Real-life crab bleeders
Lately, bacteria and viruses are on the top of the worry list. The silent enemies are hiding in plain sight. Biomedical research is focused on irradiating human diseases. Often the disease is caused by microorganisms. Drug manufacturing is preoccupied to produce free from bacteria or other living microorganisms, totally clean vaccines, monoclonal antibodies, and medical equipment. Keeping it clean is not an easy task.
What it has to do with crabs or toxins?
Like many things in life, the toxins have the good and the bad, the yin and the yang.
One toxin is a celebrity. Botox, for example, is widely used in medicine and dermatology; a Clostridium botulinum bacteria produce it.
A good “toxic” example of another bacterial byproduct is toxoid, and scientists figured out how to create vaccines by inactivating toxins into toxoids.
Vaccination with the toxoids generates antibodies against the exotoxins. Biotechnology has created a toxin loaded smart bombs to attack cancer. A toxin is attached to an antibody, and the combo can deliver a precise punch to the cancer cell target. Approximately 60 pharmaceutical companies are developing new drugs that belong to Antibody-drug conjugates or ADCs. The success is tremendous and continuing, eight ADCs have received market approval for cancer of the blood, breast, and urinary tract.
Many other toxins are harmful to a living organism even after the toxin-releasing bacteria is eradicated. Staphylococcus aureus bacteria release toxin able to kill fast and furious, the condition called toxic shock syndrome. Toxins may linger inside medical equipment or hide in the raw vaccine ingredients.
Today with a unique challenge of strong worldwide demand for a quick COVID19 vaccine, drugmakers have an enormous responsibility for safety.
Every single drug approved nowadays is tested for purity. And crab’s blue blood is a gold standard for drug testing.
There are a lot of crabs on the line
A wild crab has something precious to offer. A horseshoe crab has been used for four decades for its unique blood; crabs bloodline has become a lifeline for humans. The blue-blooded crabs are an invaluable source of amebocytes that can fight pathogens hiding in the medical apparatus, ingredients needed to produce vaccines, and medical implants. Half a million crabs are harvested annually and made to bleed. Most of the crabs are released back to nature, but up to 15 %of crabs do not survive the blood donation. The faith of humanity relies on the crab’s population, at least until the synthetic analog to amebocytes is widely available and approved. Human-made crab blood is called recombinant Factor C (rFC). Last week the U.S. rejected the plans to put the synthetic crab blood test on an equal to industry-standard crab blood trials, at least temporarily. The hope of saving 100 000 carbs every year was briefly shattered. Europe the other hand is actively starting to recognize the synthetic crab blood as comparable, the U.S. still behind and needs more testing. Eli Lilly switched to artificial crab blood already with two drugs tested and approved under new guidelines.
Advocates of crabs are waring drugmakers to stop using horseshoe crab blood and switch to a synthetic alternative for safety tests, including the COVID-19 vaccine. Major testing laboratories are draining and bleeding their milky-blue blood for medical use to detect bacterial contamination in intravenous drugs or implants. And crabs eggs are a food supply essential for the survival of migratory birds.
“It is unfortunate that biomedical research still relies on the harvesting of a vulnerable wild animal population when there is a simple, effective, sustainable replacement,” said Ryan Phelan, an activist from California.
By estimates, many crabs sadly die during bleeding. They are returned to the ocean, up to a third of the blood is drained for biotechnology needs.
So far, only two drugs from both Eli Lily, have been approved after relying on rFC for final endotoxin tests.
Eli Lilly changed 90% of its safety testing to rFC. Wildlife advocates are pressuring more companies to follow.
Horseshoe crabs’ blood is unique has helped the species to survive for 450 million years. The blood is rich in copper, and it clots in the presence of the bacterial toxin. To be used as an essential raw material, blood is drained from live crabs. Crab bleeders in biotech was a $1 billion market pre COVID19. Watch out crabs; the demand is on the rise.
Human-made rFC from several biotech companies have emerged as an alternative, but big players (Charles River) has opposed rFC recognition. Eli Lilly recently stated that it had begun testing a COVID-19 antibody in humans with all the safety testing done with rFC. Senior Consultant Biologist at Eli Lilly Jay Bolden is a birdwatcher amateur. He was advocating the company to switch to the synthetic alternative. Bolden provided data to support the comparability of rFC with raw crab blood. “The data is out there, and it’s either not being looked at, or it’s being ignored,” he told newsmakers recently. “There’s no reason The United States Pharmacopeia (USP) should be asking for more data.”