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portefeuille (99.60)

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June 12, 2009 – Comments (11)

A small update on influenza vaccine production. As I mentioned in comment #5 here (link 3 from that comment is no longer working. It led to a pdf-document by Novartis (NVS) on their ("egg-free") influenza vaccine production) chicken eggs are not necessary for the production of influenza vaccines.

Now the update:

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ZURICH (Reuters) - Novartis AG has produced a first batch of a vaccine to fight the H1N1 flu outbreak, will start clinical trials in July and expects to be able to ramp up manufacture rapidly.

The first results achieved with H1N1 wild type strain showed that it was quicker to make the vaccine through cell-based production compared to egg-based manufacturing, the Swiss drugmaker said in a statement Friday.

"Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine, weeks ahead of expectations," it said, adding it expects to get a license in the autumn.

...

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(from here)

Also have a look at their web site: http://www.novartis-vaccines.com ...

 

11 Comments – Post Your Own

#1) On June 12, 2009 at 7:27 AM, portefeuille (99.60) wrote:

(link 3 from that comment is no longer working. It led to a pdf-document by Novartis (NVS) on their ("egg-free") influenza vaccine production)

Well, by virtue of my dislike for deleting stuff here is the text of that document:

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Cell Culture-Derived Influenza Vaccine (‘Flu Cell Culture’) Technology

Overview

The first major innovation in influenza vaccine manufacturing in more than 50 years, cell culturederived
influenza vaccine technology (also known as “flu cell culture”) is a production process
for the manufacturing of influenza vaccine that utilizes cell cultures rather than chicken eggs for
antigen production. Current egg-derived vaccine production requires up to nine months, a leadtime
that can hinder the response to unanticipated demands such as the discovery of pandemic
strains, production failures and seasonal influenza virus strain changes. In contrast, cell culturederived
influenza vaccine production enables flexible, faster start-up of vaccine manufacturing,
providing a particularly important advantage in the event of an influenza pandemic.

Novartis Vaccines is advancing influenza vaccine production in cell cultures to bring reliability
and flexibility of the manufacturing process to the next level. With the advent of this technology,
Novartis Vaccines is making it possible to meet the growing need for seasonal influenza
vaccines and quickly respond to a potential pandemic influenza threat.

Advantages

This next-generation technology offers a number of advantages over traditional, egg-based
vaccine manufacturing. The most important advantages are:

· It is potentially quicker in the event of time-critical (pandemic) situations. A major
advantage of cell culture-derived influenza vaccine, where eggs are no longer used, is
that the lead-time to order and take delivery of eggs is eliminated. Under egg-based
manufacturing, the specially certified eggs for annual influenza vaccine production
have to be ordered with a lead-time of up to one year. In contrast, the cells for
influenza vaccine production based on cell culture are always available.
·  It is more flexible. The required amount of cells is determined at the start of
production, and can then be developed – as needed – from a small quantity of deep
frozen seed-cells for influenza vaccine production in a few days or weeks.
·  It is independent of eggs. No chicken = no egg = no vaccine; this is the simple
equation for the traditional egg-based production. Highly poultry-pathogenic (i.e.
dangerous to poultry) viral strains can cause delays in the start of production of a
vaccine in the event of a pandemic of avian influenza.

Five Steps Production Process:

1. Cell Proliferation

The basis for the new cell culture-derived vaccine technology is the so-called Madin-
Darby Canine Kidney (MDCK) cell line, which originated in 1958 from the kidney of a
healthy dog. This MDCK-cell line was optimized for the production of influenza vaccine
and tested with numerous virus variants. It has proven to be particularly suitable for the
production of influenza vaccines. The MDCK cell line grows in suspension, and thus
requires no surface to proliferate; this factor considerably simplifies industrial production.
For production, minimum amounts of stored cells are thawed and proliferated in several
steps: At each stage the cells receive the optimal environment for their growth, with
respect to temperature, pH value and the nutrient solution. The proliferation of the cells
in fermenters (stainless steel tanks) is constantly monitored. Cell proliferation takes
place in a contained fermenter system in so-called clean rooms, resulting in maximum
safety and purity for employees, environment and product.

2. Virus Proliferation

Once introduced, it takes the selected virus strain several days to multiply in the cells.
During the course of this process, the cells die off and viruses are released in the
medium.

3. Purification

The first step of a long series of purification procedures is the ‘so-called’ separation, by
which the virus solution is separated from the cell residue. The virus is then separated
from the medium solution, and the volume is reduced ten times.

4. Inactivation and Splitting

Following purification, the virus is inactivated via a chemical process. Virus splitting
follows, as only fractions of specific surface proteins are required for the subsequent
influenza vaccine. Since the seasonal influenza vaccines contain three viral strains, the
production process must be performed three times.

5. Mixing, Filling and Release

All in all, it takes about 16 weeks from the extraction of the cell until a finished seasonal
influenza vaccine is packaged and ready for delivery.

Importance of Cell Culture-Derived Influenza Vaccine in Pandemic Response

The new production process gains greater importance in view of an increasing risk of an avian
influenza pandemic. A suitable vaccine against an influenza pandemic virus must be
manufactured in the largest possible quantities as quickly as possible. The production facilities
as well as the new cell culture-derived influenza vaccine facility of Novartis Vaccines will play an
important role in this race against a pandemic influenza virus, due to the shorter lead-time for
production. This production is not dependent on chicken eggs, which in the event of an avian
influenza pandemic might not be available in sufficient quantity, due to a virus deadly to birds.

# # # # #

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#2) On June 12, 2009 at 7:40 AM, portefeuille (99.60) wrote:

... and from that by virtue of google this article.

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#3) On June 12, 2009 at 7:58 AM, portefeuille (99.60) wrote:

(link 3 from that comment is no longer working. It led to a pdf-document by Novartis (NVS) on their ("egg-free") influenza vaccine production)

link 4 from that comment is still working -> NVAX (!)

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#4) On June 12, 2009 at 9:50 AM, portefeuille (99.60) wrote:

some current news

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#5) On June 12, 2009 at 12:18 PM, portefeuille (99.60) wrote:

The NVS chart looks "interesting" as well. It is currently trading above the upper end of the recent "trading range" and above the February 2 low.

I am not sure which chart is more relevant, the one in USD or the one in CHF. The latter one looks even more interesting. I think.

While we're at it: this chart ...

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#6) On June 13, 2009 at 6:02 AM, portefeuille (99.60) wrote:

And by virtue of our "caps" game TA expertise a much better version of the NVS chart in comment #30 here. Thank you again, goodvibe4ever!

anchak wrote this: 

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Incidentally Novartis is a great company.....can't say too much about the charts.....by the looks of it.......the whole crash seems to be Wave {1}.....

and this is looking to be a A-B-C (3-3-5) - and this is 5 of C.....target is only 42.60 to 43.20

My 2 cents

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#7) On June 13, 2009 at 12:16 PM, camistocks (< 20) wrote:

Is it a coincidence that we have a new "pandemic" around a major bottom of the stock market? Last time it was SARS and I believe it hit in 2002...

Re NVS: As long as Daniel Vasella continues to be Chairman and CEO I would avoid Novartis. Since he is at the top many years ago already he receives $20m Swiss francs every year.

But it's still nice to see that they have developed a new way to make a vaccine.

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#8) On June 13, 2009 at 12:20 PM, portefeuille (99.60) wrote:

okay, habe verstanden ...

schönes wochenende

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#9) On June 13, 2009 at 12:22 PM, portefeuille (99.60) wrote:

Maybe you should develop that correlation theory somewhat further. You might be on to something.

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#10) On June 20, 2009 at 7:02 PM, portefeuille (99.60) wrote:

more "medical news": 1,2

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#11) On July 18, 2009 at 10:57 AM, portefeuille (99.60) wrote:

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a guide to my blog posts can be found in the comment section to this post
(should be or should be close to the last comment)                                                               
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