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October 1998

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Subject:
From:
Jeff Werner <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 8 Oct 1998 08:51:40 -0400
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Greg,

Where could I get a copy of Paul Hargreaves comments?

Thanks

Jeff





"Carrier, Greg" <[log in to unmask]> on 10/08/98 07:41:46 AM

Please respond to The Pharmaceutical Microbiology Mail List
      <[log in to unmask]>

To:   [log in to unmask]
cc:    (bcc: Jeff Werner/Cambridge/Biogen)
Subject:  Re: [PMFLIST] Nanobacteria




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Reference Paul Hargreaves dissertation at PDA/FDA conference relative to
this subject.  In the 10/7/98 forum on Aseptic Processing, this was
given as a reason why European authorities will not support aseptic
filling of a product unless it is absolutely proven that the product
cannot be terminally sterilized.  And so it begins....  "who are you",
or "what do you want"...
-----Original Message-----
From: Scott Sutton [mailto:[log in to unmask]]
Sent: Tuesday, October 06, 1998 8:14 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Nanobacteria

Jeff,
I think the critical thing here is the fact that they have been
isolated only out of serum.  You didn't mention the nature of the
biopharmaceutical company - if they were making vaccines, then this
may be a concern.  There is no evidence that they can even suvive in
pharmaceutical, aqueous formulations.
The authors also assert that the organisms are resistant to heat
disinfection (although I was unable to find their data).
I am somewhat suprised that field inspectors are asking about this
already.
Scott
On Tue, 6 Oct 1998 07:38:39 -0400, you wrote:
>Members:
>
>Scott Sutton recently posted a request for information about
>'Nanobacteria'. Yesterday, I received a call for information from a
>colleague at a local, licensed biopharmaceutical company in which he
told
>me that FDA had just questioned him about this 'genus' which he'd never
>heard of. I did a 'Yahoo' search and there are a number of URLs listed
in
>addition to the PNAS reference which Jerry Masover provided. I thought
I'd
>provide a short summary of what I learned:
>
>Nanobacteria are coccoid bacteria (Nanobacterium sanguineum gen. et.
sp.
>nov.)which were isolated from sterile, commercial FBS by a research
group
>at the University of Kuopio, Kuopio, Finland around 1996. They can pass
>through
>0.1 uM filters although they have cell walls and are highly
heat-resistant.
>They were not culturable in standard microbiological media but could be
>cultured under cell culture conditions (with or without mammalian
cells,
>5-10% CO2). Multiplication could be prevented by gamma irradiation and
high
>doses of aminoglycoside antibiotics and other agents.  They have been
>isolated from more than 80% of commercial FBS and newborn bovine sera
and
>are the most common contaminant present in cell cultures. It is
postulated
>that this may be the reason why only about 10% of FBS batches support
cell
>cloning. They are cytotoxic to mammalian cell culture in high
>concentrations relative to the mammalian cells by triggering cells that
are
>normally phagocytic to engulf them. "These organisms seem to be one of
the
>causes for cell vacuolization, poor thriving and unexpected cell lysis,
>problems not rarely encountered in mammalian cell culture and often
>attributed to cell senescense." They are not detectable with present
>sterilty testing methods. The organisms have been found in both human
and
>cow blood. The authors have suggested an association between these
>organisms and the formation of kidney stones.
>
>
>Jeff
>VP, PMF
---------------------
Scott Sutton, PhD                    [log in to unmask]
The Microbiology Network             http://microbiol.org
The Virtual Library: Microbiology    http://microbiol.org/vl_micro/

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