This week some of Europe's leading microbiologists gathered in Nottingham (U.K.) for the Pharmaceutical Microbiology Interest Group (Pharmig) annual conference. One of the key themes was keeping medicines safe from harmful microorganisms.
Pharmig
is a non-profit making professional organisation that represents the
interests of individuals who work in, have responsibility for, or work
alongside microbiology within the pharmaceutical, healthcare, cosmetics
and healthcare sectors. Each year Pharmig hosts the only U.K. and Irish
conference for microbiology professionals working across these sectors,
and the conference attracts scientists from around the world.
These years conference was held in Nottingham, the city famous for the
legend of Robin Hood and the tales of Sherwood Forest. The conference
was chaired by David Keen (GlaxoSmithKiline).
The first speaker was Dr. Tim Sandle, who presented on the human
microbiome and the Human Microbiome Project. Dr. Sandle explained the
significance of these cutting-edge science topics for the pharmaceutical
and healthcare sectors. The Human Microbiome Project
was a U.S. National Institutes of Health initiative that set the goal
of identifying and characterizing the microorganisms which are found in
association with both healthy and diseased humans (the human
microbiome). One aspect that Dr. Sandle focused on was the ecology of
the human skin, which he explained as being composed of a series of
niches. Knowing far more about the human microbiome, Dr. Sandle argued,
means that companies involved in producing medicines must focus on how
well their staff gown (in relation to wearing clean clothing) and
consider more fully how disinfectants - necessary for keeping clean
areas under control - are qualified. "Are we", he asked, "using the
right types of microorganisms, particularly those known to inhabit the
richest areas of the skin microbiome, to show that our disinfectants are
fit-for-purpose?"
This presentation was followed by a commercial pitch about keeping
microbial cultures pure. The next main presentation was from Patrick
Nieuwenhuizen, from Genzyme Ireland. Patrick considered how well
operators who are tasked with the manufacture of medicines are trained.
Patrick came up with some imaginative strategies for instilling good
training, which included the use of video recordings. Patrick also
demonstrated how poor behaviors can lead to potential contamination of
medicines.
Following this the meeting proceeded to open discussion sessions. Here
delegates opted for different specialist subjects. These subjects
included cleanrooms (the environments within which pharmaceutical
products are made); bacterial endotoxins (a fever inducing bacterial
by-product which is of particular concern with medicines administered
intravenously); using a broader range of microorganisms to show that
the culture media used to assess environments is suitable; and an
experts' corner.
The next main presentation was delivered by Elaine Doyle (Abbott
Laboratories). Elaine provided an approach for auditing and
self-inspection, so that the pharmaceutical industry can ensure that its
practices and contamination control strategies are suitable.
Leading on from this, Alan Whipple (GlaxoSmithKline) discussed when
knowing the species of a potentially contaminating microorganism is
important, and he provided some useful advice on a microbial
identification strategy. The final presentation of the first day was
from Mary Anne-Weatherhead (Pfizer). Mary-Anne argued that more
microbiologists should take on senior quality roles in organizations,
especially because the microbiological knowledge is key for product
safety and efficacy.
On the second day of the conference, Kevin Wright, who is a scientist
based at , Procter & Gamble, looked at the importance of controlling
microbial populations (bioburden) early on in the pharmaceutical
production process. Such attention, Kevin stated, leads to safer
medicines.
The second topic was carrying out effective investigations when
contamination events occur. This was led by Joanne Spiers, from the
company Catalent Pharma Solutions. Joanne provided delegates with a
series of problem solving tools that can aid efficient investigations.
The next session was introduced by Dr. Samantha Westgate of the company
Perfectus Biomed. Dr. Westgate looked at the contamination of water
systems though types of microbial communities called biofilms.
Here it was explained that bacterial adhesion is a consequence of the
balance of attractive and repulsive physicochemical interactions between
bacteria and surfaces. This phenomenon can lead to water systems, if
they are not properly controlled, from coming contaminated. Once they
have taken foot, biofilms are very difficult to remove.
The penultimate session was delivered by Dr. Mark Sutton, from Public
Health Englanbd. This centered on faster and more effective ways of
ensuring that sterilization process, especially those that rely on gases
like hydrogen peroxide, can be assessed more rapidly and effectively.
The final session took the form of an entertaining lecture from
Professor Val Edwards-Jones (Clinical Director at MelBec Microbiology).
Professor Edwards-Jones noted that there is huge concern in the
microbiology community about the increasing numbers of multi-antibiotic
resistant bacteria in the health care environment. She noted that
infections associated with these organisms have a higher fatality for
those persons undergoing complicated medical treatment. In light of
this, the Professor asked "Should we be worried?" Indeed there is
evidence that these organisms have now spread into the general community
and microbiologists have isolated some common everyday objects,
including household pets. Noting the seriousness, Professor
Edwards-Jones explored the relevance of these problems to the general
public and how prevention of some common infectious diseases can be
achieved by following good hygienic practices.
The Pharmig conference closed on a high note, with the delegates
informed on a range of important topics that can each add to the process
of making pharmaceutical products safer.
Posted by Tim Sandle
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