Beursonline.nl

flosz 13 januari 2009 10:09

13

ProFibrix Steps up Recombinant Fibrinogen Program With PER.C6(R) License From Crucell

Commercial License to Accelerate Development of New Hemostasis Breakthrough Products

LEIDEN, The Netherlands, January 13 /PRNewswire/ -- ProFibrix B.V., today announced that it has concluded a commercial license agreement with Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) for PER.C6(R), a unique human protein production platform. The PER.C6(R) platform allows ProFibrix to manufacture recombinant human fibrinogen at levels that support the development and commercial roll-out of new products. Fibrinogen is at the heart of all ProFibrix products and is an essential part of nature's own injury-repair mechanism. The company's lead product Fibrocaps(TM) is based on fibrinogen derived from human blood plasma and is a unique dry powder topical hemostat that stops acute and severe bleeding during surgery or after trauma injury. Initially recombinant fibrinogen will be developed for systemic applications in hemostasis and later on for the development of tissue repair products.

Jaap Koopman, Ph.D., Chief Executive Officer, said: "The PER.C6(R) license gives us access to a manufacturing platform that has already been successfully tested by ProFibrix for high expression of biologically active recombinant fibrinogen. Our Chief Technology Officer Dr. Bram Bout was one of the inventors of PER.C6(R) while at Crucell. His intimate knowledge of the platform in combination with our substantial in-house expertise on the biology of fibrinogen provides us with a strong competitive position in the hemostasis market."

Jan Ohrstrom, MD, Chief Operational Officer, said: "We believe recombinant fibrinogen has the potential to become a breakthrough product in hemostasis and tissue repair. We intend to develop a systemic hemostat product based on recombinant fibrinogen to treat or prevent bleeding in patients with low fibrinogen levels."

About ProFibrix

ProFibrix was founded in 2004 and is headquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA. The company leverages its expertise in fibrinogen technology to develop and market innovative products for the hemostasis and regenerative medicine markets. Human fibrinogen plays a pivotal role in blood clotting and tissue healing. ProFibrix is led by a team with extensive commercial, clinical and scientific experience in the hemostasis field. Fibrocaps, the company's lead product, is based on a mixture of fibrinogen and thrombin and is a unique dry powder topical tissue sealant that stops acute and severe bleeding after trauma injury or during surgery. Fibrocaps has major advantages over existing liquid tissue sealants: It is easier to prepare and use, is more stable and effective, and can be applied in various ways, including in sprays or bandages. To support the development of its pipeline, ProFibrix is establishing a recombinant fibrinogen production platform in human PER.C6(R) cells that is expected to go into GMP production in 2010.

SOURCE ProFibrix B.V.
www.profibrix.com/pages/profib_steps/...
****************************
Bram Bout, PhD
Chief Technology Officer
From 1993 – 2007 Dr. Bout was at Crucell, where he held several positions with increasing responsibilities. From 2000 – 2007 he was Vice President Protein Production. He also managed industrial liaison programs, including the collaboration with DSM on protein manufacturing. Before that, Dr. Bout was director of the adenovirus research group. One of the first achievements in this area was the development of the PER.C6® cell line in collaboration with Leiden University. Dr. Bout’s post-doctorate work was in gene therapy for Cystic Fibrosis. Dr. Bout gained his PhD on peroxisomal storage disorders at the Academic Medical Centre in Amsterdam and studied chemistry at the University of Amsterdam, The Netherlands.

flosz 13 januari 2009 10:19

5

Crucell Announces Research License Agreement with ProFibrix on STAR® Technology
Leiden, The Netherlands, 17 December 2007 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL, Swiss Exchange: CRX) today announced a non-exclusive STAR® research license agreement with ProFibrix BV. The license with The Netherlands based ProFibrix covers the production of specific forms of human fibrinogen, a protein involved in haemostasis (blood clotting) and tissue repair. Financial details of the agreement were not disclosed.

investors.crucell.com/C/132631/PR/200...
www.iex.nl/forum/topic.asp?forum=228&...

Recombinant Fibrinogen
The only currently available source of human fibrinogen is human donor blood. The amount of donated human plasma that is considered safe is in high demand, and the potential applications of fibrinogen are increasing. This could lead to a shortage of safe plasma derived fibrinogen in the future.

ProFibrix is committed to establishing a commercially feasible recombinant production platform for human fibrinogen that can be used for the development of new advanced products. Recombinant fibrinogen could have substantial safety advantages compared to fibrinogen purified from human donor blood and production can be scaled to meet any demand.

ProFibrix has recently established proof of concept of recombinant production of functional human fibrinogen in mammalian cell culture systems and is currently optimizing the expression required for a commercial manufacturing platform.

The recombinant fibrinogen platform provides ProFibrix with a unique position in the hemostasis and tissue repair market. Initially recombinant fibrinogen would be developed for use as systemic therapy in patients with inadequate levels of circulating functional fibrinogen.

Fibrocaps
ProFibrix' dry powder fibrin sealant
ProFibrix’s primary focus at the moment is on developing Fibrocaps – a new tissue sealant that stops acute and severe bleeding, after trauma injury, for example, or during surgery. Fibrocaps, a mixture of fibrinogen and thrombin, is a unique dry powder formulation that has major advantages over existing liquid tissue sealants: It is easier to prepare and use, is more stable and effective, and can be applied in various ways, including in sprays or bandages.
The current market for surgical application alone is estimated at $ 300 - 400 million per year, and this is expected to double in the next 3-5 years. Because of its unique properties, new markets for Fibrocaps may also be found in emergency settings outside the hospital, such as in ambulances, on battlefields and in the home.
The advantages of Fibrocaps are:
• Ease of preparation and application (particularly on large areas).
• Enhanced and reproducible efficacy due to improved mixing and homogeneity
• Stored as a ready-for-use fibrinogen /thrombin blend at ambient temperatures
• Increased viral safety profile.
• Utility in different presentation formats (e.g. bandages)
8,5 million euro for phase II development
The product has been tested in animal models of liver and spleen surgery and traumatic injury. GMP manufacturing for Fibrocaps is in development and Pharse I/II testing is expected to start by the end of 2008. In march 2007, ProFibrix raised 8,5 million euro funding which is expected to allow for the complete phase II testing of Fibrocaps. Phase III testing is expected to be comple by the beginning of 2010.

[verwijderd] 13 januari 2009 10:25

0

Het zijn er dus twee tegelijkertijd.
Één voor Per C6 en een voor *Star*.

maxen 13 januari 2009 10:27

1

In een jaar een research STAR licensie EN een commerciele Per.C6 licentie. Daar worden bouten met koppen geslagen bij ProFibrix.
Zouden ze nu dan de eersten worden die STAR op Per.C6 (i.p.v. CHO) gaan toepassen?

[verwijderd] 13 januari 2009 10:27

0

goed lezen w
(:->D)

flosz 13 januari 2009 10:31

2

quote:
maxen schreef:
In een jaar een research STAR licensie EN een commerciele Per.C6 licentie. Daar worden bouten met koppen geslagen bij ProFibrix.
Zouden ze nu dan de eersten worden die STAR op Per.C6 (i.p.v. CHO) gaan toepassen?

Haha, mooi die bouten met koppen.
STAR en PER.C6, was ook mijn eerste indruk.....Bram kan het weten.....kijk dit is imo pas spannend. Ik hoop dat we het gaan zien in 2010.(Met dank aan Dr.acula).

Huppeldepepup 13 januari 2009 10:42

0

Valt me op dat dit hele bericht op de site van Crucell niet te vinden is. Zou de afdeling communicatie het soms ergens anders erg druk mee hebben?

Hans Igor 13 januari 2009 10:46

0

quote:
Huppeldepepup schreef:
Valt me op dat dit hele bericht op de site van Crucell niet te vinden is. Zou de afdeling communicatie het soms ergens anders erg druk mee hebben?

Site ligt er even uit, omdat ze die aan het aanpassen zijn, blijkbaar. Komt er meer nieuws?
ING-beleggingen site ligt er ook uit.
(heeft niks met elkaar te maken, maar voor mij wel. Ik wil een order terugtrekken en dat lukt op dit moment niet Ka Uw Thee)

Huppeldepepup 13 januari 2009 10:48

1

quote:
Hans Igor schreef:
Ik wil een order terugtrekken en dat lukt op dit moment niet Ka Uw Thee)

Kwaliteit Uitermate Teleurstellend.

Hans Igor 13 januari 2009 10:49

0

quote:
Huppeldepepup schreef:
[quote=Hans Igor]
Ik wil een order terugtrekken en dat lukt op dit moment niet Ka Uw Thee)
[/quote]

Kwaliteit Uitermate Teleurstellend.

:-))) die is mooier!

harvester 13 januari 2009 13:17

0

Geen bericht PerC6 licentie - Zou de afdeling communicatie het soms ergens anders erg druk mee hebben? >> zou mij niets verbazen.

Ik had maandag al een algemene trading update verwacht.

aossa 13 januari 2009 13:46

0

Bewijs geleverd: personeel van Crucell rendeert elders beter ;-)

[verwijderd] 18 juni 2009 14:20

1

ProFibrix Initiates Phase II Clinical Trial of its Lead Topical Hemostat Product Fibrocaps(TM)

SEATTLE, Washington, and LEIDEN, The Netherlands, June 18 /PRNewswire/ -- ProFibrix B.V. today announced the start of the company's Phase II clinical trial for Fibrocaps(TM), the company's lead topical Hemostat product, with the successful treatment of the first patients for mild to moderate bleeding during liver surgery. ProFibrix expects to complete the study before the end of 2009.

Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant that rapidly stops bleeding after or during surgery. Fibrocaps has major advantages over existing liquid tissue sealants: it is ready for immediate use, is stable at room temperature, highly effective and fast acting.

ProFibrix expects to submit an Investigational New Drug Application (IND) for Fibrocaps to the U.S. Food and Drug Administration in the first half of 2010, and conduct a combined phase II/III pivotal study in various surgical indications.

Jaap Koopman, PhD, Chief Executive Officer, said: "The successful treatment of the first patients with our lead product Fibrocaps is an important milestone for the company. With focus and dedication we have made enormous progress over the past two years, and we are on track to bring Fibrocaps to the point of market approval."

www.redorbit.com/news/health/1707628/...

[verwijderd] 26 augustus 2009 08:33

0

Press Release
ProFibrix raises US $11 million (EUR 8 million) in series B financing

Jaap Koopman, PhD, Chief Executive Officer, said: “We are very pleased to welcome Gilde Healthcare to our investor base and we appreciate the ongoing support and expertise that our investors can offer to our experienced team as we continue the development of ProFibrix. The proceeds of the financing will be applied to the ongoing clinical development of our lead product FibrocapsTM, and to the preclinical development of our pipeline products.”

Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant that rapidly stops bleeding after or during surgery. Fibrocaps has major advantages over existing liquid tissue sealants: it is ready for immediate use, is stable at room temperature, highly effective and fast acting. Fibrocaps is currently in a Phase II clinical trial in the Netherlands with results expected end of 2009.

ProFibrix expects to submit an Investigational New Drug Application (IND) for Fibrocaps to the U.S. Food and Drug Administration in the first half of 2010, and to conduct a combined phase II/III pivotal study in various surgical indications.
www.profibrix.com/pages/press_release...

flosz 11 januari 2010 07:50

5

Even "op z'n plek".
To support the development of its pipeline, ProFibrix is establishing a recombinant fibrinogen production platform in human PER.C6(R) cells that is expected to go into GMP production in 2010.
*********************
Help for the Haemostasis Market
Jaap Koopman and Jan Ohrstrom at Profibrix examine how haemostats based on fibrin
are able to harness the natural blood clotting system to treat and prevent excessive bleeding
BLEEDING IS AN UNMET MEDICAL NEED
In developed countries, over 200,000 people bleed to death every
year, and in developing countries, this number is estimated to be
over 10 times higher. In the majority of these cases, bleeding is
the result of traumatic injuries and people often die before or
during transportation to appropriate hospital care. Additionally,
approximately five million people worldwide are hospitalised
because of severe bleeding and even within a hospital setting,
severe bleeding often presents a challenging situation to the
emergency medical professionals.
Apart from traumatic injuries, uncontrolled bleeding that requires
medical intervention also occurs in a variety of surgical settings
and is a factor that can negatively affect the outcome of surgery.
One of the challenges in treating bleeding is that it occurs in
many different forms, ranging from diffuse, to oozing from soft
tissues like the liver and spleen, to high pressure bleeding from
arterial injuries. The extent of haemorrhage is a function of the
degree of vascular disruption, blood pressure at the site of injury,
the clotting potential of the blood of the patient and the time from
injury to treatment.
………..
www.profibrix.com/filebin/pdf/EBR_Hae...

ProFibrix obtains government loan of up to EUR 5 million (~ US$7.4 million) to support clinical development of its lead hemostasis product Fibrocaps™
Leiden, The Netherlands and Seattle, WA, January 7, 2010 - ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced that SenterNovem, an agency of the Dutch Ministry of Economic Affairs, has granted the company a loan under its new Innovation Credit scheme of potentially up to EUR 5 million to finance the further clinical development of its unique new hemostat Fibrocaps™.

The loan consists of an initial commitment of EUR 2.75 million, with the possibility to call on an additional EUR 2.25 million when and if certain development milestones are met.

Jaap Koopman, PhD, Chief Executive Officer of ProFibrix said: “On the back of our recent successful B round in which we raised EUR 8 million (~ US $11 million), we are very pleased to further solidify the financial basis of ProFibrix. Loans under this special scheme are awarded to innovative projects with a strong commercial potential. This loan will be instrumental in financing the Phase II and III development of our lead product Fibrocaps.”

Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant that rapidly stops bleeding after or during surgery. Fibrocaps has major advantages over existing liquid tissue sealants: it is ready for immediate use, is stable at room temperature, highly effective and fast acting. Fibrocaps is currently in a Phase II clinical trial in the Netherlands with results expected early in 2010.

ProFibrix expects to submit an Investigational New Drug Application (IND) for Fibrocaps to the U.S. Food and Drug Administration in the first half of 2010, and to conduct a combined phase II/III pivotal study in various surgical indications.

ProFibrix will present at the Biotech Showcase, which takes place in conjunction with the JP Morgan Healthcare Conference in San Francisco, on Tuesday, January 12, 2010 at 8:40 a.m. in the “Regimental” room at the Marines' Memorial Club & Hotel, 609 Sutter Street, San Francisco.
www.profibrix.com/pages/profibrix_obt...
***********
Ter verduidelijking:
The PER.C6® platform allows ProFibrix to manufacture recombinant human fibrinogen at levels that support the development and commercial roll-out of new products. Fibrinogen is at the heart of all ProFibrix products and is an essential part of nature’s own injury–repair mechanism. The company’s lead product FibrocapsTM is based on fibrinogen derived from human blood plasma and is a unique dry powder topical hemostat that stops acute and severe bleeding during surgery or after trauma injury. Initially recombinant fibrinogen will be developed for systemic applications in hemostasis and later on for the development of tissue repair products.
-----------------------
STAR® research license agreement with ProFibrix BV. The license with The Netherlands based ProFibrix covers the production of specific forms of human fibrinogen, a protein involved in haemostasis (blood clotting) and tissue repair.
**************************************
To support the development of its pipeline, ProFibrix is establishing a recombinant fibrinogen production platform in human PER.C6(R) cells that is expected to go into GMP production in 2010.
*********************************
Recombinant Fibrinogen
The only currently available source of human fibrinogen is plasma from human donor blood. The amount of donated human plasma considered safe is in high demand, and the potential applications of fibrinogen are increasing. Experts believe that this could lead to a shortage of safe plasma-derived fibrinogen in the future.

ProFibrix is committed to establishing a versatile and commercially feasible recombinant production platform for human fibrinogen to enable the development of new, advanced products. Recombinant fibrinogen is believed to have substantial safety advantages over fibrinogen purified from human donor blood, while the ProFibrix platform is also designed to allow production to be easily scalable to meet any demand.

****ProFibrix has already established that recombinant human fibrinogen production in PER.C6® cells is cost-effective. In collaboration with a large-scale cGMP manufacturer, ProFibrix is currently in the process of expanding the production of recombinant fibrinogen to industrial volumes.****

The recombinant fibrinogen platform provides ProFibrix with a unique position in the hemostasis and tissue repair market. The first indication for recombinant fibrinogen ProFibrix is aiming for is its use as systemic therapy in patients with inadequate levels of circulating functional fibrinogen.
www.profibrix.com/pages/recombinant_f...

Fibrocaps Manufacturing
The main active components of Fibrocaps™, human thrombin and fibrinogen, are derived from human blood plasma collected in the United States, and which has been approved for human use.

During the production of Fibrocaps at the licensed manufacturing site in the UK, fibrinogen and thrombin are stabilized and separately spray-dried to produce soluble free-flowing microparticles. Subsequently, the microparticles are blended in a specific ratio to form a single ready-to-use dry powder fibrin sealant that can be stored at room temperature.

The Fibrocaps powder is applied to the wound site using a proprietary spray device.
www.profibrix.com/pages/manufacturing...
www.investorvillage.com/smbd.asp?mb=2...

[verwijderd] 14 januari 2010 16:58

0

(WO/2010/004004) RECOMBINANT FIBRINOGEN

Publication Date: 14.01.2010

Applicants: PROFIBRIX BV [--/NL]; Zernikedreef 9 NL-2333 CK Leiden (NL) (All Except US).
BOUT, Abraham [NL/NL]; (NL) (US Only).
GRIMBERGEN, Joseph [NL/NL]; (NL) (US Only).
KOOPMAN, Jacob [NL/NL]; (NL) (US Only).
Inventors: BOUT, Abraham; (NL).
GRIMBERGEN, Joseph; (NL).

Polymerisation of recombinant PER.C6 fibrinogen in plasma was equal to plasma and CHO-derived fibrinogen.

www.wipo.int/

harrysnel 18 juni 2010 09:49

1

ProFibrix and CSL Behring Enter into Fibrinogen and Thrombin Supply Agreement
Leiden, The Netherlands and Seattle, WA, June 17, 2010

ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced that it has entered into an agreement with CSL Behring for the clinical and commercial supply of plasma-based fibrinogen and thrombin, for the manufacturing of Fibrocaps™. CSL Behring is a leader in the plasma protein therapeutics industry and a subsidiary of CSL Limited (ASX: CSL), a global biopharmaceutical company headquartered in Melbourne, Australia.

Jaap Koopman, CEO of ProFibrix said: “We are extremely pleased with the supply agreement with CSL Behring. CSL Behring is one of the acknowledged global leaders in the plasma protein therapeutic industry. Importantly, the agreement will enable us to use CSL Behring’s fibrinogen and thrombin, approved in markets around the world, as active components in our lead product Fibrocaps. This will offer us a tremendous advantage with regulatory authorities when seeking approval for Fibrocaps.”

About Fibrocaps
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant in development to stop bleeding after or during surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, is stable at room temperature, and has shown to be safe and efficacious in the first Phase II study conducted in EU. ProFibrix is starting a global Phase II study in the summer of 2010.

About ProFibrix
ProFibrix (www.ProFibrix.com) was founded in 2004 and is headquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA, USA. The company leverages its expertise in fibrinogen technology to develop and market innovative products for the hemostasis and regenerative medicine markets. Human fibrinogen plays a pivotal role in blood clotting and tissue healing. ProFibrix is led by a team with extensive commercial, clinical and scientific experience in the hemostasis field.

About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide. CSL Behring therapies are indicated for the treatment of coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, inherited respiratory disease and hereditary angioedema. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in newborns. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (ASX: CSL), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.

www.profibrix.com/pages/profibrix_and...

[verwijderd] 18 juni 2010 10:05

0

quote:
harrysnel schreef:
ProFibrix and CSL Behring Enter into Fibrinogen and Thrombin Supply Agreement
Leiden, The Netherlands and Seattle, WA, June 17, 2010

ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced that it has entered into an agreement with CSL Behring for the clinical and commercial supply of plasma-based fibrinogen and thrombin, for the manufacturing of Fibrocaps™. CSL Behring is a leader in the plasma protein therapeutics industry and a subsidiary of CSL Limited (ASX: CSL), a global biopharmaceutical company headquartered in Melbourne, Australia.

Jaap Koopman, CEO of ProFibrix said: “We are extremely pleased with the supply agreement with CSL Behring. CSL Behring is one of the acknowledged global leaders in the plasma protein therapeutic industry. Importantly, the agreement will enable us to use CSL Behring’s fibrinogen and thrombin, approved in markets around the world, as active components in our lead product Fibrocaps. This will offer us a tremendous advantage with regulatory authorities when seeking approval for Fibrocaps.”

About Fibrocaps
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant in development to stop bleeding after or during surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, is stable at room temperature, and has shown to be safe and efficacious in the first Phase II study conducted in EU. ProFibrix is starting a global Phase II study in the summer of 2010.

About ProFibrix
ProFibrix (www.ProFibrix.com) was founded in 2004 and is headquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA, USA. The company leverages its expertise in fibrinogen technology to develop and market innovative products for the hemostasis and regenerative medicine markets. Human fibrinogen plays a pivotal role in blood clotting and tissue healing. ProFibrix is led by a team with extensive commercial, clinical and scientific experience in the hemostasis field.

About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide. CSL Behring therapies are indicated for the treatment of coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, inherited respiratory disease and hereditary angioedema. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in newborns. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (ASX: CSL), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.

www.profibrix.com/pages/profibrix_and...

Ik lees dit als "exit PER.C6", met als ondertoon "PER.C6 is maar lastig tijdens het goedkeuringsproces". Lezen anderen dit ook?

maxen 18 juni 2010 10:23

1

quote:
xynix schreef:
....
Ik lees dit als "exit PER.C6", met als ondertoon "PER.C6 is maar lastig tijdens het goedkeuringsproces". Lezen anderen dit ook?
[/quote]
In ieder geval voor de korte termijn geen Per.C6 in fibrocaps, maar dat was volgens mij al langer duidelijk.
Onduidelijk is of men voor lange termijn ook door blijft gaan met blood-derived fibrinogen, of daarvoor kiest voor Per.C6-based fibrinogen.

De opmerking
[quote=Jaap Koopman, CEO of ProFibrix said] “We are extremely pleased with the supply agreement with CSL Behring. CSL Behring is one of the acknowledged global leaders in the plasma protein therapeutic industry. Importantly, the agreement will enable us to use CSL Behring’s fibrinogen and thrombin, approved in markets around the world, as active components in our lead product Fibrocaps. This will offer us a tremendous advantage with regulatory authorities when seeking approval for Fibrocaps.”
[/quote]
zou inderdaad best kunnen slaan op lang goedkeuringsproces voor Per.C6. Hoeft niet perse het eind van Per.C6 te betekenen, WEL dat ze nu sneller met een product op de markt kunnen komen.

Al met al is de toekomst voor Per.C6-based fibrinogen wel onzekerder geworden.
[quote=Profibrix]
Recombinant Fibrinogen
The only currently available source of human fibrinogen is plasma from human donor blood. The amount of donated human plasma considered safe is in high demand, and the potential applications of fibrinogen are increasing. Experts believe that this could lead to a shortage of safe plasma-derived fibrinogen in the future.
...
ProFibrix has already established that recombinant human fibrinogen production in PER.C6® cells is cost-effective. In collaboration with a large-scale cGMP manufacturer, ProFibrix is currently in the process of expanding the production of recombinant fibrinogen to industrial volumes.

[verwijderd] 18 juni 2010 10:42

0

Maxen: AB-tje voor een goed, zakelijk commentaar. Ik lees jouw commentaren zo veel liever dan die onnodig denigrerende opmerkingen die normaal volgen op zo'n vraag van mij.

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