transci.2015.05.015

Cited by 15 publications

(14 citation statements)

References 26 publications

(27 reference statements)

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“…Eye drops made of human serum have emerged as an alternative and probably superior treatment of DES [ 6 , 11 , 38 , 39 ]. SED preparations from autologous sources have so far been used most frequently [ 5 , 6 , 14 , 15 ], and standardized preparation procedures using a closed cascade filtration system were developed [ 40 ]. However, there is a trend towards using allogeneic, off-the-shelf SEDs prepared under controlled GMP conditions by blood establishments [ 20 , 41 ].…”

Section: Discussionmentioning

confidence: 99%

“…SEDs are currently most often prepared from autologous blood donations within hospitals or blood establishments [ 14 , 15 ]. However, preparing autologous serum requires particular attention and repeated blood samplings from patients, which is a constraint, and thus is potentially impossible in some clinical situations where patients are not in a condition or willing to donate blood.…”

Section: Introductionmentioning

confidence: 99%

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Solvent/Detergent Virally Inactivated Serum Eye Drops Restore Healthy Ocular Epithelium in a Rabbit Model of Dry-Eye Syndrome

et al. 2016

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Application of autologous serum eye drops (SEDs) is a recognized means to treat severe dry-eye syndrome (DES). Due to the inconvenience and difficulty of preparing SEDs from some patients, producing SEDs from allogeneic blood donations is gaining popularity. A major safety concern associated with allogeneic blood is virus transmission. We therefore herein evaluated the possibility of applying a solvent/detergent (S/D) treatment to inactivate viruses and studied the impacts of such treatment of SEDs to resolve DES in a rabbit model. Sera prepared from the blood of five rabbits were pooled and divided into two sub-pools. One was untreated (SEDs), while the other was virally-inactivated with 1% Tri-n-butyl phosphate/1% Triton X-45 at 31°C for 1 h (S/D-SEDs). DES was induced in rabbits using 0.1% benzalkonium chloride (BAC). Rabbits were divided into five groups of two rabbits each. One group was untreated (control), three were treated twice daily for 3 weeks using PBS, SEDs, or S/D-SEDs, and the last received an additional 0.1% BAC (as the negative control). The DES condition was determined by measuring aqueous tear secretion (Schirmer’s test), corneal fluorescein staining, a corneal histologic examination, TUNEL stain apoptosis, and corneal inflammatory marker (tumor necrosis factor-α, interleukin (IL)-1β, IL-8, and IL-6) expressions. We first confirmed that SEDs and S/D-SEDs had similar protein profiles and transforming growth factor (TGF)-β contents. Animal experiments showed that tear secretion did not significantly differ between the SED and S/D-SED groups but was significantly higher than in the PBS group. Eye fluorescein staining revealed dramatic improvements in epithelial defects in groups treated with SEDs or S/D-SEDs, and hematoxylin/eosin staining revealed microscopic epithelial layers similar to those of the untreated controls. Inflammatory markers and TUNEL studies showed that healthy epithelium had been restored in groups treated with SEDs or S/D-SEDs. In conclusion, this preclinical study supports the possibility of using S/D virally inactivated SEDs to treat DES and restore a normal epithelium.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Solvent/Detergent Virally Inactivated Serum Eye Drops Restore Healthy Ocular Epithelium in a Rabbit Model of Dry-Eye Syndrome

et al. 2016

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“…Very few cases of adverse events related to contamination have been reported in the literature (reviewed in Reference [44]). To improve safety, sealed manufacturing systems (which package the eye drops into vials or long lengths of tubing, which are then heat-sealed to produce single-use devices) have been proposed in the market [45,46,47], but financial and logistic barriers are still unaffordable in many centers [48].…”

Section: Autologous Serum Eye Dropsmentioning

confidence: 99%

Blood-Based Treatments for Severe Dry Eye Disease: The Need of a Consensus

Bernabei

Roda

Buzzi

et al. 2019

JCM

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The use of blood-based eye drops as therapy for various diseases of the ocular surface has become increasingly popular in ophthalmic practice during recent years. The rationale for their use is based on the promotion of cellular proliferation and migration thanks to the supply of metabolically active substances, in particular growth factors. Blood-derived eye drops have been used for the treatment of several ocular surface disorders, such as dry eye disease, corneal ulcer, persistent epithelial defect, neurotrophic keratitis, ocular surface burn, recurrent corneal erosion, and limbal stem-cell deficiency. Both autologous (from patients themselves) and heterologous (from adult donors or from cord blood sampled at birth)-derived products exist, and each source has specific pros and cons. Despite an extensive literature, several issues are still under debate and the aim of this manuscript is to review the indications, preparation methods and storage, characterization of content, rationale for clinical outcomes, patient stratification, length of treatment, and rationale for repeated treatments at disease relapse. A rationale based on a “5 Ws and 2 Hs” protocol is proposed as a way of thinking, with the attempt to clarify Who, Why, When, Where, What, and How to use these treatment options.

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“…In Australia, the Red Cross Blood Service manufactures and distributes autologous serum eye drops to eligible patients with dry eye, persistent corneal epithelial defects, and nonhealing corneal ulcers. 44 Since 2005, the Blood Service has collected whole blood from patients for the manufacturing of serum eye drops using a national, standardized process to produce 20% of serum drops. Demand for serum eye drops in Australia is increasing every year, with a 30% increase in 12 months during 2014 to 2015.…”

Section: Autologous Serum Eye Drops and Other Therapeutic Interventiomentioning

confidence: 99%

“…Demand for serum eye drops in Australia is increasing every year, with a 30% increase in 12 months during 2014 to 2015. 44 Based on the results of these studies, it can be concluded that autologous serum eye drops are a wellestablished treatment for dry eye disease.…”

Section: Autologous Serum Eye Drops and Other Therapeutic Interventiomentioning

confidence: 99%

Autologous Serum and Serum Components

Higuchi

2018

Invest. Ophthalmol. Vis. Sci.

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Dry eye syndrome is a multifactorial condition on the tear and ocular surface. Autologous serum eye drop is an effective method for treating dry eye. Autologous serum eye drops are now widely used by specialists since a first report in 1975. The results of a systematic study showed that the efficacy of autologous serum eye drops remains ambiguous because its preparation methods and clinical application have not been standardized. To elucidate the efficacy of autologous serum eye drops, well-designed, large-scale, high-quality randomized controlled trials need to be conducted with standardized treatment and use. Since serum components are partially similar to tear components, autologous serum eye drops improve dry eye by supplying tear components such as growth factors, proteins, and vitamins. Adding to the evidence based on the treatment of dry eye, we have found a new treatment candidate from serum: selenoprotein P (SeP). The efficacy of SeP as a treatment for dry eye was revealed by applying SeP eye drops to a dry eye rat model. Compared with phosphate-buffered saline treatment, SeP eye drops significantly reduced the fluorescein score of the cornea and suppressed the oxidative stress in the cornea, which is related to onset of dry eye, leading to improved corneal disorder. We have developed a new dry eye model caused by oxidative stress that will be used to screen candidate molecules for antioxidative activity.

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Serum eye drop preparation in Australia: Current manufacturing practice

Cited by 15 publications

References 26 publications

Solvent/Detergent Virally Inactivated Serum Eye Drops Restore Healthy Ocular Epithelium in a Rabbit Model of Dry-Eye Syndrome

Solvent/Detergent Virally Inactivated Serum Eye Drops Restore Healthy Ocular Epithelium in a Rabbit Model of Dry-Eye Syndrome

Blood-Based Treatments for Severe Dry Eye Disease: The Need of a Consensus

Autologous Serum and Serum Components

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