5D Health Protection Group Ltd

Biologics

We work on many areas in the biologics field particularly in the interdisciplinary field of regenerative medicine. Regenerative medicine employs a variety of different scientific disciplines including engineering and life sciences. Medical devices such as tissue scaffolds and cell based therapies form an important element of regenerative therapies. Regenerative products are used in many areas such as skin and woundcare, dentistry and for orthopaedic applications.

The development of regenerative technologies and products requires specialised support from scientists with knowledge in this area. Our biologics analysis and development scientific support services are here to support your product research, innovation and development. Our experience spans many areas including skin, bone, biomaterials and stem cell technology.

5D Bioservices

5D offer a broad range of test, models and assays that fall into the 5D biologics area of testing which are carried out in our biologics and cellular laboratories.

Matrix Metalloproteinase (MMP) Detection and Measurement

Matrix metalloproteinases are a family of zinc-dependent proteolytic enzymes that are associated with the degradation and turnover of the extracellular matrix (ECM). The ECM is composed of collagen, fibronectin and laminin. MMP expression in human tissue is normally quite low. Levels increase in numerous pathological conditions which can lead to tissue destruction, inflammation and infection. In wound healing high levels of MMPs can be detrimental to wound healing. At 5D we are able to measure the levels of MMPs and investigate technologies for their ability to regulate, inhibit or stop the activity of MMPs.

Bacterial Endotoxin Testing

Bacterial endotoxins is a cell-associated bacterial toxin. They are the lipopolysaccharide complex associated with the outer membrane of Gram negative bacteria such as Pseudomonas aeruginosa and Escherichia coli.

To measure of endotoxins we use a number of assays including the Limulus Amoebocyte Lysate (LAL) assay which is an established pharmacopeia method for the screening of irrigation fluid, dialysis solutions etc. This assay is often used to assess medical device safety which are used for direct and indirect contact to body fluids.

We are able to offer 3 standard test methods including the gel clot method (limit test or semi-quantitative (Method A and B of the European Pharmacopoeia), the kinetic turbidimetric method (Method C of the European Pharmacopeia), kinetic chromogenic method (Method D of the European Pharmacopeia) and the Recombinant Factor C.

Exotoxin Testing

Exotoxins are soluble proteins that are released from bacteria that enter host cells and cause damage to cells. They are able to cause the disruption of cellular activities and metabolism of the hosts cells.

Exotoxins do vary in their potency. Examples of exotoxins include exotoxin A from Pseudomonas aeruginosa and toxic shock syndrome toxin-1 (TSST-1) secreted by Staphylococcus aureus.

Whilst exotoxins are released from bacteria they can also be released when bacteria die. 5D are able to measure exotoxins and for our customers we also determine what affects their products have on exotoxin production and wether their products are able to cause the breakdown of exotoxins or bind onto them and so reduce their activity.

Many wound dressings for examples have the ability to sequester and 'lock away' toxins so they are not available to cause damage to human cells.

Monocyte Activation Testing (MAT)

This in vitro test (European Pharmacopoeia 8.8 (2016, 2.6.30) is used to test for the pyrogenicity of medical devices. A pyrogen is a substance that causes and increase in temperature in animals and humans. Exogenous pyrogens induce fever. Endogenous pyrogens include IL-1, IL-6, IL-12 and TNF-alpha that are produced by the body when it comes into contact with pyrogens. Contamination of pyrogenic agents can occur during the production and manufacturing of medical devices.

Exogenous pyrogens can be endotoxins from Gram-negative bacteria, peptidoglycan, lipoteichoic acids and bacterial lipoproteins, viral pyrogens, pyrogens from yeast and fungi. Sterile products must be free of pyrogens.

For the detection of endotoxins we use the bacterial endotoxin test (BET) or the Limulus Amebocyte Lysate (LAL) test and the recombinant Factor C (rFC). Testing for pyrogens include the Mat test.

Inflammatory and Immunological Testing and Analysis

5D are able to offer a broad array of different immunology based assays. In particular we have developed and undertake cytokine release assays.

For example, we are able to evaluate the stimulation of peripheral blood mononuclear cells, analyse and measure cytokines such as IFN, tumor necrosis factor-α (TNF- α, IL-10. IL-1-beta, IL-12p70 and other markers that are required by our customers.

Immunohistochemistry and Immunocytochemistry analysis

Immunohistochemistry involves the use and techniques that are used to both determine the presence and levels of specific proteins. We also utilise immunofluorescence assays that are used to analyse the distribution of proteins and also biological and non-biological agents in cells and tissues.

Macrophage activation

Macrophage activation involves the measurement of cytokines and other products such as prostanoids and chemokines.

Growth factor measurement

5D are able to measure and detect the effects of different products on an array of different growth factors. Please contact 5D to discuss your needs to evaluate the effects of medical devices on growth factor upregulation and down regulation.

Haemolysis and Haemostasis

Heamolysis is the rupturing of red blood cells and the release of red blood cell contents. It is important that medical devices are evaluated to see if they cause the haemolysis of red blood cells. Haemostasis is the process of stopping bleeding. Please call to discuss our test methods that are used to evaluate if your products can achieve haemostats or haemolysis.

Histopathology and Histological analysis

Histopathology is the microscopic identification of diseases tissue. We utilise an array of different microscopic techniques and staining techniques for the analysis of cells and tissue.

For example we employ the use of H&E stains, Gram stains, Movat Pentachrome methods (staining of collagen, elastin and fibrin), and Modified Verhoff Elastin Van Gieson Stains.

We use different microscopes including confocal laser microscopy, scanning electron microscopy, transmission electron microscopy and also atomic force microscopic for our customer.

To discuss your scientific testing needs please contact us at info@5Dhpg.com or call on +44 (0) 151 794 9279.