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DSM and Crucell Announce PER.C6® Technology M

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Grand Cru
0
quote:

lucas D schreef:

[quote=Dirk R. Wijnen]
DSM and Crucell Announce PER.C6® Technology Milestone

Leiden, The Netherlands/Parsippany, USA, 11 March 2008 - DSM Biologics, a business unit of DSM Pharmaceutical Products, and Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) announced today that another important milestone has been achieved with the PER.C6® technology platform for the production of monoclonal antibodies and recombinant proteins. Scientists working at PERCIVIA reached a record level titer of 15 g/L at harvest for an antibody product. PERCIVIA is the PER.C6® Development Center joint venture between DSM and Crucell, located in Cambridge, Massachusetts, USA.

Marco Cacciuttolo, CEO of PERCIVIA comments, "This high titer achievement for PER.C6®, the highest reported to date, marks a major event for the biopharmaceutical industry. It demonstrates the power and robustness of the PER.C6® manufacturing platform and it clearly shows that the PER.C6® manufacturing platform will have a major impact to the overall economics of manufacturing biopharmaceuticals. DSM and Crucell recognized the enormous potential of the PER.C6® technology when starting the PERCIVIA joint venture just over 1 year ago. The breakthrough results achieved in a single year reinforce the special properties and abilities of the PER.C6® manufacturing platform. Based on our scientific data today, we are confident that we will be able to drive productivity even further."

Marcel Lubben, VP of Marketing, Sales & Business Development at DSM Biologics added, "We are very enthusiastic about the new 15 g/L milestone for our licensees. The PER.C6® manufacturing platform has tremendous potential for the biotech industry to significantly reduce the cost-of-goods for monoclonal antibodies and recombinant proteins, resulting in more affordable therapeutic treatments for patients."

Martina Molsbergen, VP Business Development at Crucell, added "The PER.C6® platform can reduce the risk of supply limitations and potentially postpone major capital expenditure decision hurdles for drug development companies. The 15 g/L milestone is instrumental in the further market penetration of the PER.C6® technology."

[/quote]

Mooi bericht, dit kon weleens net het zetje zijn wat Crucell nodig had om het sentiment te doen omslaan, en zorgen voor een gestaag hoger sluitende koers.
Het zal me dan nu ook niet verwonderen als Crucell aan het eind van 2008 in het rijtje aandelen staat van de aandelen die het meest in koerswaarde gestegen zijn.

lucas D
heerlijk, een dagje gestegen en er komen weer mega dromen naar voren.
[verwijderd]
0
quote:

flosz schreef:

Els Brinkman uit maart 2007:

Therapeutic glycoproteins produced on PER.C6 by Els Brinkman, Crucell
March 29th 2007

PER.C6® Therapeutic glycoproteins
�� Impact of glycosylation
�� mAbs
�� EPO
�� FV-L/C

Human EPO expressed in PER.C6® cells
Summary
• Purified with mean sialic acid content up to 14.3
• Robust yield and quality
• Restricted heterogeneity in glycosylation
• Comparable clearance rates in rats as Eprex
�� slower clearance in rats with increasing sialic acid content
• Comparable activity as Eprex

www.brpl.nl/library/presentations/29-...

Waiting for Genentech to rear their head. Yes, with Novartis ready to produce a cutrate version of EPO, DNA can hire Crucell to undercut them and and still make a big profit...

Hello Crucell, 15 grams per liter...Screw you Novartis and Amgen, we'll sell for 10% below your cost and still make 400%.

Genentech takes 20% stake in Crucell and signs long term deal for Crucell to make EPO and other things..

Amgen is gonna be pissed, and Amgen was down today?

Things that make you go Hhhhmmmmm?

YeeeeeHawwwww!
flosz
0
quote:

ron banged schreef:

Things that make you go Hhhhmmmmm?
YeeeeeHawwwww!
"We know a song about that" ....

Zo raar...nog steeds zonder berichtgeving...nog nooit gezien.

www.youtube.com/watch?v=JxFH9KVDKKs

sambal
0
goede morgen flozz. geen bericht hoe laat de analisten bij eenkomst begint. beetje raar vind je niet?????
maxen
0
quote:

ron banged schreef:

...
YeeeeeHawwwww!
Dat is weer eens een andere afsluiting dan "Fire B."

Nu nog wachten op een post van onze andere momentum commentator in de trand van "als ... dan zijn de volgende koersdoelen 1x.xx en 2x.xx", "Crucell heeft zijn low gezet; loopt niet parallel met algehele Bear trend", "Welk Korea probleem?"
flosz
0
quote:

sambal schreef:

goede morgen flozz. geen bericht hoe laat de analisten bij eenkomst begint. beetje raar vind je niet?????
Idd. heeeeel raar....
Calling Oya.......
The Clash er dan ook nog maar bij.
www.youtube.com/watch?v=FiVvA9YQpiI
flosz
0
Hehe....

Investor and Analyst Day, London
Wednesday March 12, 2008



On Wednesday March 12th, 2008 Crucell will organize a day in London for investors and analysts, where company management will hold presentations on Crucell’s strategy, products & technologies as well as provide an update on various key programs in the company’s pipeline.



Link to the video webcast
(The drop-down menu under the video player allows you to switch between the presentations).



Link to the agenda


Presentation downloads:

--------------------------------------------------------------------------------

Ronald Brus, Chief Executive Officer (start 9.00 am)

Link to presentation slides

--------------------------------------------------------------------------------

Cees de Jong, Chief Operating Officer (start 9:30 am)

Link to presentation slides

--------------------------------------------------------------------------------

Bart Klein, EVP Intellectual Property & Legal (start 11:15 am)

Link to presentation slides

--------------------------------------------------------------------------------

Jaap Goudsmit, Chief Executive Officer (start 11.45 am)

Link to presentation slides

--------------------------------------------------------------------------------

John Lewis, Vice President Scientific Affairs (start 1.45 pm)

Link to presentation slides

--------------------------------------------------------------------------------

Maria Grazia Pau, Program Director (start 2.15 pm)

Link to presentation slides

--------------------------------------------------------------------------------

Lex Bakker, Program Director (start 2.45 pm)

Link to presentation slides

--------------------------------------------------------------------------------
www.crucell.com/page/downloads/Agenda...

www.thomson-webcast.net/uk/dispatchin...
maxen
0
www.crucell.com/page/downloads/Agenda...

Wednesday March 12, 2008
Four Seasons Hotel
46 Westferry Circus, Canary Wharf, London

8.30 am – 9.00 am Breakfast & Registration

9.00 am – 9.02 am Oya Yavuz
Welcome & Opening remarks

9.02 am – 9.30 am Ronald Brus
Mission & Strategy

9:30 am – 10.15 am Cees de Jong
Operational Excellence

10:15 am – 10:45 am Questions & Answers

10:45 am – 11.15 am Coffee Break

11:15 am – 11.45 am Bart Klein
Intellectual Property

11.45 am – 12.30 pm Jaap Goudsmit
Portfolio Review
Research Strategy & Product Development

12.30 pm – 12.45 pm Questions & Answers

12.45 pm – 1.45 pm Lunch

1.45 pm – 2.15 pm John Lewis
Technology Overview

2.15 pm – 2.45 pm Maria Grazia Pau
Adeno Vaccines, Malaria & Tuberculosis Programs

2.45 pm – 3.15 pm Lex Bakker
Rabies Monoclonal Antibody Cocktail

3.15 pm – 3.45 pm Questions & Answers

3.45 pm – 4.00 pm Closing Remarks
aossa
0
quote:

aossa schreef:

Aankondiging webcast op homepage van de website

Wednesday, March 12 at 9.00 PM (CET)

www.crucell.com
Aanvangsuur volgens webcast (slide): 9:00 GMT
dwz 1 uur verschoven nl. 10:00 onze tijd.

Op de homepage staat dan weer 9:00 PM (CET)

Wat een knoeiboel zeg ...
Oya gelieve dringend bijles(sen) te nemen !
(of laat het jou eens op een papiertje schrijven)

www.worldtimeserver.com/current_time_...
flosz
0
quote:

maxen schreef:

www.crucell.com/page/downloads/Agenda...

Wednesday March 12, 2008
Four Seasons Hotel
46 Westferry Circus, Canary Wharf, London

8.30 am – 9.00 am Breakfast & Registration

9.00 am – 9.02 am Oya Yavuz
Welcome & Opening remarks

9.02 am – 9.30 am Ronald Brus
Mission & Strategy

9:30 am – 10.15 am Cees de Jong
Operational Excellence

10:15 am – 10:45 am Questions & Answers

10:45 am – 11.15 am Coffee Break

11:15 am – 11.45 am Bart Klein
Intellectual Property

11.45 am – 12.30 pm Jaap Goudsmit
Portfolio Review
Research Strategy & Product Development

12.30 pm – 12.45 pm Questions & Answers

12.45 pm – 1.45 pm Lunch

1.45 pm – 2.15 pm John Lewis
Technology Overview

2.15 pm – 2.45 pm Maria Grazia Pau
Adeno Vaccines, Malaria & Tuberculosis Programs

2.45 pm – 3.15 pm Lex Bakker
Rabies Monoclonal Antibody Cocktail

3.15 pm – 3.45 pm Questions & Answers

3.45 pm – 4.00 pm Closing Remarks
En wie gaat dit doen…Jaap?:

13-02-2007
Protein Products: Blood-clotting Factor V and biosimilars: At the company's analyst day in November Crucell announced the development of blood-clotting Factor V. With an estimated market potential of over US$3 billion, Factor V is designed to treat bleeding in haemophiliacs and to treat other bleeding conditions. The company is also working on the production of improved versions of currently marketed protein products on its PER.C6® production technology.

*********************************************

12-02-2008
Blood Coagulation Factor VL/C: Conclusive proof of concept for this blood coagulation factor has not been established to date. Preclinical work on this program continues and we will provide a complete status update during the Analyst Day on March 12th, 2008 in London.
***********************************************

Q&A (27:50)
Tony Campbell (Knott Partners) -> 12 mrt…..with respect to new information on Factor V.

En dankzij de goede oren van Mr. Sponge:
Q&A 56:00
we will disclose more of those....... (antibodies)
phx.corporate-ir.net/phoenix.zhtml?p=...
********************
Misschien kan Cees de Jong "iets" vertellen over operational spoorlijntje?
(Light railway, a subway line extension and a transfer station between those two transit lines.)
aossa
0
quote:

aossa schreef:

Op de homepage staat dan weer 9:00 PM (CET)
Nu rechtgezet 10:00 AM (CET)
flosz
0
quote:

maxen schreef:

[quote=ron banged]
...
YeeeeeHawwwww!
[/quote]
Dat is weer eens een andere afsluiting dan "Fire B."

Nu nog wachten op een post van onze andere momentum commentator in de trand van "als ... dan zijn de volgende koersdoelen 1x.xx en 2x.xx", "Crucell heeft zijn low gezet; loopt niet parallel met algehele Bear trend", "Welk Korea probleem?"
sammie is zo gek nog niet imo!
Korea, factorV.....
flosz
0
BB, by aossa:

Crucell, DSM hit 15g/L milestone with PER.C6 technology

By Pete Mansell
18-Mar-2008 - Dutch biotech Crucell and its US partner DSM Biologics have achieved a record yield of 15 grams per litre with their PER.C6 cell line technology for the production of monoclonal antibodies and recombinant proteins.
The 15g/L titre (i.e., antibody concentration) was reached with an undisclosed antibody product by scientists working at the PERCIVA PER.C6 Development Center in Cambridge, US. This is the joint venture opened by Crucell and DSM Biologics in November 2006 as part of the PER.C6 collaboration they originally announced in December 2002.

Marco Cacciuttolo, chief executive officer of PERCIVA, said the new yield "marks a major event for the biopharmaceutical industry. It demonstrates the power and robustness of the PER.C6 manufacturing platform and it clearly shows that the PER.C6 manufacturing platform will have a major impact on the overall economics of manufacturing biopharmaceuticals."

Based on currently available scientific data, "we are confident that we will be able to drive productivity even further", Cacciuttolo added.

In February 2007 Crucell and DSM Pharmaceutical Products, the US-based contract manufacturer that is DSM Biologics' parent, announced that fermentation yields for monoclonal antibodies with the PER.C6 system had reached 10g/L. Last December DSM told Reuters yields were now up to 13g/L.

The joint venture partners had previously talked about ramping up to 20g/L by the end of 2007. But according to Barbara Mulder, director of corporate communications for Crucell, that was never an official target.

"We are very happy with the target we've reached," Mulder commented. As for the future, she declined to make any specific projections. However, he joint venture wanted to "fully use the capacity" of the PER.C6 technology and was working on improving the production platform, Mulder said

The PER.C6 system uses cell culture for the large-scale production of monoclonal antibodies (MAbs) and recombinant proteins. Its claimed strengths include an "excellent" safety profile, scalability, versatility and productivity under serum-free culture conditions.

The technology has the potential to reduce the start-up time for MAb or protein production from four weeks to two or three weeks, as well as offering a more predictable manufacturing process.

One of the benefits of higher yields is they allow manufacturers to shift to smaller, cheaper bioreactors. At the moment Crucell has no plans to scale down its own manufacturing using the PER.C6 system which, as Mulder pointed out, is all geared to development-stage products.

The same applies to the numerous biopharmaceutical licensees for the PER.C6 technology, including Sanofi-Aventis, Novartis, Wyeth and Merck & Co. It is very difficult to predict when any of these products may need to be manufactured in commercial-scale quantities, Mulder added.

What the Crucell-DSM joint venture is certain of is the substantial cost benefits of improving its PER.C6 yields, benefits it expects to be passed on to healthcare systems and patients. This is no small issue at a time when the high prices of novel biopharmaceuticals are under intense and critical scrutiny.

"The PER.C6 manufacturing platform has tremendous potential for the biotech industry to significantly reduce the cost of goods for monoclonal antibodies and recombinant proteins, resulting in more affordable therapeutic treatments for patients," commented Marcel Lubben, vice-president of marketing, sales and business development at DSM Biologics.

As an example, Mulder said, manufacturing antibodies against rabies might cost $1,000 per gram at a standard fermentation yield of 2-3 grams per litre. So using the PER.C6 system could bring the cost down to "only a couple of hundred US dollars or less".

According to Martina Molsbergen, Crucell's vice-president, business development, the technology can also "reduce the risk of supply limitations and potentially postpone major capital expenditure decision hurdles for drug development companies. The 15 g/L milestone is instrumental in the further market penetration of the PER.C6 technology."

The announcement did no harm to the joint-venture partners' share prices either, with DSM's closing around 4.5 per cent higher on 11 March and Crucell's shares up by about 6.5 per cent.

Crucell's share price took a jolt last September after the failure of Merck & Co's HIV vaccine candidate V520, which was produced using the PER.C6 technology.
www.in-pharmatechnologist.com/news/ng...
crucell.yourbb.nl/viewtopic.php?f=10&...
gogogoo
0
DSM Biologics and Upfront to Develop A Fully Disposable Chromatography System Optimized for High Yield Cell Line Production
COPENHAGEN, Denmark--(BUSINESS WIRE)--DSM Biologics, a business unit of DSM Pharmaceutical Products, and Upfront Chromatography A/S, a leading developer of customized industrial-scale separation services, today announced the collaboration between the two companies to optimize Upfront’s new, fully disposable chromatography system for use with DSM's proprietary manufacturing technology. The fully integrated disposable chromatography system will offer biopharmaceutical manufacturers significant efficiency and productivity benefits and is expected to be available for commercial use by the summer of 2008.

The combination of Upfront’s unique disposable chromatography system and DSM’s proprietary manufacturing technology will deliver a flexible, easy-to-use and high capacity bioprocessing platform that can be scaled from 0.1L to 100L for commercial manufacture and recovery of a range of biopharmaceuticals, including monoclonal antibodies.

Upfront’s proprietary cGMP-manufactured adsorbents, fluid processing platforms and ligand chemistries enable the production of a fully disposable chromatography system for bioprocessing: bringing together the excellent performance of affinity chromatography with the safety and cost-effectiveness of disposable components.

“Industrial chromatography systems were for many years thought to have no fully disposable solution.” commented Karen King, President, DSM Biologics. “Together with Upfront, we will be developing a combination of a unique disposable module and a high yield cell line that will for the first time enable the creation of a fully integrated, disposable biologic manufacturing process.”

Michael Bennett, CEO of Upfront said: “The biopharmaceutical industry has been seeking fully disposable chromatography systems over recent years. Our technology offers manufacturers all the productivity benefits they expect from industrial-scale chromatography systems and with DSM Biologics we have the perfect partner to drive this combination of disposable systems and high yield cell lines to market.”

About disposable chromatography

Upfront’s integrated disposable chromatography system is based on its proprietary Rhobust™ universal processing platform. Rhobust has been implemented in a range of industrial settings for commercial-scale recovery and purification of functional biomolecules, including monoclonal antibodies, direct from crude feedstocks. A key feature of Rhobust, and in particular the disposable system, is that it does not generate pressure during operation: enabling construction of cost-effective, single-use columns from plastic. The combined advantages of disposability and crude feedstock processing has delivered a single high-yielding system which eliminates the requirement for both cleaning validation and further clarification steps, such as filtration and centrifugation.

About Upfront Chromatography

Upfront Chromatography A/S develops and manufactures innovative products and technologies for extraction and recovery of biotherapeutics, functional biomolecules, macromolecular complexes, and even living cells, directly from bioreactors and industrial side-streams.

For customised separation services, Upfront offers access to its proprietary universal process platforms combined with extensive technical and regulatory support. From a feasibility study to commissioning of the final installation, Upfront works with its customers to develop adsorbents, ligand chemistry, columns and other hardware to optimise process performance.

Upfront’s research, development and ISO9001-compliant manufacturing facility is situated in Copenhagen, Denmark. Please visit: www.upfront-dk.com

About DSM Biologics

DSM Biologics, a business unit of DSM Pharmaceutical Products, is a global provider of manufacturing technology & services to the biopharmaceutical industry. In addition to offering world-class biopharmaceutical manufacturing services, DSM Biologics has co-exclusive rights, along with Dutch biotech company Crucell N.V., to license the high-producing PER.C6® human cell line as a production platform for recombinant proteins and monoclonal antibodies. The combination of the PER.C6® human cell line and DSM’s manufacturing services provides companies with a turn-key biologic manufacturing solution reducing cost, risk and time to market.

DSM – the Life Sciences and Materials Sciences Company

DSM creates innovative products and services in Life Sciences and Materials Sciences that contribute to the quality of life. DSM’s products and services are used globally in a wide range of markets and applications, supporting a healthier, more sustainable and more enjoyable way of life. End markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrics and electronics, life protection and housing. DSM has annual sales of almost EUR 8.8 billion and employs some 23,000 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam.

www.businesswire.com/portal/site/goog...
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