Biobased food packaging through the eyes of the consumer

What do consumers think of biobased food packaging? And can manufacturers and retailers strengthen the brand position of their food products by choosing biobased food packaging?

Within the COMBO public private partnership, Wageningen University & Research is helping the food sector make well-founded, sustainable packaging choices.

Companies in the food sector are looking for alternatives to regular plastic packaging to reduce their CO2 footprint. With some exceptions, recycled food packaging is not suitable to be reused as food packaging for food safety reasons. This is why packaging made from renewable raw materials is the only sustainable option for the vast majority of food products. “This transition to biobased has to be made carefully,” says Karin Molenveld, scientist at Wageningen Food & Biobased Research. “First, the new packaging must have the right functional properties. But we also need to know how consumers respond to the new packaging and how consumer opinion reflects on the brand.”

Drop-in biobased packaging requires good communication

Molenveld and her colleague Koen Meesters are performing desk research within COMBO into the development of biobased packaging and perceptions among consumers. They found that many manufacturers and retailers choose drop-in biobased packaging, which is chemically identical to the traditional packaging but made from renewable raw materials instead of petroleum. Molenveld: “Consumers immediately notice the difference between biobased packaging with a totally different material composition from the regular packaging. 

The packaging may have a different appearance or the biobased plastic feels and sounds differently than what they are used to. Consumers experience this as positive. But a ‘fossil’ PET bottle cannot be distinguished from a bottle made from vegetable sugars, so, if you choose to use a drop in biobased packaging, you need to clearly communicate and let the consumer know that (even though it looks exactly the same), the new material is beneficial to the environment.”

Recognisable and substantiated claims

And this communication is sensitive, Meesters adds. “As a manufacturer or retailer you have to be careful about the claims you make. You can’t just say your packaging is CO2 neutral. As it is almost impossible to prove, you run the risk of having to withdraw the claim and damaging your reputation. In other words: make sure the claim is correct. 

For example, a claim like ‘this packaging is made from plants’ cannot be contradicted. Moreover, consumers like to know what to do with the packaging after use, which is why claims about recycling and composting are included in the research.”

‘The more concrete, the better’

Machiel Reinders, scientist at Wageningen Economic Research, confirms that consumers are positive about claims on biobased packaging such as ‘compostable’ and ‘recyclable’, which clearly indicate how to dispose of the packaging product. 

Within COMBO, his institute performed quantitative research among German and French consumers who indicated that they care about sustainability. “Our research shows that consumers prefer clear claims. Stating that products can be discarded with the organic waste is a good example. The more concrete the sustainability benefits, the better the packaging is evaluated.”

Sincere intentions matter

The German and French consumers were presented with three varieties of five packaging products: a traditional variety, a fully biobased variety and a variety in-between. Of the three varieties, the consumers indicated that they were most likely to purchase the fully biobased product. From the water bottle to the goat’s cheese in plastic packaging, the various varieties were not evaluated significantly differently from each other. 

The awareness of packaging properties and the positive evaluation linked to them by consumers play an important role in the intention to buy products in biobased packaging. According to Reinders, a belief in the brand’s sincere intentions is also relevant.

COMBO runs until the end of 2018 and a decision as to which aspects of the research should be focused on in the coming period will be taken by the project partners together. Wageningen Food & Biobased Research invites new partners to join the programme.

Season's Greetings!

Season's Greetings!

Thank you for supporting Pharmaceutical Microbiology over this past year. The website and the various groups continues to grow and feature a range of microbiology, pharmaceutical and healthcare related news stories.

All the best for the holiday season.



Dr. Tim Sandle

Draft EU GMP Annex 1 released

The PIC/S Secretariat has notified that the revised EU-PIC/S GMP Annex 1 on the Manufacture of Sterile Medicinal Products has reached Step 2 of the revision process and on 20 December 2017, the PIC/S and EMA published the draft revision of Annex 1 for public consultation.

The consultation period will last 3 months and run from 20 December 2017 to 20 March 2018.

The revised Annex 1 has been prepared in co-operation with the EMA, World Health Organization (WHO), and PIC/S in order to maintain global alignment of standards, and provide assurance of product quality. The document is subject to parallel public consultation by the European Commission (EC), WHO and PIC/S.

Key changes from the earlier PIC/S Annex are:

• Introduction of new sections: scope, utilities, environmental and process monitoring sections and glossary.
• Introduction of the principles of Quality Risk Management (QRM) to allow for the inclusion of new technologies and innovative processes.
• Restructuring to give more logical flow.
• Addition of detail to provide further clarity.

The revised Annex 1 is downloadable on the PIC/S website (site link) or via this direct link.

The draft has been formatted with prescribed line and page numbers to support a joint international consultation within TGA, PIC/S, WHO and the EC.



Posted by Dr. Tim Sandle

2017 Author of the Year – Journal of GXP Compliance

Tim Sandle has been awarded '2017 Author of the Year – Journal of GXP Compliance' by the Instiute of Validation Technology. This is for Dr. Sandle's contributions to the Journal of GXP Compliance, includig:

Biodecontamination of Cleanrooms and Laboratories Using Gassing Systems V21 #1

Matrix Approach for the Qualification of a Pharmaceutical Facility Autoclave V21 #4

Pharmaceutical Microbiology: Current and Future Challenges V21 #4

How the immune system identifies invading bacteria

The body's homeland security unit is more thorough than any airport checkpoint. For the first time, scientists have witnessed a mouse immune system protein frisking a snippet of an invading bacterium. The inspection is far more extensive than researchers imagined: the immune system protein, similar to those in humans, scans the bacterial protein in six different ways, ensuring correct identification.

See:

Jeannette L. Tenthorey et al. The structural basis of flagellin detection by NAIP5: A strategy to limit pathogen immune evasion. Science, 2017; DOI: 10.1126/science.aao1140

Posted by Dr. Tim Sandle

How to gown properly for cleanrooms

As shown below, three videos showing how to gown properly when entering cleanrooms.

Practical workshop on good cleanroom gowning from Simon Fiala – Key Account Manager, COMPREI Reinraum.

Posted by Dr. Tim Sandle

Strain Collection for Improved Expression of Outer Membrane Proteins

An article of interest in Frontiers in Cellular and Infection Microbiology. Here is the abstract:

Almost all integral membrane proteins found in the outer membranes of Gram-negative bacteria belong to the transmembrane β-barrel family. These proteins are not only important for nutrient uptake and homeostasis, but are also involved in such processes as adhesion, protein secretion, biofilm formation, and virulence. As surface exposed molecules, outer membrane β-barrel proteins are also potential drug and vaccine targets. High production levels of heterologously expressed proteins are desirable for biochemical and especially structural studies, but over-expression and subsequent purification of membrane proteins, including outer membrane proteins, can be challenging.

Here, we present a set of deletion mutants derived from E. coli BL21(DE3) designed for the over-expression of recombinant outer membrane proteins. These strains harbor deletions of four genes encoding abundant β-barrel proteins in the outer membrane (OmpA, OmpC, OmpF, and LamB), both single and in all combinations of double, triple, and quadruple knock-outs. The sequences encoding these outer membrane proteins were deleted completely, leaving only a minimal scar sequence, thus preventing the possibility of genetic reversion.

Expression tests in the quadruple mutant strain with four test proteins, including a small outer membrane β-barrel protein and variants thereof as well as two virulence-related autotransporters, showed significantly improved expression and better quality of the produced proteins over the parent strain.

Differences in growth behavior and aggregation in the presence of high salt were observed, but these phenomena did not negatively influence the expression in the quadruple mutant strain when handled as we recommend. The strains produced in this study can be used for outer membrane protein production and purification, but are also uniquely useful for labeling experiments for biophysical measurements in the native membrane environment.

For further details see: Frontiers

Posted by Dr. Tim Sandle

How Helicobacter pylori causes gastric cancer

Gastric cancer is one of the five most fatal types of cancer. According to the statistics of the World Health Organization (WHO), about 750,000 patients die each year after developing the disease. The main cause is thought to be the bacterium Helicobacter pylori (H. pylori). At present, there are no effective therapies for gastric cancer and growing spread of antibiotic resistances is further complicating treatment of the infection. Researchers at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) have now identified two mechanisms through which this bacterium can cause gastric cancer. Their findings could result in the development of new therapeutic approaches.

The international team of scientists headed by Dr. Nicole Tegtmeyer of the Chair of Microbiology at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) investigated how bacteria destroy the stomach's protective layer. This protective layer is composed of densely packed epithelial cells that protect the stomach against the effects of gastric acid. The researchers have now discovered that H. pylori secretes an enzyme, a protease called HtrA, which it uses much like a weapon to penetrate this protective layer. HtrA cleaves the three proteins occludin, claudin-8 and E-cadherin, rupturing the layer of epithelial cells. As a result, the H. pylori bacteria can access deeper, normally pathogen-free tissue layers, and inflict further damage. This is the first step towards gastric cancer starting to develop.

This first phase, however, is followed by one that is even more dangerous, as the team discovered. Needle-like protrusions, termed type IV secretion systems, are activated and function as 'molecular syringes'. Using a receptor-dependent mechanism, these inject a bacterial toxin, the CagA protein, through the basolateral membrane of the host cells. The injected CagA subsequently reprograms host cells, making them potentially cancerous. Another effect of this protein is that it prevents the human immune system from recognising and eliminating the bacteria -- a crucial mechanism for the long-term survival of H. pylori in the human stomach.

See:

Anne E. Robinson, Nathan E. Thomas, Emma A. Morrison, Bryan M. Balthazor, Katherine A. Henzler-Wildman. New free-exchange model of EmrE transport. Proceedings of the National Academy of Sciences, 2017; 201708671 DOI: 10.1073/pnas.1708671114

Posted by Dr. Tim Sandle

Novel antibiotic resistance gene in milk

A new antibiotic resistance gene has been found in bacteria from dairy cows. This gene confers resistance to all beta-lactam antibiotics including the last generation of cephalosporins used against methicillin-resistant Staphylococcus aureus. A transfer to S. aureus which is likely according to the researchers would jeopardize the use of reserve antibiotics to treat human infections caused by multidrug-resistant bacteria in hospitals.

Macrococcus caseolyticus is a harmless bacterium naturally found on the skin of dairy cows which can spread to milk during the milking process. It can also be present in dairy products made from raw milk like e.g. cheese. Researchers of the Institute of Veterinary Bacteriology of the University of Bern have identified a new methicillin resistance gene in strains of M. caseolyticus isolated from milk. Transfer of the gene to Staphylococcus aureus, a bacterium found on the skin and mucosa of animals and humans, would have dramatic consequences for public health. This methicillin resistance gene would turn this bacteria into a hazardous methicillin-resistant S. aureus (MRSA), which is known to cause difficult-to-treat infections in hospitals. Acquired methicillin resistance in bacteria is associated with genes mecA, mecB, or mecC. However, none of these genes were present in the M. caseolyticus strains -- they carried the novel resistance gene mecD.

See:

Sybille Schwendener, Kerstin Cotting, Vincent Perreten. Novel methicillin resistance gene mecD in clinical Macrococcus caseolyticus strains from bovine and canine sources. Scientific Reports, 2017; 7: 43797 DOI: 10.1038/srep43797

Posted by Dr. Tim Sandle

Pharmig News #69

A new edition of Pharmig News has been issued, edition 69. In this issue:

• Industry reflections by David Keen.
• Part 2 of Pharmig’s industry review of culture media practices.
• Review of MHRA deficiencies – trends and topics.
• Regulatory round-up
• New Pharmig courses
• And more…

For a copy or further details, contact Pharmig (info@pharmig.org.uk)

The articles by Tim Sandle in the new edition are:

Sandle, T. (2017) Industry practices relating to culture media use: The Pharmig survey (part 2), Pharmig News, Issue 69, pp2-5

Sandle, T. and Leavy, C. (2017) A focus on regulatory trends: MHRA annual deficiency review, Pharmig News, Issue 69, pp2-5

Posted by Dr. Tim Sandle

5 Keys To Aseptic Processing Improvement & Efficiency

Today, life science products should also be affordable to patients and a reasonable business proposition for manufactures. These objectives can present challenges to manufacturers as they strive to gain production and process efficiencies.

Hal Baseman has written an interesting article for Pharmaceutical Online. Here is an extract:

• Science- and risk-based approaches should be used to obtain information needed to make decisions related to the evaluation, design, qualification, operation, and monitoring of sterile product manufacturing processes.
• Technology should be considered to mitigate or reduce the risk to product quality identified in sterile product manufacturing processes and operations.
• Traditional testing and monitoring methods as control strategies should be challenged to ensure they are the best means for aseptic processes.
• New products, therapies, and technologies will present challenges to traditional and existing methods for development, manufacture, validation, and testing of sterile products.
• Global health authority technical and regulatory guidance and requirements should be harmonized with regard to technical language and definitions.

The article can be accessed here: Pharmaceutical Online

Posted by Dr. Tim Sandle

Data-Driven Risk Management For Quality By Design

The main hope of ICH Q8-Q10 pertaining to operational excellence is to enable (bio)pharmaceutical companies to achieve product realization. The goal is to do so by establishing and maintaining a state of control and facilitating continual improvement while responding to pressures for efficiency and profitability improvements.

Peiyi Ko, Ph.D. and Peter Calcott, Ph.D. have written an interesting article on the subject for Pharmaceutical Online. Here is an extract:

“risk management is open to individual interpretations and at times has varied and been time-consuming and not-informative for prioritization, re-inventing risk assessments and leading to wasted resources and unsatisfactory outcomes. Therefore, it is proposed to use a quantitative approach with probabilistic calculations and monetized harm to account for occurrence and severity, respectively. Specifically, failure modes and effects analysis (FMEA) is a classic tool for summarizing the modes of failure, factors causing these failures, and the likely effects of theses failures to reduce process complexity for management. It generates a risk priority score for a failure mode by multiplying the ratings for severity, occurrence, and detection.”

To access the article, see Pharmaceutical Online.

Posted by Dr. Tim Sandle

Hand surgeons provide update on wild animal bites

The article was prompted by the authors' experience in treating an elderly man who developed a progressive infection of the hand after being bitten on the finger by an opossum. The patient recovered after hospitalization including treatment with intravenous antibiotics.

Dr. Rao and colleagues performed a research review to identify studies of rare animal bites and stings. While many reports have discussed treatment of dog, cat, and snake bites, there has been no recent, comprehensive review focusing on the recommended treatment and potential adverse effects of less-common types of animal bites and injuries.

The review identified 71 articles, including a total of 214 patients, describing less frequently seen bite and sting injuries of the upper limb (hand and arm). Most of the studies were case reports and patient series

Aquatic animals were by far the most commonly reported type of injury, accounting for two-thirds of studies. Stings from jellyfish, lionfish and sea anemones, as well as other venomous aquatic animals, can not only cause severe pain and swelling but may sometimes lead to severe or even life-threatening complications.

Ten percent of studies reported bites by reptiles. Bites by some of these animals, such as beaded lizards, can cause envenomation leading to systemic shock.

Other reports described serious complications resulting from bites caused by small mammals and rodents such as ferrets, skunks, and squirrels. Other categories, including just a few cases each, included serious injuries caused by large mammals, scorpions and centipedes and birds.

The studies suggested that most infections resulting from animal bites are "polymicrobial," caused by several different bacteria or other germs. Infections with multiple, often unfamiliar microbes have the potential to cause tissue destruction and systemic (body-wide) reactions.

Based on the available evidence, Dr. Rao and colleagues outline quick reference principles for the treatment of wild animal bites and stings. These include specific recommendations for preventive antibiotics, providing coverage for unusual bacteria that may be present in infected wounds.

See:

Jacqueline S. Israel, James E. McCarthy, Katherine R. Rose, Venkat K. Rao. Watch Out for Wild Animals. Plastic and Reconstructive Surgery, 2017; 140 (5): 1008 DOI: 10.1097/PRS.0000000000003754

Posted by Dr. Tim Sandle

Bacteria Have a Sense of Touch

Bacteria may not have a central or sensory nervous system as we know it, but they can still physically "feel" the world around them, according to a new study.

By MICHELLE STARR

It turns out the tiny microorganisms don't just respond to chemical signals - they also have a sense of touch, and can recognise surfaces and respond to them. Our sense of touch is a very important tool for living in the world. It helps avoid hazards and dangerous surfaces, and keeps you from crushing delicate objects.

For bacteria, it helps them determine which type of surface they're in contact with - such as a mucous membrane or intestinal wall - and therefore colonise and attack host cells.

It's what happens in the first few seconds after coming into contact with a surface that's crucial for successful infection, the researchers say.

To explore the mechanism by which bacteria sense surfaces, they studied a harmless species called Caulobacter crescentus.

"We have little knowledge of how bacteria read out mechanical stimuli and how they change their behaviour in response to these cues," says senior researcher Urs Jenal of the University of Basel's Biozentrum.

"Using the non-pathogenic Caulobacter as a model, our group was able to show for the first time that bacteria have a 'sense of touch'. This mechanism helps them to recognise surfaces and to induce the production of the cell's own instant adhesive."

Some bacteria have an appendage called the flagellum - whip-like structures that propel them around. Some have just one flagellum, others have many. The juvenile C. crescentus has a single flagellum that it sheds after a set period, or after it finds a suitable surface to adhere to.

By rotating this flagellum, the bacteria can travel through liquids. But these microorganisms don't have muscles - movement is enabled by energy generated by the transfer of protons down the cell membrane.

And it's this mechanism that allows the bacteria to "feel", the researchers have found. When cells come into contact with surfaces, the motor that drives the flagellum is interrupted. This in turn interrupts the proton flow.

Within seconds of this occurring, the bacteria responds, producing the adhesinthat will anchor it in place.

This knowledge could help us understand dangerous bacteria too, says Jenal.

"Even though Caulobacter is a harmless environmental bacterium, our findings are highly relevant for the understanding of infectious diseases," he explains. "What we discovered in Caulobacter also applies to important human pathogens."

The research has been published in the journal Science.

Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers

Did you realize that 90 percent of quality control microbiology remains reliant upon culture-based methods? Taking this fact into account, Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers serves as an excellent reference because it focuses on microbiological culture media as applied to pharmaceutical microbiology.

In 23 informative chapters, this book covers how media is used in the modern pharmaceutical microbiology setting and recaps the past, signals the future, and helps interpret the present. The book has been written by Tim Sandle.

Pre-order this book through Dec. 15 and save 15%. Enter campaign code MBCM to apply discount during checkout.

This book also takes into consideration that innovations continue to arise with new media recipes that are formulated for the selection of new strains for the application of media in conjunction with rapid microbiological methods.

If you are a microbiologist working in the pharmaceutical and healthcare sectors, you can’t afford not to own this book!

Contents:

1. Application of Culture Media in Pharmaceutical and Healthcare Microbiology
2. History and Development of Microbiological Culture Media
3. The Science of Culture Media
4. Common Types of Microbiological Culture Media for Pharmaceutical Microbiology
5. The Media Kitchen and the Preparation of Microbiological Culture Media
6. Sterilization of Microbiological Culture Media
7. Quality Control of Culture Media
8. Microbial Cultures
9. The Use of Environmental Isolates in Pharmaceutical Microbiology
10. The Colony Forming Unit
11. Microbial Identification and Visual Assessment of Colonies
12. Qualification of Culture-Based Environmental Monitoring Methods
13. Incubation Strategies for Environmental Monitoring
14. Culture Media for Sterility Testing
15. Culture Media for Media Simulation Trials
16. Culture Media for Microbial Controls During Pharmaceutical Manufacture
17. Assessment of Culture Media for Water Testing
18. Culture Media for Cell Culture Work
19. Diluents and Neutralizers Required for the Pharmaceutical Microbiology Laboratory
20. Data Integrity, Computerized Systems and Microbiological Culture Media
21. Auditing Culture Media Suppliers
22. Industry Practices Relating Culture Media Use
23. Growth and Culture Based Rapid Microbiological Methods

For more details see the PDA Bookstore

Posted by Dr. Tim Sandle