Recombinant human collagens and gelatins
Based on expertise in collagen and the role of prolyl hydroxylase enzymes in the formation of collagen, FibroGen has developed the first known recombinant methodology for making fully synthetic collagens that are essentially identical to those found in nature. By making and testing different types of collagen that exist in nature, FibroGen scientists have demonstrated that recombinant type III collagen persists longer in tissue than any form of human or animal type I collagen. This unique characteristic of type III collagen serves as the basis for FibroGen's dermal filler product candidate for cosmetic applications.
Focused efforts over several years have also led to the development of a highly efficient production system employed by FibroGen to supply recombinant human collagens and gelatins (collagen fragments) as biomaterials for use in a variety of pharmaceutical and medical device applications. FibroGen produces recombinant human type III collagen (never before available in commercial quantities), recombinant human type I collagen, and distinct recombinant gelatin molecules optimized for specific applications. FibroGen's biomaterials address the needs of a wide range of customers in the pharmaceutical and medical device industries for safer, highly pure, and fully characterized alternatives to animal-sourced collagen and gelatin.
Friday, March 28, 2008
FDA moves to prevent Mad Cow Disease infecting Hemostat's and other Devices
The FDA is moving (some would say with glacier-like speed) to barr deadly prions from contaminating humans and animals via prohibiting the use of "high risk" animal products being used in drugs, biologics and medical devices (e.g. hemostat's) intended for humans as well as drugs intended for use in ruminant animals like cattle and sheep. Cattle can get mad cow disease, while sheep can get a similar disease known as scrapie.
The cattle materials prohibited in the proposed rule are those that pose the highest risk of containing infectious material and include:
the brain, skull, eyes and spinal cords from cattle 30 months and older;
the tonsils and a portion of the small intestines from all cattle regardless of their age or health;
any material from "downer" cattle--those that cannot walk;
any material from cattle not inspected and passed for human consumption;
fetal calf serum if appropriate procedures have not been followed to prevent its contamination with materials prohibited by this proposed rule;
tallow that contains more than 0.15 percent insoluble impurities if the tallow is derived from materials prohibited by this proposed rule and;
mechanically separated beef.
FULL TRANSCRIPT HERE
Collagen from Plants
CollPlant Ltd. is a biotechnology company specializing in the development and commercialization of safe, plant-derived collagen and protein-based biomaterials for the healthcare industry.
Collagen is one of the primary materials found in a variety of medical products including bone growth matrices, facial aesthetics, wound dressings, hemostats and sealants. During the last few years public awareness of the potential hazards of animal-derived collagen has begun to drive the healthcare industry to seek alternative sources for collagen.
CollPlant has developed a proprietary transgenic plant-based expression and production system for safe, high-quality, Type I recombinant human collagen. The Company's plant-derived collagen has an enhanced safety profile, as it is free of potential viral and other animal-derived hazards such as prions associated with Mad Cow Disease. In addition, CollPlant's transgenic plants are grown and cultivated within a completely sealed, environmentally-safe greenhouse.
In addition to its Type I collagen product, CollPlant is developing an extensive pipeline of additional high value, plant-derived protein polymers and composites with a variety of specialized characteristics tailored to specific markets such as orthopedics, aesthetic medicine, urinary incontinence, and wound healing.
CollPlant was founded in 2004 by a group of leading scientists, and is spearheaded today by experienced market-oriented executives from the global biotechnology arena.
Collagen is one of the primary materials found in a variety of medical products including bone growth matrices, facial aesthetics, wound dressings, hemostats and sealants. During the last few years public awareness of the potential hazards of animal-derived collagen has begun to drive the healthcare industry to seek alternative sources for collagen.
CollPlant has developed a proprietary transgenic plant-based expression and production system for safe, high-quality, Type I recombinant human collagen. The Company's plant-derived collagen has an enhanced safety profile, as it is free of potential viral and other animal-derived hazards such as prions associated with Mad Cow Disease. In addition, CollPlant's transgenic plants are grown and cultivated within a completely sealed, environmentally-safe greenhouse.
In addition to its Type I collagen product, CollPlant is developing an extensive pipeline of additional high value, plant-derived protein polymers and composites with a variety of specialized characteristics tailored to specific markets such as orthopedics, aesthetic medicine, urinary incontinence, and wound healing.
CollPlant was founded in 2004 by a group of leading scientists, and is spearheaded today by experienced market-oriented executives from the global biotechnology arena.
Thursday, March 27, 2008
Baxters Heparin worries cause concern for many Animal derived products
The US Food and Drug Administration (FDA) has received hundreds of reports of serious injuries and/or deaths in patients who have been administered heparin made by Baxter containing this contaminant - Baxter had sourced its API from SPL, who had sourced it from China. The lots in question were recalled in February.
SPL said it voluntarily initiated the nationwide withdrawal of the API as a precaution following the recent health scare involving Baxter's heparin, although as yet, no new adverse events related to this latest issue have been reported.
The voluntary recall also affects 23 finished product lots of heparin sodium in 5% dextrose and 0.9% sodium chloride injection solution manufactured and distributed by B. Braun Medical within the US and Canada. The company pulled these products from the market after it was notified by SPL of the API contaminant.
After weeks of investigations, the FDA has now identified the contaminant found in samples of Baxter's recalled heparin and confirmed that it is indeed linked to a Chinese manufacturing plant.
It has been revealed as oversulfated chondroitin sulphate, which is made from animal cartilage and is a cheaper alternative to raw heparin, which is normally derived from pig's intestines. It is not approved use in medicine, said Dr Janet Woodcock, director of the FDA Center for Drug Evaluation and Research.
"It doesn't appear to be a natural contaminant that got in there," said the agency, but a man-made compound that had been chemically modified to mimic raw heparin, the API used in a finished heparin product.
SPL supplies a refined form of the heparin API to Baxter and other firms from a plant it partly owns in China, called Changzhou SPL, along with a facility it owns in Wisconsin, US.
The contamination was present in the powdered form of raw heparin that was purchased by SPL's suppliers in China, according to Robert Rhoades, a pharmaceutical consultant for Becker & Associates, speaking on behalf of SPL.
SPL said it voluntarily initiated the nationwide withdrawal of the API as a precaution following the recent health scare involving Baxter's heparin, although as yet, no new adverse events related to this latest issue have been reported.
The voluntary recall also affects 23 finished product lots of heparin sodium in 5% dextrose and 0.9% sodium chloride injection solution manufactured and distributed by B. Braun Medical within the US and Canada. The company pulled these products from the market after it was notified by SPL of the API contaminant.
After weeks of investigations, the FDA has now identified the contaminant found in samples of Baxter's recalled heparin and confirmed that it is indeed linked to a Chinese manufacturing plant.
It has been revealed as oversulfated chondroitin sulphate, which is made from animal cartilage and is a cheaper alternative to raw heparin, which is normally derived from pig's intestines. It is not approved use in medicine, said Dr Janet Woodcock, director of the FDA Center for Drug Evaluation and Research.
"It doesn't appear to be a natural contaminant that got in there," said the agency, but a man-made compound that had been chemically modified to mimic raw heparin, the API used in a finished heparin product.
SPL supplies a refined form of the heparin API to Baxter and other firms from a plant it partly owns in China, called Changzhou SPL, along with a facility it owns in Wisconsin, US.
The contamination was present in the powdered form of raw heparin that was purchased by SPL's suppliers in China, according to Robert Rhoades, a pharmaceutical consultant for Becker & Associates, speaking on behalf of SPL.
PolyHeme
PolyHeme® is a human hemoglobin-based temporary oxygen-carrying red blood cell substitute in development for the treatment of life-threatening blood loss when an oxygen-carrying fluid is required and red blood cells are not available.
PolyHeme® is a solution of chemically modified human hemoglobin which simultaneously restores lost blood volume and hemoglobin levels and is designed for rapid, massive infusion.
PolyHeme’s characteristics include:
Simultaneously restores lost blood volume and hemoglobin levels
Universally compatible (does not require typing or cross-matching before infusion)
Immediately available
Has extended shelf life in excess of 12 months
Is manufactured from human red blood cells using steps to reduce the risk of viral transmission.
PolyHeme® is a solution of chemically modified human hemoglobin which simultaneously restores lost blood volume and hemoglobin levels and is designed for rapid, massive infusion.
PolyHeme’s characteristics include:
Simultaneously restores lost blood volume and hemoglobin levels
Universally compatible (does not require typing or cross-matching before infusion)
Immediately available
Has extended shelf life in excess of 12 months
Is manufactured from human red blood cells using steps to reduce the risk of viral transmission.
Tuesday, March 25, 2008
Insights, perspectives and inside data from the founder of MMD
Link for hemostasis marketresearch MedMarket Diligence
Friday, March 21, 2008
Thursday, March 20, 2008
Two-week-old blood no good for transfusions
Source: New Scientist
The common practice of storing blood for more than two weeks could be proving fatal for thousands of heart surgery patients, according to a major study.
Doctors at the Cleveland Clinic in Ohio have found that patients who receive blood that is more than 14 days old are nearly two-thirds more likely to die than those who get newer blood.
The survey of more than 9000 heart surgery patients also suggests that recipients of older blood are more at risk from blood poisoning and organ failure. The conclusion? "Blood should be classified as outdated earlier than current recommendations," says lead researcher Colleen Koch. Koch's team note that in the US the average age of transfused blood is more than two weeks - and that around half of all heart surgery patients receive blood transfusions.
New measures are urgently needed, say the researchers, to prevent unnecessary deaths among this large and vulnerable group of patients. Previous studies have suggested that transfusions increase the risk of death and serious complications. This latest study suggests the age of the blood used is a major factor.
Broken blood
On the basis of earlier laboratory studies, Koch speculates that, at the two-week stage, stored red blood cells begin to break down. This, she says, may make them more likely to block blood vessels while reducing their capacity to carry oxygen. Her team studied the medical records of patients who received major heart surgery at the Cleveland Clinic between June 1998 and January 2006.
A total of 2,872 patients received blood that had been stored for 14 days or less, and 3,130 patients received blood that was more than 14 days old. The mean storage age was 11 days for the newer blood and 20 days for the older blood. In-hospital mortality was significantly higher among those who received older blood: 2.8% compared to 1.7%.
The researchers also found that death rates a year on were nearly half as high again in the patients who had received older blood, compared to those who received newer blood. 11% of the patients who had received older blood had died a year later, compared to 7.4% of those who received newer blood. Both sets of patients received the same volume of blood.
"This research suggests that the longer transfused blood has been stored, the greater the risk of complications following cardiac surgery," says Peter Weissberg of the UK charity, the British Heart Foundation. He says that research last year indicated that, in many heart surgery patients, transfusions did more harm than good.
"Together, these studies suggest that only those heart patients whose lives are at serious risk without a transfusion should receive blood," Weissberg says.
"Further research is urgently needed to clarify the indications for transfusion and the effects of blood storage on outcome."
There are around 30,000 heart operations every year in the UK, and over 100,000 in the US.
Journal refs: New England Journal of Medicine, vol 358, p1229
Circulation, vol 116, p2544
The common practice of storing blood for more than two weeks could be proving fatal for thousands of heart surgery patients, according to a major study.
Doctors at the Cleveland Clinic in Ohio have found that patients who receive blood that is more than 14 days old are nearly two-thirds more likely to die than those who get newer blood.
The survey of more than 9000 heart surgery patients also suggests that recipients of older blood are more at risk from blood poisoning and organ failure. The conclusion? "Blood should be classified as outdated earlier than current recommendations," says lead researcher Colleen Koch. Koch's team note that in the US the average age of transfused blood is more than two weeks - and that around half of all heart surgery patients receive blood transfusions.
New measures are urgently needed, say the researchers, to prevent unnecessary deaths among this large and vulnerable group of patients. Previous studies have suggested that transfusions increase the risk of death and serious complications. This latest study suggests the age of the blood used is a major factor.
Broken blood
On the basis of earlier laboratory studies, Koch speculates that, at the two-week stage, stored red blood cells begin to break down. This, she says, may make them more likely to block blood vessels while reducing their capacity to carry oxygen. Her team studied the medical records of patients who received major heart surgery at the Cleveland Clinic between June 1998 and January 2006.
A total of 2,872 patients received blood that had been stored for 14 days or less, and 3,130 patients received blood that was more than 14 days old. The mean storage age was 11 days for the newer blood and 20 days for the older blood. In-hospital mortality was significantly higher among those who received older blood: 2.8% compared to 1.7%.
The researchers also found that death rates a year on were nearly half as high again in the patients who had received older blood, compared to those who received newer blood. 11% of the patients who had received older blood had died a year later, compared to 7.4% of those who received newer blood. Both sets of patients received the same volume of blood.
"This research suggests that the longer transfused blood has been stored, the greater the risk of complications following cardiac surgery," says Peter Weissberg of the UK charity, the British Heart Foundation. He says that research last year indicated that, in many heart surgery patients, transfusions did more harm than good.
"Together, these studies suggest that only those heart patients whose lives are at serious risk without a transfusion should receive blood," Weissberg says.
"Further research is urgently needed to clarify the indications for transfusion and the effects of blood storage on outcome."
There are around 30,000 heart operations every year in the UK, and over 100,000 in the US.
Journal refs: New England Journal of Medicine, vol 358, p1229
Circulation, vol 116, p2544
Tuesday, March 18, 2008
King Pharmaceuticals Acquires License from Gelita Medical to Hemostatic Products
King Pharmaceuticals, Inc. (NYSE:KG) and Gelita Medical BV announced today that the companies have entered into an exclusive license agreement relating to Gelita’s absorbable gelatin hemostatic products.
Pursuant to the agreement, King received an exclusive license to market, distribute and sell Gelita’s absorbable gelatin sponge in the U.S. Gelita will manufacture and supply the hemostatic product to King under the agreement. King’s THROMBIN-JMI® (thrombin, topical, bovine, USP), a topical active hemostatic agent, is often used by surgeons together with a variety of passive hemostatic agents, including absorbable gelatin sponges.
Brian A. Markison, President and Chief Executive Officer of King, stated, “The addition of Gelita’s absorbable gelatin hemostatic agents to our product line will further strengthen our expanding portfolio of hospital products. Importantly, this transaction further enhances the wide array of hemostatic options that our hospital sales team of over 110 professionals can offer physicians for the purpose of controlling bleeding during surgery.” Dr. Harrie van Baars, CEO of Gelita Medical, stated, “With King we have attracted an excellent and well focused marketing partner for our products in the U.S. market.”
King plans to begin marketing Gelita’s absorbable gelatin sponge in the U.S. after the product receives approval from the U.S. Food and Drug Administration for use during surgery. The license also provides King an exclusive option to acquire U.S. commercialization rights to any new hemostatic products developed by Gelita. The companies did not provide financial details relating to the transaction.
Dr. Harrie Van Baars of the Netherlands, CEO Gelita Medical, was previously CEO of Curamedical he also is also linked to company CircumventBV and the circumcision device the Smartklamp
Click Here for action Gelita is taking against Equicel
Link to FDA letter for Gelita approval Here
Pursuant to the agreement, King received an exclusive license to market, distribute and sell Gelita’s absorbable gelatin sponge in the U.S. Gelita will manufacture and supply the hemostatic product to King under the agreement. King’s THROMBIN-JMI® (thrombin, topical, bovine, USP), a topical active hemostatic agent, is often used by surgeons together with a variety of passive hemostatic agents, including absorbable gelatin sponges.
Brian A. Markison, President and Chief Executive Officer of King, stated, “The addition of Gelita’s absorbable gelatin hemostatic agents to our product line will further strengthen our expanding portfolio of hospital products. Importantly, this transaction further enhances the wide array of hemostatic options that our hospital sales team of over 110 professionals can offer physicians for the purpose of controlling bleeding during surgery.” Dr. Harrie van Baars, CEO of Gelita Medical, stated, “With King we have attracted an excellent and well focused marketing partner for our products in the U.S. market.”
King plans to begin marketing Gelita’s absorbable gelatin sponge in the U.S. after the product receives approval from the U.S. Food and Drug Administration for use during surgery. The license also provides King an exclusive option to acquire U.S. commercialization rights to any new hemostatic products developed by Gelita. The companies did not provide financial details relating to the transaction.
Dr. Harrie Van Baars of the Netherlands, CEO Gelita Medical, was previously CEO of Curamedical he also is also linked to company CircumventBV and the circumcision device the Smartklamp
Click Here for action Gelita is taking against Equicel
Link to FDA letter for Gelita approval Here
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