From Flat to Functional: Recreating Human Microbial Environments with 3D Bioprinting

 

Image: Bioprinting of 3D Convoluted Renal Proximal Tubules on Perfusable Chips.Source: Homan K, Kolesky D, Skylar-Scott M, Herrmann J, Obuobi H, Moisan A, Lewis J (2016). "Bioprinting of 3D Convoluted Renal Proximal Tubules on Perfusable Chips". Scientific Reports. DOI:10.1038/srep34845

Not all microorganisms are harmful. In fact, our body naturally hosts tiny organisms like bacteria, viruses, and fungi that play essential roles in maintaining our health. Together, these helpful microbes make up what is known as the human microbiome. These beneficial bacteria and fungi aid in digestion, fight off harmful germs, and strengthen our immune system.

By Hannah Vargees 

Interestingly, these microbes don’t just interact with each other—they also interact closely with host tissues, immune cells, and environmental factors like pH levels, oxygen gradients, and nutrient availability within our body. Understanding these complex interactions is vital, especially when studying diseases or developing targeted therapies.

To study these interactions, scientists have traditionally relied on 2D cell cultures and animal models. But each of these approaches has its limitations.

First, let’s understand what 2D cell culture is. It involves growing human or animal cells on flat surfaces like plastic or glass dishes. These cells absorb nutrients from the surrounding media and spread out across the flat surface. While it’s a widely used and cost-effective technique, it doesn’t truly replicate how cells grow and behave in the human body. Flat growth alters cell behavior and signaling pathways, making it hard to recreate realistic tissue environments. Additionally, 2D cultures can’t support key features like biofilm formation or mucosal layering, both of which are essential for mimicking human microbial environments.

Next, we have animal models, which are commonly used to study diseases and drug responses. However, they come with their own challenges. There are species-level differences that are difficult to account for, and the immune responses in animals often differ from those in humans. This makes it challenging to translate findings directly into clinical outcomes, limiting their usefulness in drug development and microbiome studies.

This is where 3D bioprinting offers a promising solution. It allows scientists to precisely place cells in spatial arrangements that replicate tissue-like structures, enabling a more accurate and dynamic model of the human body. To create these structures, researchers use bioinks made from hydrogels like GelMA or alginate, which help simulate the natural tissue environment more effectively.

Hydrogels are particularly useful because they closely mimic the extracellular matrix (ECM) found in real tissues. They support cell growth, differentiation, and allow for the controlled diffusion of nutrients and oxygen. Moreover, they’re biocompatible and tunable, meaning they can be adjusted to match the mechanical and biochemical properties of specific tissues or organs.

In summary, while 2D cultures and animal models have laid the groundwork, 3D bioprinting is pushing the boundaries of how we study the microbiome and human health, offering more accurate, ethical, and customizable tools for modern research.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

What High-Quality Medical Software Consists Of

 

In the fast-paced world of healthcare, medical professionals rely on technology to deliver the best possible care to their patients. Health information technology has revolutionized the way medical facilities operate, streamlining processes and improving efficiency. Among these technological advancements, medical software plays a crucial role in helping healthcare facilities provide high-quality medical care to patients. In this article, we will discuss what high-quality medical software consists of.

By Hannah Whittenly

 

First and foremost, high-quality medical software such as Back Office Healthcare Operations Software, and others must be user-friendly and intuitive. Healthcare professionals have a demanding job, and anything that impedes their workflow can create unnecessary stress and frustration. Medical software must meet the needs of healthcare professionals by being easy to use and navigate. Designers of medical software must take user input into account during the development process to create software that meets the demands of healthcare professionals.

  

Another critical aspect of high-quality medical software is accuracy and reliability. Medical software must be reliable, consistent, and precise. Medical professionals rely on software for accurate information about patients, care plans, and medication management. Any errors or inconsistencies in the software could lead to disastrous outcomes, including misdiagnosis, treatment errors, and adverse drug reactions. For this reason, high-quality medical software must undergo thorough testing and quality assurance measures to ensure that it is reliable and accurate.

Furthermore, high-quality medical software should be secure and meet the requirements of HIPAA and other relevant regulations. Cybersecurity and data breaches are significant threats in the healthcare industry, and patients' information must be protected. Medical software must be designed with security in mind, including encryption and logging to ensure data privacy and prevent data breaches.

 

Interoperability is another critical aspect of high-quality medical software. The ability to share data between software applications and medical devices is crucial for seamless workflow integration and improved efficiency in patient care. Medical software developers must build systems that can communicate with other technologies, including electronic health records (EHRs) and medical devices, for effective patient management.

 

Finally, medical software must be scalable and adaptable to meet the changing needs of healthcare facilities. Improvements in medical technology and evolving regulatory requirements demand that medical software be scalable and adaptable. Medical professionals must have access to the latest tools and technologies that are flexible enough to adapt to emerging trends and future demands.

 

In conclusion, high-quality medical software must be reliable, accurate, secure, user-friendly, interoperable, and adaptable. The right medical software can help healthcare professionals deliver high-quality care to patients, streamline processes, and improve efficiency. The healthcare industry must continue to invest in innovative medical software solutions to meet the needs of an ever-changing healthcare landscape.

 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Revised: “Validation of Computerised Systems” Guideline

News from EDQM: Since the adoption of the first version of the “Validation of Computerised Systems” guideline in May 2009, most of the Network members have introduced computerised systems e.g. Laboratory Information Management Systems (LIMS) and electronic document management systems into their labs which have become commonly used working tools of the Network. For that reason and also based on experiences gained during Mutual Joint Audits, the guideline has been profoundly restructured and revised.

The scope for new core document states:

“This guideline defines basic principles for the validation of computerised systems used within Official Medicines Control Laboratories (OMCLs) and having impact on the quality of results, document control and data storage. The purpose of this validation is to guarantee confidence in the laboratory data captured, processed, reported or stored by computerised systems. A validated system ensures accurate results and reduces any risks to data integrity. This document applies to all types of computerised systems used in OMCLs. However, depending on their complexity, the extent of testing and documentation will differ. Computerised systems can be categorised into three types: exempted, simple and complex (see table I in section 3). This document describes a scalable validation approach for simple and complex computerised systems.”

The revised version is now organised in a core document and two annexes (instead of three annexes in the previous version). All three parts of the guideline will come into force on 1 August 2018.

For details, see: EDQM (https://www.edqm.eu/en/node/16211)

Posted by Dr. Tim Sandle

Computer Systems Validation

The MHRA are continuing their series on data integrity and computer systems validation. The latest blog post has some useful information (this time from Balall Naeem), such as:

If you are able to obtain validation documentation here are some suggestions on what you do next as a minimum:

1. If you receive a validation report check it, make sure it corresponds to the version of the software you are using. If it details the systems functionality then make sure all the functionality you are using is covered in the report.
2. If you receive a validation pack does it show the system to be successfully validated, i.e. has all the functionality you intend to use been tested and passed? Is it evident who the tester was and have they signed and dated everything correctly? Is it evident how test fails have been rectified? Is there anything that might cause you concern such as a missing follow-up test after a fail or undecipherable testing?
3. Are the dates sequential? Was all testing completed before the product was released? Were all the specification requirements and test scripts agreed and signed off before the build had been completed? Was the validation report issued prior to release?
4. If you have concerns can you address them? Are you able to self-validate or mitigate them in another way?
5. Do a formalised risk assessment, document your findings and record any mitigating action you are going to take.

For further details, see MHRA

Posted by Dr. Tim Sandle

Hewlett Packard apologizes after selling laptops for $2

Staff at Hewlett Packard in the U.K. were left embarrassed after accidentally selling laptops with a value of over $3,000 for around $2 (£1.58) via its website.

Hewlett Packard has issued an apology for taking its website down in the U.K. for the last weekend in July 2016. This was after an error on its website was detected. A mistake with product pricing allowed shoppers to purchase expensive laptops for less than $2 (£1.58). The laptops had a previous retail price of around $3,100 (£2,378.) Through a processing error the laptops were reduced in price and consumers were allowed to acquire the premium computers for next-to-nothing.

In a statement, the company said: "We apologize sincerely to impacted customers for any inconvenience caused" (as reported by the Daily Mirror.)

To add to the embarrassment, Hewlett Packard was alerted to the error not by the vigilance of its own staff or realizing that the takings were not adding up; instead the alert was sounded after those lucky enough to spot the error posted about their low-cost purchases on social media.

In the event, not many people were lucky since has cancelled all unprocessed on-line orders. Under British trading law, retailers are able to cancel online orders if they have made a "genuine and honest mistake on their part that you should have noticed." Hewlett Packard has said all buyers affected by the reversal will be refunded (in other words, they will get their $2 back and a feeling of disappointment.)

On realizing the error, Hewlett Packard took their website down on Saturday July 30, in order to stop any further sales and to make corrections. The website is now back up and running. The issue affected the ".co.uk" HP web-store only.



Posted by Dr. Tim Sandle