Medical devices which are designed to enhance patients’ lives can be susceptible to microbial infection. Rather than improving the quality of life for that patient, it can result in a number of healthcare problems including local and systemic infection, implant replacement, patient pain and discomfort and associated healthcare costs. Perfectus Biomed Group continues to innovate to support your research and development helping you to identify, simulate and control microbial infection.
Perfectus Biomed specialise in tailoring antimicrobial assays and performing customised, accredited biofilm methodologies to study infections relating to medical implants such as catheters, stents, joint prostheses and external media such as wound dressings. We offer a range of test methods, including coating efficacy, endotoxin detection, bioburden assessment and implantable device assessment. We also carry out safety and efficacy testing to AATCC, BS EN and ASTM standards and can even modify the AATCC 100 method for organisms such as Methicillin-resistant Staphylococcus aureus (MRSA) to assess your product against tougher, more clinically relevant microorganisms.
We have extensive expertise in supporting clients through the all-important regulatory approval processes such as Medical Device Regulation (MDR), FDA 510(K) submissions, New Drug Applications (NDAs), Pre IND/IND applications and Biocidal Products Regulation (BPR).
From our UKAS-accredited laboratory in the UK our dedicated team of PhD scientists offer R+D projects, GLP compliant testing and ISO 17025 testing. In the US the Wyoming-based team specialise in customisable ex vivo models, including human skin, which can meaningfully predict clinical conditions without the added time and expense of potentially unnecessary in vivo testing.
Progressing microbiology for the greater good
Core to Perfectus Biomed is developing science which is practical, accessible, useful and based on real-world situations. We offer a number of innovative reliable and reproducible methods and models, testing to the very highest of standards. We have developed our models to help you de-risk future clinical development by simulating human substrates and in vivo conditions as closely as possible.
1. In vitro and ex vivo tissue models
Models which closely mimic the human skin are invaluable in studying it’s response to a variety of conditions. We offer a range of tissue models depending on the products being tested and client requirements:
Human Skin Model:
ELISAs or cytokine panel assays on incubated intact skin
Wounded skin model testing
Porcine Mucosal Model:
Used to mimic various infection states, from planktonic to biofilm, highly customisable
EpiSkin™ / Human Epidermis:
An in vitro reconstructed human epidermis from normal human keratinocytes
SkinEthic™ HOE/Oral Epithelium by EpiSkin™ :
An in vitro epithelial model composed of mucosal cells
Structurally similar to the mucosa of the oral cavity
A reconstituted model of the human airway with functional mucus production
Porcine Skin Model:
Using multiple size skin sections grown in transwells
Skin explants – used to test cellular toxicity and antimicrobial properties
Porcine Lung Model:
An ex vivo lung model to study bronchioles infected with Pseudomonas aeruginosa biofilm
Mimics human lung tissue especially useful in the study and treatment of chronic lung infection, such as patients with Cystic Fibrosis
2. Accredited Biofilm Methods
When microorganisms live beneath a biofilm, as is often the case in chronic wounds, they are significantly less susceptible to antimicrobial agents (and the host’s immune system). We offer a variety of accredited biofilm testing methods, such as the Single Tube Method, the Drip Flow Biofilm Reactor, the CDC Biofilm Reactor and the Minimum Biofilm Eradication Concentration (MBEC) and an ex vivo Porcine Lung Model to assess biofilm prevention and removal.
3. Viral Testing and COVID-19
Virucidal efficacy testing is important for assessing the activity of a variety of products against viruses. Perfectus Biomed also offer viral barrier testing for wound dressings and many other materials. Tests can be performed against human coronavirus 229E as a surrogate for COVID-19 or against vaccinia virus for a full enveloped virus, including Coronavirus, Influenza and HIV.
This is just a snapshot of what we can offer. Our talented and knowledgeable scientists are experienced in tailoring and customising testing, so get in touch today to find out how we can help you with your latest R&D projects email@example.com or call 01925 737237.
About Perfectus Biomed
Perfectus Biomed is a GLP-compliant and UKAS accredited ISO 17025 contract testing laboratory. We are leaders in providing standard and customised microbiology testing services to clients, specialising in biofilm testing and antimicrobial assays. Perfectus Biomed can support your outsourced microbiology and regulatory submissions.