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article imageNew technologies and risk assessments needed for medicinal safety Special

By Tim Sandle     Dec 1, 2017 in Science
Oxford - The need to invest in new technologies and a call for a new paradigm for approaching risk assessment were the keynote messages from the 2017 Pharmig conference, which focused on making medicines safe for patients.
Despite innovations in rapid microbiological methods the pharmaceutical sector has been slow to adopt the latest technologies; moreover, the approach to assessing the risks to products is too often rooted in poor science and an over-reliance upon scoring every tiny detail with an arbitrary number. These were the messages delivered by a pharmaceutical regulator and one of the world’s foremost pharmaceutical microbiologists.
The Pharmaceutical Microbiology Interest Group (Pharmig) hosts an annual conference each year in the U.K. This year’s event took place at Heythrop Park, part Grade II listed Baroque building designed for the Duke of Shrewsbury, and part modern conference center.
The conference opened with addresses from two former chairs of Pharmig: Sharon Johnson and David Begg. Begg called on the industry not to forget what really matters - protecting patients; and Johnson queried why progress with the adoption of rapid methods was so slow.
David Begg  a former medicines inspector  addresses the 2017 Pharmig conference.
David Begg, a former medicines inspector, addresses the 2017 Pharmig conference.
Need for a less conservative pharmaceutical industry
The call for the pharmaceutical industry to be less conservative with the adoption of rapid microbiological methods came from healthcare regulator Andrew Hopkins (the pertinent points from his presentation are discussed in the article “Rapid methods needed to help safety of medicines”). Hopkins stressed that better dialogue was required between regulators and pharmaceutical manufacturers, and he outlined a forum that can be used for this purpose.
One of the exhibition stands at the Pharmig conference  with a display of the special clothing requi...
One of the exhibition stands at the Pharmig conference, with a display of the special clothing required to access production areas.
The need for a renewed focus on risk assessment came from Dr. Edward Tidswell (Merck-U.S.), who is also an expert in how microorganisms adhere to surfaces and co-editor of the book “Aseptic and Sterile Processing: Control, Compliance and Future Trends”. Dr. Tidswell, in conjunction with Kevin O’Donnell, who represents the Irish regulator agency the HPRA, said that too many risk assessments are based on a lack of data and use a poorly conceived scoring system. Called out for greatest criticism was ‘Failure Modes and Effects Analysis’ (FMEA), a risk tool commonly used in the engineering sector.
Dr. Edward Tidswell address the 2017 Pharmig conference.
Dr. Edward Tidswell address the 2017 Pharmig conference.
New paradigm for risk management
Instead, Dr. Tidswell said, quantitative risk management was needed - real-time data and lots of it. Only through big data analytics, the pharmaceutical microbiologist stated, can risks of microbial contamination transfer to a pharmaceutical product be truly understood and quantified. For this to work, and in a link back to the presentation made by Hopkins, a greater adoption of rapid methods is needed. Hence both new approaches to risk assessment and rapid methods are needed for the digital transformation of pharmaceutical microbiology.
Examples of rapid microbiological methods on show at the Pharmig conference  including real-time bio...
Examples of rapid microbiological methods on show at the Pharmig conference, including real-time biologica air-samplers.
Another presentation of note was delivered by Professor Willy Verstraete of the University of Ghent, Belgium. This presentation looked at ecological microbiology and how understanding microbial communities better is the basis for better environmental control, especially in relation to agriculture. Here biotechnology, such as the use of nitrogen-utilizing bacteria in bioreactors, can be used for such innovations as microbial protein to be used as a meat substitute. For more on Professor Verstraete’s treatise see the article “Will microbial protein replace meat on the table?"
New microbial contamination concerns
Contamination of pharmaceutical products with water-borne organisms was a theme addressed in two presentations. The first was a case study outlined by Geert Verdonk, from the German pharmaceutical giant Merck. The second was a regulatory perspective given by Dr. John Metcalfe, from the U.S. Food and Drug Administration (FDA).
David Keen  chair of Pharmig  addresses the 2017 conference.
David Keen, chair of Pharmig, addresses the 2017 conference.
In these presentations that growing regulatory focus on the organisms that form the Burkholderia Cepacia Complex was detailed, especially in relation to non-sterile pharmaceutical products. Burkholderia Cepacia Complex is a group of some twenty organisms; bacteria that are naturally resistant to many common antibiotics and thereby posing a public health hazard. If pharmaceutical products are contaminated with such organisms, then based on the patient population and the total bioburden, this would pose a risk of serious illness.
According to Dr. Metcalfe it is beholden upon pharmaceutical manufacturers to stablish procedures to prevent these objectionable microorganism contaminating of drug products. This includes having adequate procedures to assure adequate quality of incoming materials; ensuing processes are of sanitary design with appropriate maintenance and cleaning of equipment. In addition there should be production and storage time limitations, supported by the monitoring of environmental conditions.
Delegates meeting with exhibitors at the Pharmig 2017 conference.
Delegates meeting with exhibitors at the Pharmig 2017 conference.
Sanitary design was discussed by another presenter, Neil Lewis who is the Global Household Care Microbiologist at Proctor and Gamble. This looked at how alternative methodologies can be used to assess the cleanliness of equipment, arguing that legacy approaches to do not adequately address microbial risks.
New technologies on the horizon
The new technology theme was continued by Dr. Mark Sutton, who works for Public Health England. Dr. Dutton has developed an alternative means for assessing biodecontamination of clean areas. Instead of the sometimes imprecise method of adding bacterial spores onto strips of paper or stainless steel to assess microbial kill, Dr. Sutton is proposing an enzymatic test using thermostable Adenylate Kinase. This enzyme is found in all cells and it plays a role in cellular energy homeostasis.
Other presentations took different directions. Les Meader, who runs two companies - Omnia CS and Foresight Innovations Limited, discussed why human error occurs and how understanding this can be applied to pharmaceutical and healthcare manufacturing. Understanding human psychology, Meader argued, is necessary if processes are to be designed in an optimal way as so to reduce people related mistakes.
The theme of training was central to new a digital training module developed by Pharmig for those tasked with cleaning and disinfection. The online platform uses digital technology and e-learning to reinforce best practices. The module was previewed by Rachel Blount and Laura Guardi, both representing Pharmig.
Rachel Blount and Laura Guardi presenting a new interactive training video.
Rachel Blount and Laura Guardi presenting a new interactive training video.
Brexit and regulations
Andrew Hopkins gave a second presentation addressing a concoction of topics, from ways to produce pharmaceutical grade water (reverse osmosis or distillation) to Brexit (the impact of regulations on making medicines in the U.K.) His central theme was, however, Good Manufacturing Practice (GMP) and the forthcoming changes to the guidance for sterile products (Annex 1 to European Union GMP). The new guidance foster the need for a formal microbial contamination risk assessment.
The take-home messages from the conference, chaired by GlaxoSmithKline expert microbiologist David Keen, were that more can be done to protect patients in the production of safe medicines. For this, quality risk management and new technologies are the tools required to achieve this.
More about Risk assessment, rapid methods, rapid microbiology, pharmig, Microbiology
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