Albumin: The Natural Choice for Your Medical Device30 Sep 2020
With the number of new medical devices being developed at an all-time high and commercial successes making global headline news, the industry is booming. But this promising growth comes with underlying challenges.
While the most well documented of these is minimizing costs, securing access to biocompatible, safe, compliant medical device coatings is becoming increasingly important.
Cutting-edge medical devices, such as oxygenators, stents, control release devices, diagnostic implants and surgical sealants, continue to make their way through the development pipeline, fueled by huge leaps in medical understanding, increasing government expenditures, and the rising number of COVID-19 cases.
Many of these innovative, life-saving devices and instruments are smaller and more compact than any of their predecessors, making the appropriate coating and the protection it offers critical.
Challenges in medical device coatings
Finding the right coating, which enhances the performance and maneuverability of the medical device and protects it from pathogenic attacks, is an integral part of the development and regulatory pathway.
The ideal product should be biocompatible and biostable, offer excellent lubricity and thermal stability, and moisture-, chemical- and dielectric-barrier protection. Stability and batch-to-batch consistency are also paramount considerations, owing to their impact on performance, efficacy, and safety.
The biocompatibility of coatings is crucial for developers building the next generation of advanced medical devices while avoiding the risk of toxicity or an immunological response. The natural properties of recombinant human albumins (rAlb) make them the natural choice for medical device coatings. As a naturally occurring protein, albumin is widely recognized as safe and, with it being ubiquitous throughout the body, is fully biocompatible. In addition, human- and animal-free recombinant versions reduce the risk of unexpected pathogens to zero.
rAlb, a multi-functional excipient with validated stabilization properties, can play a key role in ensuring consistency and maintaining the stability and efficacy of a medical device so that patients receive optimal treatment with maximum effect.
Gary Willingham, US Business Development Director, Albumedix explains:
“In Albumedix, over the last few years, we have seen an escalation in the number of customer enquiries within the medical device space, with many resulting in a successful use due to the benefits provided for the given challenges.
Indeed, one of our valued partners in the UK, Chalice Medical, is working around the clock to handle the huge surge in demand of their ECMO devices (oxygenators / life support machines) as a result of the COVID-19 pandemic. In response, Albumedix are doing all we can to prioritize their shipments and any others related to the outbreak of the virus.”
Nature’s own coating
Only a highly pure albumin, like Recombumin®, facilitates the full exploitation of albumin’s potential while eliminating variability and reducing risk. The animal- and human-free product offers excellent batch-to-batch consistency and security of supply, providing safety, efficacy, reliability, and regulatory peace of mind.
As a medical coating, Recombumin is:
- Biologically stable
- Chemically inert
- Solvent free
- USP-NF compliant
- Manufactured to GMP-grade
- Supported by comprehensive regulatory documentation
Albumin's Natural Surface Coating Ability
Coating creates a biological interface between the patient and the medical device, limiting exposure to the underlying materials, increasing safety and boosting performance.
Albumin can cover both hydrophobic and hydrophilic surfaces in nearly a single molecule layer, meaning even small amounts can effectively cover large surface areas. In fact, just 1-2 mg of Albumedix recombinant human albumin products can cover 1 m2 of surface consistently.
This makes Recombumin especially suited to the medical devices industry, as it minimizes the need for elaborate release procedures and product performance monitoring. Additionally, its recombinant nature means it is free of risk with respect to human-derived pathogens and viruses, further warranting its mark as a safe product without toxicity, degradation or compatibility issues.
For over 22 years, Albumedix has applied its medical coating experience and technology to support a range of medical device applications, including elastomeric seals, coating mandrels, pacemaker components, stents and drug release coatings.
Albumedix can support the registration of your medical device product by giving you access to our highly experienced regulatory support team. Our regulatory documentation can help alleviate the regulatory burden and satisfy requirements for regulators, by providing the appropriate supporting data and documentation. Furthermore, Recombumin is the only rAlb that is compliant with the USP-NF monograph for recombinant human albumin.
Working in a dedicated facility, we have GMP certification from the MHRA and been inspected by FDA and Health Canada in support of customer applications. We have DMFs in many regions including the US and can provide support in answering regulators’ questions in relation to the use of albumin. By providing these key resources and capabilities, Albumedix has played a vital role in helping medical device manufacturers throughout the world develop their advanced technologies.
Towards the Future of Medical Devices
As new devices continue to enter the market, our expertise and evidence will be instrumental in supporting the development of new combination drug/device products, particularly in the field of advance therapy combinations. Our many years of experience in cell and gene therapy can be applied to such combination products.
Rising occurrences of ischaemic heart disease, chronic obstructive pulmonary disease, and acute lower respiratory infections in children, owing to surging pollution levels, are being witnessed. This is anticipated to foster increasing demand for hydrophilic lubricious coatings in several cardiovascular and urology catheters, sheaths, and short-term implanted device as it induces biocompatibility.
Moreover, augmented demand for quality healthcare, increasing geriatric population, and growing need for early detection and non-invasive therapies are expected to propel the demand for medical devices, which, in turn, will foster the market growth over the coming years.
About Albumedix – Dedicated to Better Health
Albumedix is a science-driven, biotechnology company focused on enabling the creation of superior biopharmaceuticals utilizing our recombinant human albumin products. We believe in empowering excellence to enable advanced therapies and unstable drug candidates reach patients worldwide. We are proud to be recognized as the world leader in recombinant human albumin with products and technologies used in clinical and marketed drugs by pharmaceutical companies worldwide. We are headquartered in Nottingham, England with more than 100 people all committed to improving patient quality of life. We are just as passionate about albumin and albumin-enabled therapies today as we were when we started 30 years ago.
Albumedix have developed a portfolio of rAlb products collectively known as Recombumin®, manufactured from proprietary Saccharomyces yeast strains, at ICH Q7 cGMP standards. Recombumin Elite is used in the manufacture of therapeutic pharmaceuticals, medical devices and advanced therapies, as a medium constituent for stem cell culture, and as an ingredient in cell therapy cryopreservation and formulation media. Recombumin Elite is the second Albumedix product to have a DMF; Recombumin Prime has had a DMF filed with the FDA since 2003, in Canada, Australia and New Zealand since 2004 and China since 2019.