DSM and Crucell Announce PER.C6® Technology M

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Dirk R. Wijnen
18
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."
Dirk R. Wijnen
0
Sir Piet
0
Ik denk dat weinig mensen de impact hiervan begrijpen. Is dat ik zo met crucell bezig ben anders was het voor mij ook alakadabra of zoiets.
bandit18
0
quote:

Sir Piet schreef:


Ik denk dat weinig mensen de impact hiervan begrijpen. Is dat ik zo met crucell bezig ben anders was het voor mij ook alakadabra of zoiets.


Wilt u die impact uitleggen dan voor de mensen die het niet begrijpen (zoals ik)
flosz
3
Op naar de 20 g/l…..

The current global market for proteins and monoclonal antibodies is worth $50-$60 billion and is estimated to grow to $200 billion by 2020, offering DSM and Crucell sales opportunities of more than $200 million annually at a 2 percent or more royalty basis.
In February DSM and Crucell announced they had succeeded in increasing fermentation yields in human cells to 10 grams per litre.
They also said that they expected yields could reach levels of 20 grams per litre. High cell densities are important as they enable high production yields.
Today we can say we have increased the yields to 13 (grams), which is an improvement of 30 percent compared to February," Sijbesma said, adding that it proves that 20 grams per litre could become reality.
"Fermentation yields are important for producing the cell line. Higher yields enable smaller and cheaper production units, which could mark a revolution for the (biotech) industry," he said.
"We now can start thinking of production in small units you can place on a table. Small units are cheap and can be disposed after use."
Current units are large and expensive and regulations by the food and drugs authorities require sterilisation of the units to prevent infections.
Crucell is the only company that has created a human cell line on this scale. The quality of human cells as a host for drugs and vaccines is much higher as they are more easily accepted by the human body.
Most other cell lines are produced in hamster cells and have fermentation yields of between 3-5 grams per litre.
crucell.yourbb.nl/viewtopic.php?f=10&...
****************************

Establishment of Higher Passage PER.C6 Cells for Adenovirus Manufacture.
pubs.acs.org/cgi-bin/sample.cgi/bipre...
**************************

Percy, Percy Six
A supa dupa biotechnological box of tricks

He's never alone he's got lots of mates
they say that he'll be big in the United States
he can cure the sick, he can cure the lame
pretty soon everybody is gonna know his name
so if you've got a sneeze that keeps coming back
or you're that latest victim of a virus attack

you need Percy, Percy Six, a 22nd century box of tricks
he'll fix you up if you're not at all well
he's got a billion brothers and he lives in a cell
He's gonna save the world one fine day...
Watch out everybody he's on his way!!!!
© ch

aossa
2
quote:

bandit18 schreef:

Wilt u die impact uitleggen dan voor de mensen die het niet begrijpen (zoals ik)


Menselijke eiwitten aanmaken:
* met nooit geziene opbrengst
* in kleinere installaties (wegwerpinstallaties)
* goedkoper en sneller produceren
* zuiverder eiwitten
* medicijnen die in de schuif leggen wegens te duur om te produceren worden nu weer mogelijk
* en_nog_zoveel_meer: oa. biosimilars voor wat nu nog uit (bloed)serum gemaakt dient te worden.

Morgen de R&D update, daar hoor je zeker meer.
[verwijderd]
0
quote:

flosz schreef:


Op naar de 20 g/l…..

Most other cell lines are produced in hamster cells and have fermentation yields of between 3-5 grams per litre.


Tja dit is weer crucell zoals ik het graag zie...zelfs met 10 g/l was crucell al superieur. Ik snap al dat ongeloof niet in crucell en de koersdaling hierop. Dit dient een ander doel waarschijnlijk om grof geld op crucell te verdienen. Een hoger doel dus niet ;)
oudje
0
[quote=flosz]
Op naar de 20 g/l…..

The current global market for proteins and monoclonal antibodies is worth $50-$60 billion and is estimated to grow to $200 billion by 2020, offering DSM and Crucell sales opportunities of more than $200 million annually at a 2 percent or more royalty basis.
In February DSM and Crucell announced they had succeeded in increasing fermentation yields in human cells to 10 grams per litre.
They also said that they expected yields could reach levels of 20 grams per litre. High cell densities are important as they enable high production yields.
Today we can say we have increased the yields to 13 (grams), which is an improvement of 30 percent compared to February," Sijbesma said, adding that it proves that 20 grams per litre could become reality.
"Fermentation yields are important for producing the cell line. Higher yields enable smaller and cheaper production units, which could mark a revolution for the (biotech) industry," he said.
"We now can start thinking of production in small units you can place on a table. Small units are cheap and can be disposed after use."
Current units are large and expensive and regulations by the food and drugs authorities require sterilisation of the units to prevent infections.
Crucell is the only company that has created a human cell line on this scale. The quality of human cells as a host for drugs and vaccines is much higher as they are more easily accepted by the human body.
Most other cell lines are produced in hamster cells and have fermentation yields of between 3-5 grams per litre.
crucell.yourbb.nl/viewtopic.php?f=10&...
****************************

Uiteraard kan ik niet zo goed zoeken als Flosz, maar ik heb onlangs gelezen op één van de fora, dat via hamstercellen 8 g/l bereikt is, maar ook dat is niet bedreigend.
tophound
0
quote:

Japies schreef:


Dit dient een ander doel waarschijnlijk om grof geld op crucell te verdienen


Neen: het doel is Van Herk Uitroken.
[verwijderd]
0
Ik neem aan dat crucell niet zo dom is om die 2% royaltie te handhaven. Immers als je 10 g/l doet stijgen naar 15 g/l dan mag de royalty ook wel met 50% omhoog. Immers door deze prestatie verdient de klant al geld, dan mag crucell die de technologie levert ook wel wat meer verdienen.

Bij CHO is de rek er overigens al lang uit, bij PerC6 nog niet. 20 g/l is haalbaar en misschien nog wel meer....
Dit zal allicht nu meer contrzcten gaan opleveren de komende maanden.
flosz
1
Sorry oudje, kom niet verder...: (zit nog wel een beetje rek in hoor japie,lol.)

STAR® technology supports high yield antibody & protein production. Using Crucell’s STAR® technology, high levels of protein can be generated. This has been demonstrated in several CHO derivatives for several proteins and different antibodies. Under standard non-optimized cell culture conditions using commercially available medium, specific productivity levels ranging between 25 and 70 pg /cell/day are easily achieved with screening of only up to 50 clones. Therefore Crucell’s STAR® technology is also ideal for stable bulk transfections to rapidly obtain adequate levels of protein for immunization, target discovery processes, protein characterization, or optimization and validation of downstream processes such as protein purification.

Zie Genzyme, pagina 29.
hugin.info/132631/R/1156099/223030.pdf
[verwijderd]
0
lucas D
1
quote:

Dirk R. Wijnen schreef:


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."



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
flosz
1
Ook interessant imo, met namen als John Aunins, Charles Goochee(van Maranga) en Weichang Zhou.(Zie pubmed publ.onder).

13 Apr 2008 Cell Culture Engineering XI
April 13 - 18, 2008
Hyatt Regency Coolum
Sunshine Coast, Queensland, Australia
DSM Presentation: "Monoclonal Antibody titers of 10 gram/liter and beyond; the Per.C6 cell line XD process"
www.dsm.com/en_US/html/dpp/events.htm
Met o.a. ook:

Efforts to Understand and Control Glycosylation in CHO Cell Culture Processes
Michael W. Laird, Genentech, USA
Investigation of Glycosylation Variability in a CHO Cell Culture Process
Suzanne Kuo, Genentech, USA
Rational Strategies for Improving Cell Culture Based Production of Cold-Adapted Influenza Vaccine (CIAV) Strains of Flumist®
Kunal Aggarwal, MedImmune, USA
Session IV: Cell Culture for Viral Production
Session Chairs: Amine Kamen (National Research Council, Canada) and
John Aunins (Merck, USA)
Session VIII: Cell Culture Process Development and Scale-up: Challenges and Case Studies
Session Chairs: Charles Goochee (J&J/GBSC, USA) and
Weichang Zhou (PDL BioPharma, USA)
Multiple Facets of Transient Expression Trials in HEK293 Cells: A Family Portrait
Sabine Geisse, Novartis, Switzerland
Framework Selection for Improved Production of Antibodies in CHO
Laura C. Simmons, Genentech, USA

www.engconfintl.org/8acpre.html

crucell.yourbb.nl/viewtopic.php?f=25&...
*****************************************

Maranga L, Goochee CF.
Metabolism of PER.C6 cells cultivated under fed-batch conditions at low glucose
and glutamine levels.
Biotechnol Bioeng. 2006 May 5;94(1):139-50.
PMID: 16523524
www.ncbi.nlm.nih.gov/sites/entrez?Db=...

Maranga L, Aunins JG, Zhou W.
Characterization of changes in PER.C6 cellular metabolism during growth and
propagation of a replication-deficient adenovirus vector.
Biotechnol Bioeng. 2005 Jun 5;90(5):645-55.
PMID: 15834950
www.ncbi.nlm.nih.gov/sites/entrez?Db=...

Xie L, Metallo C, Warren J, Pilbrough W, Peltier J, Zhong T, Pikus L, Yancy
A, Leung J, Aunins JG, Zhou W.
Large-scale propagation of a replication-defective adenovirus vector in
stirred-tank bioreactor PER.C6 cell culture under sparging conditions.
Biotechnol Bioeng. 2003 Jul 5;83(1):45-52.
PMID: 12740932
www.ncbi.nlm.nih.gov/sites/entrez?Db=...
flosz
0
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-...
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