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COVID-19 – The Revolutionary Power of Bio Platforms Vaccines

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Moderna designed the final version of its vaccine within 48 hours of analyzing the virus genome on January 11, 2020. Phase 1 trials began 60 days later (in comparison, it took 20 months of conventional vaccine development for the SARS vaccine to reach Phase 1). This vaccine was approved by the FDA on December 17, 2020 (the 11 months until approval were spent with testing and regulatory formalities). In a similar vein, BioNTech was able to rapidly redirect its mRNA technology platform from cancer to COVID-19 in a matter of weeks.
And they did all that entirely on a computer using a digital copy of the virus (Chinese scientists had already sequenced its genome), without having access to the physical virus. Quite intriguingly, this means that a digital copy of the virus reached the U.S. and Europe before the actual virus emerged there.

How is that possible? Well, the answer lies in the revolutionary nature of new industrialized biotechnology platforms that exploit breakthroughs in biological engineering and artificial intelligence.
Rather than growing vaccines in bioreactors, a new generation of biotechnology companies designs instructions that the body then can use to produce its own therapy.
These novel vaccines exploit the process by which cells build proteins from the information encoded in a single-stranded molecule called messenger RNA (mRNA).

Once the COVID-19 vaccine enters a cell, the mRNA molecule tells it exactly how to build a piece of the SARS-CoV-2 virus. By exposing the body to this piece of virus induces its immune system to mount a response, thereby training the body to fight the real deal if it gets infected by SARS-CoV-2.

Using mRNA as a vaccine – or any mRNA medicine, for that matter – is a fundamentally different approach than conventional vaccines.
Traditional vaccines usually contain weakened or inactivated disease-causing organisms or pathogen proteins (antigens) to stimulate the body’s immune response. These conventional viral vaccines are manufactured in large bioreactors through a lengthy and cumbersome process – that can take many months – that involves numerous steps like preparation of the seed virus, fermentation, harvesting and purification. It also necessitates the handling of large volumes of live viruses grown in chicken eggs or mammalian cells.

Take the example of the annual ritual of developing a vaccine against seasonal flu, which commonly takes about half a year from identification of the prevailing influenza virus strain to producing a vaccine. The candidate flu vaccine virus is grown for about three weeks to produce a hybrid virus, which is less dangerous and better able to grow in chicken eggs. The hybrid virus is then injected into a lot of fertilized eggs and incubated for several days to make more copies. Then the fluid containing the virus is harvested from eggs, the vaccine viruses are killed, and the viral proteins are purified over several days.

mRNA vaccines eliminate pretty much all of this conventional manufacturing process.
In contrast, mRNA vaccines are based on just sets of instructions – like a software code – that direct cells in the body to make proteins to prevent or fight disease.

This makes mRNA vaccines very safe – they do not interact with the genome but just carry the information required for expression of the encoded protein.

The millions of proteins in our body are all made by piecing together different combinations of amino acids. And in this process mRNA plays a crucial role: It carries genetic code from DNA in the cell’s nucleus (composed of four different building blocks – the nucleotides adenine, cytosine, guanine, and thymine) to the cell’s protein-making machinery. These biological machines are called ribosomes and in some mammals every cell carries millions of them. Ribosomes read the mRNA and, based on the instructions (which contain hundreds or thousands of nucleotides linked in a unique order), synthesize a set of amino acids that are then folded into a specific protein.
In short, without mRNA, the body wouldn’t be able to use the genetic code contained in DNA. Proteins would never get made. Basically, your body wouldn’t function.

Building mRNA vaccines for COVID-19

Coronaviruses invade cells through surface molecules called spike proteins (named for the fact that they physically jut out from the rest of the virus), which take on different shapes in different coronaviruses. The SARS-CoV-2 specific spike protein is therefore a crucial antigen – i.e. a substance that induces the immune system to produce antibodies against it – that can be exploited for vaccine design.
And this is how an mRNA vaccine against COVID-19 works: Once the virus genome is sequenced – that means it is available as a digital copy – researchers can design an mRNA sequence that encodes the blueprint for the virus spike protein. Once tested for efficacy and safety in clinical trials, the mRNA molecule can then be synthesized on an industrial scale in robotic factories.
This mRNA molecule is wrapped with a lipid nanoparticle envelope, which protects it from degradation, and then directly delivered into cells. There, ribosomes get to work and read the mRNA as just any other blueprint – only this time they synthesize the spike protein. The finished spike proteins are then attached to the surface of cells where they are recognized by the immune system, eventually triggering the desired immune response against the virus.

In other words: Once you get your vaccine jab, the genetic instructions contained in the mRNA molecules are injected into the upper arm and the ribosomes in the muscle cells translate them to make a critical fragment of the viral protein directly inside your body. This ‘preview’ of what the real virus looks like gives the immune system time to design powerful antibodies that can neutralize the real virus if it ever gets in contact with it.
The protein production inside the muscle cells initiated by the injected mRNA injection reaches peak levels for 24 to 48 hours and can last for a few more days. Thereafter, the mRNA molecules get disassembled by the body.
The revolutionary impact of mRNA technology
mRNA COVID-19 vaccines have demonstrated in a very convincing way that biotechnologies have entered the industrial age. What we are seeing here is nothing less than the rise of bio platforms that give us the ability to engineer bits of biology, such as mRNA, to create programmable medicines and vaccines.

More generally, if it is indeed possible that mRNA can be used to make the full set of proteins in life, then it becomes possible to treat an incredible broad range of human diseases. This is at the core of the industrialized platforms that Moderna, BioNTech and others are building.
Essentially, an mRNA technology platform functions very much like an operating system on a computer. It is designed so that it can plug and play interchangeably with different programs. In this case, the ‘program’ or ‘app’ is the unique mRNA sequence that codes for a specific protein.
mRNA as the technological basis for therapeutics and vaccines is characterized by a great flexibility with respect to production and application. In essence, mRNA is an information-carrying molecule that can be industrialized – as opposed to traditional therapeutic molecules that have to be elaborately designed and synthesized from scratch for each application (i.e. medicine).
For starters, mRNA molecules are far simpler than proteins. mRNA is manufactured by chemical rather than biological synthesis, so it is much quicker than conventional vaccines to be redesigned, scaled up and mass-produced.
An excellent primer on the development of mRNA-vaccine technologies explains why: “Any protein can be encoded and expressed by mRNA, in principle enabling the development of prophylactic and therapeutic vaccines fighting diseases as diverse as infections and cancer as well as protein replacement therapies.”

And this is very the disruptive effect of the mRNA platform happens: If a therapy requires a certain protein to be encoded, only the sequence of the messenger RNA molecule needs to be changed, leaving its physico-chemical characteristics largely unaffected. In the above computer analogy, that is like writing a new piece of software that runs on the same operating system.

The disruptive force of emerging bio platforms

This means that diverse products can be manufactured using the same established production process – the same equipment, the same operators – without any adjustment and thereby saving massive amounts of time time and money compared with other vaccine or therapeutics platforms.
Having a library of genomes of potentially dangerous viruses, combined with the ability to quickly generate digital copies of emerging viruses thanks to powerful sequencing techniques, makes it possible to rapidly generate digital vaccine designs on a computer.
In the case of BioNTech and Moderna, these two companies spent a decade building their platforms to design and produce mRNA therapeutic candidates at massive scale, although originally targeted towards cancer medicines.
Moderna designed the final version of its vaccine within two days the first SARS-CoV-2 genome sequencing was made public – a matter of swapping out the ‘4 letters of life’ (the four nucleotides), according to CEO Stephane Bancel: “In 48 hours, we designed and locked down the entire chemical structure of the vaccine.”

This same dynamic allowed BioNTech to rapidly redirect its mRNA technology platform from cancer to COVID in a matter of weeks; the company estimates it can manufacture updated versions against emerging mutant strains in as little as six weeks.
What this all boils down to is that in the future every disease or infection can be described as a data sequence and every biological cure as an algorithm. As BioNTech states it: “Considering that all mRNA is generated with four different building blocks, but with unique sequence order, all therapeutic mRNAs have highly similar compositions, while having the capacity to encode a variety of different proteins. These characteristics allow for rapid development of mRNA therapeutics that are broadly applicable for treatment of many diseases, including cancer, infectious diseases and rare diseases.”

What are the limitations?

The limitations of mRNA technology are reached when the mechanism of a disease are not well understood, as for instance is the case with HIV, Alzheimer’s or many cancers.

However, as soon as you can pinpoint a specific protein, or several proteins in a certain ratio, as the root cause for a disease, then mRNA researchers can get to work on their computers and start designing the instructions for proteins that fix the problem.
Another complicating factor is to design the right delivery vehicle to get the mRNA into the targeted tissue and cells while evading the immune system. For vaccines it is relatively easy to inject it into muscle cells. It gets more difficult to get it to the brain, heart or the lungs.
Also, ribosomes have to think the mRNA was produced naturally, so they can accurately read the instructions to produce the right protein. Finally, the cells need to express enough of the protein to have the desired therapeutic effect.

The big picture

The emerging bio platforms will impact more than just industrialized vaccine development. They will transform all areas of biotechnology: areas like small molecule discovery, protein engineering, genome editing, gene delivery, and cell therapy.
By programming biology to allow a body to make its own medicine – programmable medicine – it will become possible to tailor diagnostics and therapies based on the genetic features of the disease-causing molecules. And because it is all based on the same underlying platform, it will be provided it in an easily reproducible, timely and cost-effective way.

Using mRNA as a platform technology – pretty much what Android or iOS are today for smartphones – will ultimately allow to create ‘apps’ for target groups such as allergy sufferers or smokers. It might even lead to bio agents that are synthesized for just a single individual, taking the term ‘individualized medicine’ to its logical conclusion.

Life with Covid-19 is Improving, but there are Six Things we still need to Practice

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We are now seven to eight months into the Covid 19 Pandemic here in the United States. I have now been through four pandemics. After my second pandemic, I developed a saying, the Center for Disease Control (CDC) actually stands for the Center of Dysfunction and Confusion.

I know it seems harsh, but it is not their fault. During these trying times at the start of a pandemic or epidemic, everyone is clamoring for information on coping with whatever bug is attacking humans or animals. The problem is science takes time. Data has to be compiled and researched, which leads to studies that have to be developed and conducted in a certain way, then those findings have to be analyzed to more refined studies to be conducted. Depending on their findings, they will then attempt to develop a scientific assumption that you and I can use to handle the disease facing humanity.

No matter what happens, there are six things you and I can do to reduce the likelihood of becoming infected. These six-steps are suitable to reduce the likelihood of catching a cold or flu too.

  • Washing your hands thoroughly and regularly. Well established studies have shown 80% of colds and flu transmit through hand contact, and 97% of adults do not wash their hands properly.
  • Clean and sanitize your surfaces. To clean, you need to use a product with a soap molecule, a product classified as a cleanser. Next, you need to use a disinfectant being both bactericidal and virucidal, using the proper dwell-time (wet contact time) on the surface before you wipe it off. (Do not use bleach), Why not bleach? Bleach is a strong oxidizer, not a disinfectant. Will it disinfect? Yes, when mixed with water at one part bleach to ten parts water, but no one tells you bleach damages every surface it touches, including your white clothes, and that it needs to be thoroughly rinsed after applying to any surface. Bleach will also begin to bleach out every surface where it is used. It takes the color out of Formica® (plastic laminate) and will bleach out almost every textile.)
  • Stay at home if you are sick. Every cold and flu will shed while you are feverish and symptomatic. Staying home will help keep others safe.
  • Avoid close contact. At home or work, we usually have close contact with family and co-workers. It’s this proximity, especially with longer contact times, that will spread the disease quickly.
  • Cover your mouth and nose while coughing or sneezing. As we’ve seen with Covid, coughing and sneezing spread the disease to other surfaces quickly. Depending on what virus or bacteria you’re shedding, it will be hard to contain since even speaking contains droplets we deposit everywhere.
  • Avoid wild or domestic animals. Why animals? Studies have shown that animals can carry and transmit diseases. Wild animals may be infected while domesticated animals like our dogs and cats and carry disease particles on their fur, and when we pet them, the disease can then transfer to us. (This is called a zoonotic transfer).

These six practices are a silver lining to the Covid Pandemic because these practices will give you and others healthier life.

Should you need help to clean and disinfect your business during this Covid Pandemic or any looming flu or cold event, we can offer a disinfection service that can short-circuit your place of business becoming a vector point for infection. Call Crime Scene cleaners of Kansas City 816-808-7642 Missouri or 913-808-7642 Kansas. You may find our website at www.crimescenecleanerskc.com

“No One Should Be Victimized Twice” – The Motto We Live By

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Many years ago now, people didn’t have companies who specialized in Trauma Remediation of structures. Families were left to beg, borrow, or steal anyone they could get to help clean up from suicide, homicide, or an unattended death scene. It didn’t matter to the families then who came out to help, they just couldn’t find it within themselves to enter those scenes and do what seemed an impossible task, as it would be for any of us.

That’s why companies like Crime Scene Cleaners KC exist. To provide a trained but detached resource who is properly trained, and yet has the compassion to give of themselves, in helping families and businesses recover from these losses. We called it bio-cleaning, bioremediation, bio-recovery, crime and trauma scene clean up, even forensic restoration but, what it really means to those who are in need of the service, is compassionate help.

I can’t image what it would take to walk into a room where my loved one died in traumatic ways and have the strength and fortitude to start and finish the task at hand and I’ve been doing this work for over 25 years. In the early days, as I look back through my mind’s eye and memories the work we did was so elementary to how we perform today. The processes have evolved, the chemicals have changed and this has now grown into a fulltime career for many people.

But the mission has ALWAYS been a constant.
“No One Should Be Victimized Twice.”

When our company grew large enough to start hiring and training technicians we found we have to hire certain kinds of people. This work is not for everyone. First of all they have to be mentally stable. Another is they have to show they have a servants heart, as we put it, someone who wants to serve people and help families who are hurting. Not all people who apply for this work can meet that criterion. Some who apply are folks who want to be involved in sensationalized work; they want to see a real crime scene up close and personal. Some people apply who want to satisfy some macabre itch; they want to see real blood and gore. Most of those we are able to weed out of our hiring process but what aren’t as easy is the “empathetic” person. You see there is a fine line between Sympathetic and Empathetic or Sympathy to Empathy.

A sympathetic person can show compassion for others going through stressful horrid times in their lives. They do this by sharing feelings of pity and compassion, but they are able to carry on their work in behalf of the hurting individual or family members. Whereby, an empathetic person is one who transfers someone’s feeling and emotion onto themselves; this state of mind cripples  that person’s ability to do the work as needed.

Here’s an example we’ve all seen. Picture a women is in heavy labor having a baby. She cries out in pain and her body writhes with pain. In the movies the husband is not by her side coaching her through this hard time but rather shown crumpled in a corner of the room holding his own stomach and perhaps even crying out in pain. In the movies this is funny and they call it incorrectly “sympathy pains,” when in fact, by real definition it should be called empathy pains.

What kind of husband then provides help to his wife having that baby? The Sympathetic husband who can mentally understand his wife is hurting but that he can help through his coaching and hand-holding or the Empathetic husband who is completely useless crumpled in the corner focusing totally on himself and his own supposed pain. Does this make sense to you?

It’s important we hire people who have a servant’s heart with the great capacity of being sympathetic as it is for us to reject the empathetic applicant. It is just as important to the empathetic applicant we reject them, as it is for them to find the right type of job. The reason being…an empathetic technician can end up with PTSD after months of struggling to get
through their work and this serves no one. If hired the empathetic technician would end up being hurt through the work. We’ve seen what PTSD can do to people over the years, many of the homeless veterans suffering from PTSD because it prevents them from properly engaging their loved ones and society in general.

So, through our hiring practices, we are also living up to our motto, “No one should be victimized
twice.”

BY DON M. MCNULTY © COPYRIGHT 2019

Winter is coming – Snow has already fallen in Nebraska and with it, comes Flu Season

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Flu season is upon us. Hopefully, you’ve heard the PSA’s (Public Safety Announcements) asking everyone
to get their flu vaccination and you’ve received your vaccination.

Some years back, I was so busy that every time I thought about getting my flu shot for that year, I was doing something else or the drug stores weren’t open. I did make it to my drugstore once but they were out of the vaccine and I never got to return.

-BAD MISTAKE.-

Come late January I remember thinking I may have dodged the bullet, but soon after I felt a cold coming on and then it turned bad.

Many a person mistook a bad cold as the flu but as I soon found out; if you really catch the flu, you’ll
know the difference. I literally saw my mortality; I was so ill and out of work for an entire week. If it hadn’t been for one of my managers handling the business I don’t know what I could have done.

Please do not put off getting the flu vaccine. For some, it could mean life or death.

Here are a few benefits of the flu vaccine.

No vaccine is 100% effective so if by chance you do get the flu the symptoms and duration of the flu will be much less.

The flu vaccine has been proven to lessen the chances of contracting the common cold, and like above if you do catch that cold it should be lesser than the cold without the vaccine.

Studies have shown there is a direct cost/benefit to companies who have paid to have their employees vaccinated, with a healthier workforce and families they go home to.

This has been an alert brought to you by Crime scene Cleaners of Kansas City, LLC. If you need your home or work areas cleaned and sanitized due to a flu outbreak, give us a phone call at 1-800-909-2939

 

By Don M. McNulty, MBT AT- OSHA, MTC ©COPYRIGHT 2018

Biohazard Management Has Many Faces

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Society has been cleaning up our dead since Cain and Able but in 1993 a small company in Blue Springs, MO started an industry by being the first company to dedicate these services of “Bio Cleaning” as they called it. So, for many years this work was designated by bio cleaning. Then another company started in 1995 and they called the industry Crime and Trauma Scene Cleanup and it is this phrase that has been the most prevalent. Shortly after in 1996 a company started on the East Coast of the United States and called the industry bio recovery and this too has had its following. In more recent years as the different factions came together biohazard management seemed to be the title most want to hang their shingle under for more than a decade but now another term has emerged, “Forensic Restoration.” This last term…although not predominant as yet, also has seen quite a bit of use. The many faces of the forensic restoration industry has seemingly been a mystery, as most industries usually end up with one title that most can point to after 25 years. The problem of having many names I believe stems from the many aspects of “Forensic Restoration Industry.” They at times touch law enforcement, the funeral industry, the structure restoration industry, infection control, and the general public as consumers, even terrorism from biological weapons. Further, they remediate from all sorts of trauma related crime incidents, such as, homicides, altercations, break-ins, and others such as, teargas, clandestine meth-lab, and drug houses. “Crime and trauma scene cleaners” are types of companies who remediate from trauma related suicides, unattended death scenes, or, home or business related accidents, they even touch the medical industry through their work sanitizing structures, such as, residents, commercial structures, educational facilities, correctional facilities, transportation, places of leisure, and the like from infections. These infections can be C. diff; MRSA, VRE, Norovirus (cruise ship virus) AIDS, HIV, Hepatitis and flu outbreaks and these mentioned are just the common infections they fight. This industry also does the bulk of hoarding syndrome cleanup. When Crime Scene Cleaners, LLC of Kansas City chose the name of their company all of this was still a burgeoning industry known by the name “Crime Scene Cleaners.” No matter what the name of the company is…all of the above work stated is what we do here at Crime Scene Cleaners of Kansas City. From time to time people ask us, how can we do this work each and every day? Our answer is
simple…Each and every day we go to work, is an opportunity to help a person, family and/or community. Our motto is “no one should be victimized twice.” If you need help with any of the services stated above or a job that no one wants to do, please call Crime Scene Cleaners, LLC of Kansas City at 1-800-909-2939, we always stand ready to help.

By Don M. McNulty, MBT AT- OSHA, MTC ©COPYRIGHT 2018

Biofilm the Beginning of ALL Soiling and Contamination

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Most people outside the professional cleaning and infection control industries and the adjunct industries haven’t heard the term “biofilm.” But, this film is the basis for all soiling and contamination within the living and work environment. Where does this biofilm come from? This is a question we at Crime Scene Cleaners KC have had to ask and learn the lessons in order to properly clean and sanitize the affected areas in our crime and trauma scene cleanup work or what we call forensic restoration.

Biofilm comes from two main sources, human activity and bacterial activity. Combined they form on a surface and continue to build into soiling you can see.

Here is how this works. Humans are fat. I’m not necessarily speaking to people who are overweight but rather the substance that makes us overweight, namely lipids and no matter how much you weigh, us all have lipids. Most of us know of lipo-suction where they literally suck the fat cells out of a person. Those lipids run through every part of the body. They are in your hair, skin, tears, nasal secretions, breath, saliva, blood and our waste. If you place your hand down on a surface and raise it up and look at the surface you will see an outline of your hand. You have just placed what most call hand-oil on to the surface. That hand-oil called, esters, a liquid form of lipids. That’s what you wash off your face and hair. We also place lipids on each surface with our breath. As we breathe, the air leaving our body is laden with lipids. Now that the lipids are on our surfaces and the moisture begins to evaporate the lipids become sticky. (Ever had blood between your fingers and as it dries you feel the stickiness?)

Being sticky on a molecular level it begins to attract micro-pollutants and bacteria floating through the air. Here is where the bacteria come into play. Once the bacteria is on the surface it begins to replicate producing a very sticky substance of a self-produced matrix of extracellular polymeric substances, meaning goo in laymen. A bacterium grows at an exponential rate. One bacterium on the surface continually divides to 2,097,152 in just seven hours. In twenty-four hours it divides to 4.7 sextillion, that’s 4.7 with 17 zeros behind it.

These two substances are continually growing through the human and bacterial activity attracting more and more micro-pollutants. The longer the biofilm lays on the surface it begins to harden into layers. Also, this bacteria laden biofilm is continually spread through our touching the surface and then touching yet another surface depositing the biofilm from one area to the next.

We start to see biofilm as our surfaces start to dull, or you see a dingy dark substance around cabinet handles, door knobs or light switches. I clean my kitchen counter tops at least twice a day…it takes just a few minutes. Yet, I’ve cleaned counter tops in a hoarder house roughly the same area and it has taken me several hours, why? The biofilm was deep and extremely hard and you have to work through those hardened layers. Here’s one more example; tooth plaque is biofilm on your teeth. The longer you wait between dental visits the harder the plaque is to remove and the more damage it generates.

The technicians at Crime Scene Cleaners, LLC in the Greater Kansas City Area are routinely trained in the science of cleaning and restoration. Our goal is to create sanitary surfaces within the built environment whether we are remediating are as affected by suicide, homicide, unattended death or performing infection control services in homes and businesses.

If you have an incident requiring a high level of expertise we have the training experience and equipment to properly perform the work; please call Crime Scene Cleaners at (816 or 913)-808-7642 or find us on the net at www.crimescenecleanerskc.com

 

By Don M. McNulty, MBT AT- OSHA, MTC ©COPYRIGHT 2018