News: Drug Manufacturing Method Might Lead To Cheap Canine Cancer Drug

[DunesMom]

From yesterday's paper.

 

Notice the bold section near the end, about the researchers' desire to make the lymphoma and other drugs (cheaply) and "test market" them through sales to pet dogs -- they'd be human drugs that are already approved after testing them on dogs, but now manufactured in a vastly cheaper and different way, making them affordable for pets for the first time, according to the radio interview I heard this morning.

 

Might be worth sharing with vets or watching for. I know it won't help those already suffering , but it's a bright spot on the horizon. Let's hope a vet pharm signs on (and keeps the drugs affordable rather than pocketing the 90% cheaper manufacturing process).

 

 

San Diego Union Tribune 12/11/2012, Page A01


ALGAE CAN SLASH BIOTECH DRUG COSTS, PAPER SAYS


Manufacturing method would bemuch cheaper, says scientist at UCSD

BRADLEY J. FIKES • U-T

Expensive biotech drugs now made in high-tech manufacturing plants can be grown much more cheaply in genetically engineered algae, according to a paper published Monday in the prestigious Proceedings of the National Academy of Sciences.

Manufacturing costs can be reduced by 90 percent for these drugs, translating into half off their sales price, said Stephen Mayfield, a UC San Diego professor and senior author of the paper. The savings would provide financial relief to patients, health insurers and the federal government.

The technology could make obsolete the manufacturing plants that grow specialized mammal cells in carefully monitored and chemically controlled vats, plants that cost hundreds of millions to build.

SEE ALGAE • A9





UCSD’s Stephen Mayfield holds a colony of green algae specimens being cultured in his lab. JOHN GIBBINS • U-T

Article Continued Below
See ALGAE on Page A09

ALGAE • Dogswill be the first beneficiaries of the lower-cost drugs

FROM A1

In their place would stand greenhouses containing transparent plastic bags filled with algae, water and diluted fertilizer. In Mayfield’s vision, scientists will design drugs on a computer, get the appropriate DNA by mail order from a manufacturer, then slip the DNA into the algae of choice. Ramping up production would be simply a matter of adding more bags.

In the paper, Mayfield and colleagues demonstrated they could make an anti-cancer biotech drug identical to the original one now under development by a biotech company. Moreover, they tested it in mice and found that it had the same anti-cancer effect.

David Hansen, chief executive of San Diego-based MabVax, said the algae method of manufacturing is of interest if it works. The company is developing antibody-based vaccines.

“Any innovation in the area would be of benefit,” Hansen said.

The paper is the culmination of seven years of work by Mayfield, director of the San Diego Center for Algae Biotechnology, and his colleagues. They used a common algae called Chlamydomonas reinhardtii, regarded by algae biologists as a model research organism. It’s found in soil and fresh water.

The earliest biotech drugs, such as insulin, were made in genetically engineered bacteria. But more complicated medications developed later couldn’t be made in bacteria, so they are made in the cells of mammals, the most commonly used are derived from the ovaries of Chinese hamsters.

These Chinese hamster ovary, or CHO, cells are grown in temperature-controlled vats and provided with sugars and other nutrients. But bacteria also grow on the nutrients, Mayfield said, so keeping the vats sterile is a top concern.

Algae, by contrast, evolved in the open, under varying temperatures and conditions of acidity and alkalinity, Mayfield said. And the dilute fertilizer that nourishes the algae doesn’t spur bacterial growth the way sugars do.

“Algae require only trace minerals, fertilizer, and sunlight to be grown at scale, giving them the potential to produce recombinant proteins, including therapeutics, very inexpensively,” the paper stated.

Algae biologist Ursula Goodenough, a specialist in Chlamydomonas reinhardtii, said in an email she was impressed by the research.

“Wow — well this is a most exciting paper,” said Goodenough, a professor of biology at Washington University in St. Louis. More specifically, she said, the paper “greatly advances the potential use of algae to produce complex biological molecules for therapeutic and other uses.”

Mayfield and colleagues grew a two-part cancer drug in algae that cannot be completely made in CHO cells. It consists of a molecular missile called a monoclonal antibody designed to seek out specific cancer cells, attached to a cell-killing toxin “warhead.” Such drugs can’t be made in mammalian cells, because the toxin kills them, Mayfield said. The antibody part is grown in cells, extracted and purified, then chemically fused to the toxin, and the batch is once again purified.

But the toxin doesn’t kill the genetically engineered algae, so the entire drug can be made in one step, making the process far simpler and cheaper, Mayfield said.

The paper is titled “Production of unique immunotoxin cancer therapeutics in algal chloroplasts.” Its first author was Miller Tran, a postdoctoral student in Mayfield’s lab.

When Mayfield began his research, there was a lot of uncertainty about whether algae were up to the task of making complex proteins, he said. SoMayfield and colleagues started testing the limits of algae by producing progressively more complicated drugs in them.

In July, Mayfield’s group teamed with another from UC San Diego led by Joseph Vinetz to publish a paper about making a potential malaria vaccine in algae. The need for low manufacturing costs is critical to get mass malaria immunization in the countries that need it most, Mayfield said.

Dogs will be the first beneficiaries of these lower-cost drugs, Mayfield said.

“You have to go through canines anyway to prove they’re safe and effective,” Mayfield said of the drugs, which are typically tested in large animals before reaching humans. So instead of conducting clinical trials in animals as a milestone to human therapy, Mayfield is looking for a veterinary biotech company that would like to develop a treatment for animals directly from the research.

“You would never do this with traditional technologies,” Mayfield said. “You can make the best canine drug in the world, but if it’s too expensive, you’ll never sell it. What we can do is make one for canine lymphomas, make it cheap enough to sell, and that is the proof of concept we should make these things for humans.”

If dogs are able to get inexpensive treatments, the public will demand that they benefit from the same technology, Mayfield said.

bradley.fikes@utsandiego.com

(619) 293-1020 Twitter:@sandiegoscience





UC San Diego professor Stephen Mayfield (left) and Miller Tran, a postdoctoral student in his lab, teamed up to write a paper. JOHN GIBBINS • U-T