Producing heparin without the heartache

or without the Chinese deliberatley substtituing chemical contamination in lieu of actually producing the product they were paid to produce...but, hey, who's quiblling over details...

US researchers have developed a chemoenzymatic strategy to synthesise the anticoagulant drug heparin and avoid the contaminant that has killed more than 80 people.


The breakthrough was presented at the ACS (American Chemical Society) National Meeting and Exposition in Philadelphia, US, earlier this week and described how Escherichia coli (E. coli) bacteria could be harnessed to synthesise the widely-used anticoagulant that has global annual sales of around $4bn (€2.7bn).

Heparin is produced by extraction from pig intestines and contaminated batches of the drug have been linked by the US FDA (Food and Drug Administration) to more than 80 deaths and hundreds of allergic reactions among patients treated with the drug during heart surgery and kidney dialysis.

The contaminated heparin was traced by the FDA to various batches imported from small, family-run workshops in China which supply about 70 per cent of the world’s supply.

While regulators called for greater cooperation and joint inspections of overseas active pharmaceutical ingredient (API) manufacturing plants, Professor Robert Linhardt of the Rensselaer Polytechnic Institute, US, and Associate Professor Jian Liu of the University of North Carolina, US, to search for an alternative method of production.

Prof. Linhardt was part of the team that identified the suspected contaminant as a structurally similar carbohydrate called oversulfated chondroitin sulfate.

"When we found the contamination, it was another sign that the way we currently manufacture heparin is simply unsafe," said Prof. Linhardt.

Researchers have been trying for years to develop a synthetic production method for the drug, however the first total synthesis described in 2003 by researchers from the Massachusetts Institute of Technology (MIT), US, produced only minute batches at a time and could not be economically scaled-up for commercial production.

The synthesis developed by Prof. Linhardt’s team uses a patented biosynthesis that uses enzymes expressed in E. coli bacteria to replicate the normal biosynthesis of natural heparin.

While the team has only used the technique to create the drug on a laboratory scale, scaling the process up should prove no more difficult than scaling-up the production of any other biological drug.

The group plans to begin the necessary preclinical and clinical trials needed to bring the synthetic heparin to market. If successful, the new heparin could be on the market in two to five years.

link to full article

FDA seizes drugs worth $74,000

How come we can't get this level of enforcement on real drugs??...

The US Food and Drug Administration (FDA) has ordered the seizure of $74,000 worth of Xiadafil VIP tablets after SEI Pharmaceuticals refused to withdraw them from the market.

A formal request for the recall of the erectile dysfunction dietary supplement was issued by the FDA after it discovered batches contained an undeclared active pharmaceutical ingredient (API).

SEI refused to recall the products leading to the FDA enlisting US Marshals to seize the batches to prevent more illegal Xiadafil from being sold.

Margaret Glavin, associate commissioner of the FDA’s Office of Regulatory Affairs, said: “Today’s seizure action shows that the FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers.

“The FDA will not tolerate a company’s failure to take voluntary action to protect the public health after being given the opportunity by the FDA to do so.”

link to full article

Gene found for rare and deadly childhood cancer

News out of CHOP...

WASHINGTON (Reuters) - Researchers have found a gene that causes most inherited forms of neuroblastoma, a rare and deadly form of childhood cancer, and say the discovery points to new treatments.

Mutations in a gene called ALK were strongly linked to neuroblastoma, the researchers from the United States, Italy and Belgium reported on Sunday. They said several companies already are working on drugs that target this gene, which is also mutated in some cases of lung cancer and lymphoma.

"This discovery enables us to offer the first genetic tests to families affected by the inherited form of this disease," said Dr. Yael Mosse of The Children's Hospital of Philadelphia, who worked on the study.

"Furthermore, because there already are drugs in development that target the same gene in adult cancers, we can soon begin testing those drugs in children with neuroblastoma."

link to full article

Stem cell advance may help transfusion supplies

Don't tell Northfield or Biopure...

NEW YORK - Scientists say they've found an efficient way to make red blood cells from human embryonic stem cells, a possible step toward making transfusion supplies in the laboratory. The promise of a virtually limitless supply is tantalizing because of blood donor shortages and disappointments in creating blood substitutes.

Red blood cells are a key component of blood because they carry oxygen throughout the body.

Experts called the new work an advance, but cautioned that major questions had yet to be answered.

The research, published online Tuesday by the journal Blood, was reported by scientists at Advanced Cell Technology in Worcester, Mass., the University of Illinois at Chicago and the Mayo Clinic in Rochester, Minn.

link to full article

Budget Juggling...

Maybe everybody who lose's their job at the NIH...Slowdown In National Institutes of Health (NIH) Funding Creates 'Quiet Crisis'

Can get a job with the FDA...Agency To Add More Than 1,300 Scientists

Researchers Correct Decline In Organ Function Associated With Old Age

Hurry Up!!!

As people age, their cells become less efficient at getting rid of damaged protein — resulting in a buildup of toxic material that is especially pronounced in Alzheimer's, Parkinson's disease, and other neurodegenerative disorders.

Now, for the first time, scientists at the Albert Einstein College of Medicine of Yeshiva University have prevented this age-related decline in an entire organ — the liver — and shown that, as a result, the livers of older animals functioned as well as they did when the animals were much younger. Published in the online edition of Nature Medicine, these findings suggest that therapies for boosting protein clearance might help stave off some of the declines in function that accompany old age. The study's senior author was Dr. Ana Maria Cuervo, associate professor in the departments of developmental & molecular biology, medicine and anatomy & structural biology at Einstein.

link to full article

Heparin taint tied to deaths

FDA: 3 fatalities linked to material in Baxter product

The U.S. Food and Drug Administration, for the first time, has conclusively linked deaths of patients infused with the blood thinner heparin to a foreign substance found in specific lots of the drug made by Deerfield-based Baxter International Inc.

In an interview Tuesday with the Tribune, the FDA said it completed its review of 93 death reports related to heparin that the agency received from Jan. 1 to March 31, a period when there was a dramatic spike in potentially deadly allergic reactions from patients who had been injected with heparin. The popular blood thinner is used widely in large dosages, often before patients have dialysis or heart surgery.

Of 10 reports of death from severe shock known as anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for an animallike substance known as oversulfated chondroitin sulfate. Heparin lot numbers were not known for the other seven deaths from anaphylaxis or hypotension, so the FDA could not determine whether those 7 patients received heparin contaminated with the substance.

"We have what looks like a cause and effect in some patients," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an interview, referring to the three deaths linked to contaminated heparin. "We know that they got contaminated heparin, and they died subsequently. This is one of the final links in the chain."

link to full article

Good and Evil: A Cancer Vaccine from Tobacco Plants

Tobacco makes a comeback!!!

In the first human trial of its kind, a vaccine grown in genetically engineered tobacco plants has proved to be safe, paving the way to one day use it to help combat a potentially fatal form of non-Hodgkin's lymphoma.

Researchers report in the Proceedings of the National Academy of Sciences USA that the experimental vaccine triggered the immune systems of 11 of 16 volunteers (with so-called follicular B-cell lymphoma) to attack their tumors without any apparent dangerous side effects.

Some 18,000 Americans, typically between the ages of 60 and 65, are diagnosed annually with this incurable, slow-growing type of cancer. Study coauthor Ronald Levy, an oncologist at the Stanford University School of Medicine, says that physicians generally take their cues from the disease, waiting to see how fast it is moving—and treating it with toxic chemotherapy (sometimes with radiation) only if it becomes aggressive.

He says that if future trials are successful, the experimental vaccine, which can be made relatively quickly and cheaply, could become a short-term therapy administered immediately after diagnosis to try to keep tumors in check.

"This may not be a replacement for chemotherapies, but a supplement for them," Levy says. "A technology that is fast, like this one, is more amenable to a watchful waiting approach than a technology that is slow to produce."

link to full article

Senate Appropriations Committee Approves $2 Billion for FDA

Now they're gonna regulate the #@&?#!!! out of us...

The Senate Appropriations Committee unanimously passed an appropriations markup measure Thursday, providing the FDA with a $2.04 billion fiscal 2009 budget.

This amount is $324.6 million more than the agency initially received for fiscal 2008. The measure will have no number until it is introduced in the full Senate.


link to full article

FDA Moves Forward With Exempting Phase I Drugs From GMPs

So much for those bothersome regulations...

More than two years after withdrawing a final rule that would have exempted investigational drugs in Phase I testing from certain good manufacturing practice (GMP) regulations, the FDA is issuing a final rule to do just that.

The new rule, which amends the GMP regulation with the exact same language as the withdrawn rule, was published in Tuesday’s Federal Register. Slated to take effect Sept. 15, it will apply to small-molecule drugs and biologics, including vaccines and gene therapy products.

“FDA’s position is that the United States’ [GMP] regulations were written primarily to address commercial manufacturing and do not consider the differences between early clinical supply manufacture and commercial manufacture,” the agency says.

link to full article

Even India is slowing down!!!

Biotech growth slows for first time in 5 years

Bangalore: After five straight years of rapid expansion, India’s biotechnology industry slowed to 20% growth in the year to March, down from more than 30% in the previous years, largely due to a rising rupee and price pressures in the global market.

link to full article

NJ to lose more than 800 pharmaceutical jobs

New Jersey gets pounded!!!...

More than 800 pharmaceutical jobs leaving New Jersey as part of major restructuring

NEW YORK (Associated Press) - More than 800 pharmaceutical jobs will be leaving New Jersey starting in August.

Most of the job cuts and transfers are part of major previously announced restructurings at Johnson & Johnson and Schering-Plough Corp. This week, the companies specified how many of those jobs would be lost at New Jersey locations.

Schering-Plough, based in Kenilworth, is cutting 500 jobs. New Brunswick-based J&J is eliminating 22 jobs at its Ortho Biotech unit in Bridgewater, shifting another 260 to its Centocor unit in Horsham, Pa., and cutting another 267 Ortho Biotect jobs outside New Jersey.

link to full article

The Race to China

Interesting post from Pharmalot regarding Pharma's move to China...

I understand the drivers behind these types of efforts, something to spruce up yet another bland corporate report,...something for senior management to tout as "the strategy"...reducing the costs of an already ineffective R+D effort, etc, etc...

These drivers will have more and more companies jumping on the bandwagon...

How many of these companies are backing up these efforts with a robust plan for maintaining the quality of the products they intend to produce?...and yes, that includes research efforts...or are they just looking at the cost savings?...

Study finds long benefit in illegal mushroom drug

Maybe this accounts for all those nice people you meet...

NEW YORK - In 2002, at a Johns Hopkins University laboratory, a business consultant named Dede Osborn took a psychedelic drug as part of a research project.

She felt like she was taking off. She saw colors. Then it felt like her heart was ripping open.

But she called the experience joyful as well as painful, and says that it has helped her to this day.

"I feel more centered in who I am and what I'm doing," said Osborn, now 66, of Providence, R.I. "I don't seem to have those self-doubts like I used to have. I feel much more grounded (and feel that) we are all connected."

Scientists reported Tuesday that when they surveyed volunteers 14 months after they took the drug, most said they were still feeling and behaving better because of the experience.

link to full article

The Gates Foundation: Dissatisfied With Results?

An interesting post from In The Pipeline...regarding the Gates Foundation

I guess I always assumed Bill would be just as successful in medicine as his other endeavors...

Enjoy...

'Designer baby' to be free from breast cancer

I don't know what to think about this...let the hype begin...

A British woman has made history by conceiving the country's first "designer baby" guaranteed to be free from hereditary breast cancer.

Using controversial screening techniques, doctors rejected six embryos which tested positive for the cancer gene in favour of "healthy" ones to ensure the child would not contract the disease.

The 27-year-old, who wishes to remain anonymous, is now 14 weeks pregnant with her first child after she was implanted with two of the cleared embryos.

She chose to go through the procedure because her husband had tested positive for the gene and his grandmother, mother, sister and cousin had all battled breast cancer.

link to full article

The Fierce 15 is out!!!

Just in case there isn't enough risk in earning your paycheck in the BioPharm industry...

and you want to actually invest money in these companies...

maybe even you own money...

FierceBio's Fierce 15 is out...

enjoy...

Sanofi launches $6.25bn vaccine battle plan

Wasn't it just a few years ago that no one was in the vaccine business because you couldn't make any money at it?

Sanofi-Aventis is to invest $6.25bn into vaccine production between now and 2015 as the company attempts to keep pace with rising demand.

This sizeable investment is in addition to the $940m the company has pumped into its French vaccine facilities between 2005 and 2008.

The company expects global vaccine sales to double to $34bn by 2016 and is investing heavily in construction or expansion at 15 sites to meet demand.

Speaking at the inauguration of its new $156m vaccine plant at Val de Reuil, France, Wayne Pisano, president and CEO of Sanofi-Aventis' vaccine subsidiary Sanofi Pasteur, said: "Sanofi Pasteur's commitment to global health is exemplified by significant investments in vaccine production infrastructures. These efforts are aimed at meeting a world demand for vaccines expected to double by 2016.

"The new facility will provide high-end production work environment for dedicated people who produce vaccines for the world."

Construction of the 7,800 sq. m. facility began in 2006 and is due to be operational by the end of 2008. Once online the plant will be capable of filling 200m vials and syringes a year, doubling the current capacity of Sanofi's operations at Val de Reuil.

link to full article

Microbix Chinese vaccine plant boosts global capacity by 20%

Now all we need to do is make a product without contaminations...

Canada-based Microbix has pulled off a coup in sealing a deal with the Chinese government for construction of a facility that will increase the world's vaccine supply by 20 per cent.

Construction of the $198m plant is to be jointly funded by Microbix and the Hunan provincial government, with the site due to become operational in 2013.

A more unusual aspect of the deal will see Microbix construct a replica of the childhood home of Dr Norman Bethune, a Canadian physician who is revered in China for his medical work assisting Chinese communists in resisting the Japanese in the late 1930s.

William Gastle, CEO of Microbix, said: "We've been working for a number of years to bring our technology to market, so today we're delighted to be partnering with the Province of Hunan in building and ultimately operating the most modern and efficient flu vaccine manufacturing facility on the planet.

"This will make China a leader in the production of flu vaccines, and Virusmax the technology of choice in helping other manufacturers in other countries expand their capacity to meet the needs of their populations."

link to full article

News from BIO 2008

BIOTECH: Artificial embryonic cells fuel research 'explosion'

BIO 2008 website