Jul 9, 2021

The future of drug development: organ-on-chips

drugdevelopment
pharma
clinicaltrials
organonchips
4 min
The future of drug development: organ-on-chips
We ask Nortis CEO Thomas Neumann about organ-on-chips technology in drug development

Drug development can be a lengthy process, largely because of the inefficiency of testing on animals. However a new technology called "organ-on-chips" has emerged which is already transforming drug manufacturing. 

Rather than test on animals, a microdevice or "chip" is created lined with living cells from human organs and blood vessels. Researchers can then observe the effects of different drugs on these cells, which can more accurately reflect human responses. 

Biotechnology Nortis are one of the leaders in this field, so we asked CEO Thomas Neumann about the benefits and challenges of organ-on-chips (OOC), and what he thinks is next for drug development. 

What are the benefits of OOC in drug development compared to traditional methods?
Right now, drugs are typically tested using animal models, especially rodents, before progressing to clinical trials with human participants. Unfortunately, animal models often fail to accurately mimic the human condition, and a large portion of drugs that appear safe and effective in animals aren’t so in humans. The high attrition rate of clinical trials is a major contributor to the enormous costs of bringing new drugs to patients.

Nortis organ-on-chip technology has the potential to better predict whether a drug fails in clinical studies. This is exactly what AstraZeneca researchers have demonstrated in their recent publication. In their study, one of AZ’s drugs that had failed in clinical trials due to kidney toxicity was tested in the Nortis kidney chip. It turned out that the drug caused kidney toxicity in the Nortis kidney chip, in contrast to traditional cell culture and animal models, which did not show signs of kidney damage.

How widely adopted is it?
Organs-on-chips were considered an emerging technology a number of years ago, but at this point, the science is quite established. Many pharmaceutical companies and academic research institutions regularly utilise OOC technology to generate data that are more representative of tissue physiology and pathology – which is why the field is growing at a rapid pace.

Are there any challenges to using OOC? 
Researchers with experience in cell culture usually have the skills to grow the tissues in the chips until they are ready for experimentation. However, the process requires strict adherence to the cell culture protocols and can take up to several weeks.   

To eliminate the tissue culture step for the customer, Nortis began offering pre-seeded chips. In essence, they are chips that already have pre-established living tissues when they arrive in our customers’ labs. Pre-seeded chips bend the time and cost curve for our customers who need to work quickly and efficiently, and also drastically reduces user-caused failure rates.

What else is Nortis planning in this space?
Today, we are known for our leadership in applying OOC technology to assessing kidney function and response to kidney-toxic compounds, such as certain drugs and environmental toxins. Our goal is to continue supporting research in this space, scaling our technology to every kidney project that could benefit from more predictive, robust data.

Additionally, now that OOCs are an accepted and established technology, we’re venturing into the next generation of chips. As we continue to push the capabilities of this technology, our goal is to expand our tissue chips into models of important human diseases and make the technology compatible with lab automation and increased throughput. 

What predictions do you have for the future of drug development?
We believe that OOC technology will be increasingly adopted into the drug development process and will, in fact, change how drugs are developed. For example, researchers using OOCs as a tool for testing safety can identify drug candidates that would fail in clinical trials much earlier in the process.

In addition, we expect that OOCs will be used to re-assess shelved drug candidates that turned out toxic in animals  and never made it into clinical trials. FDA is already encouraging pharma companies to submit OOC data alongside animal data for submissions. In the future OOC data will not only be used to weed out such drug candidates that are likely to be unsafe in humans, it will also be used to create more confidence that those drug candidates that are moved into clinical trials are safe and efficacious.

Lastly, OOCs will be increasingly used in the early stages of drug discovery where it is important to understand disease mechanisms and tailor the appropriate cures.

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Jul 24, 2021

A guide to labelling compliance for medical devices

medicaldevices
Technology
healthcare
Compliance
Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.

Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.

But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it. 

On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.

Putting a plan in place

MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.

Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance.  They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.

When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.

Why labelling in the cloud offers a roadmap forward

Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.

The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.

When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.

A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.  

Future-proof technology

The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.

While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.

Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.

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