Thursday 30 November 2023

Microbiology News: Antimicrobials and mother’s microbiome




There is much of interest in the world of microbiology, with new areas to explore emerging in recent years, including the importance of the microbiome in affecting health and disease (that is the microorganisms and genetic interactions within a given niche) and with the continued rise in cases of antimicrobial resistance, which presents a major risk to the health of humanity. We explore stories relating to both of these areas, together with news relating to some of the earliest recorded cases of parasitic infection.


Bacterial resistance to two critical antibiotics widespread in Southeast Asia


Resistance to two critical antibiotic types, one a “drug of last resort” when all others fail against some “superbugs,” have been shown to be widely distributed in Southeast Asia, raising the risk of untreatable infections, say a team of investigators led by Georgetown University Medical Center. The picture the data paints is of a serious emerging public health threat.

The research has been published in the International Journal of Antimicrobial Agents, with the research paper titled “Carbapenem and Colistin Resistance in Enterobacteriaceae in Southeast Asia: Review and Mapping of Emerging and Overlapping Challenges.”


Ancient feces reveal how ‘marsh diet’ left Bronze Age Fen folk infected with parasites


New research shows how the prehistoric inhabitants of a settlement in the freshwater marshes of eastern England were infected by intestinal worms caught from foraging for food in the lakes and waterways around their homes. Preserved in the surrounding mud were waterlogged “coprolites” — pieces of human faeces. By uisng microscopy techniques to detect ancient parasite eggs within the faeces and surrounding sediment, the researchers found the earliest evidence for fish tapeworm and giant kidney worm in Britain. This was the result of dumping of excrement into the freshwater channel.


These findings are published in the journal Parasitology (“Intestinal parasites at the Late Bronze Age settlement of Must Farm, in the fens of East Anglia, UK (9th century B.C.E.)”).


Mode of delivery at birth may play key role in shaping the child’s skin microbiome


The maturation of skin microbial communities during childhood impacts on the skin health of children and development of the immune system into adulthood, based on a new study examining the microbiota in young children. Here investigators in China discovered that bacterial genera in children were more similar to those of their own mothers than to those of unrelated women. These data suggest that the mode of delivery at birth could be an important factor in shaping the child’s microbiome.


This study has been reported to the Journal of Investigative Dermatology, with the research paper headed “Age and Mothers: Potent Influences of Children’s Skin Microbiota.”

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Sunday 19 November 2023

The Booming Biopharmaceuticals: How Contract Companies Respond


In response to our industry's large carbon footprint1, an increasing number of organizations have made maximizing sustainability a top priority for their operations. Encouraged by efforts such as the EU's "Green Deal," many businesses are actively embracing an environmental conscience and exploring innovative methods to reconcile economic performance, social responsibility, and environmental effect.


By Richard Parkersic


As the volume and ambition of these commitments expand, supply chain partners will see this trend mirrored in RFPs. Biopharmaceutical businesses are increasingly looking for collaborations that help them achieve both their commercial and sustainability goals, whether it's through eco-friendly package design, carbon-neutral production facilities, or less resource-intensive operations.


This tendency will be especially important for manufacturers. CDMOs will not only need to figure out how to successfully map new client needs.




Biopharma, which has long been a technology behind, has now begun a delayed, pandemic-fueled digitalization sprint. Countless organizations have rushed in the last two years to virtualize their workforce, move their teamwork to the cloud, and use technology to keep their operations operating while keeping their people safe.


Service providers are no exception, and they show no indications of slowing down their fast digitization. AI and machine learning-powered industrial solutions are gaining traction, with automation and robots driving considerable improvements in supply chain productivity. Expect further investment in devices like these while pandemic concern persists.


Strategic Partnerships

Another long-standing impediment is the ever-increasing expense of bringing new medications to market. Biopharma businesses will continue to strive to reduce the "total cost of ownership" involved with developing, producing, and commercializing their medications this year. This will result in a greater emphasis on not just the function but also the value of outsourced collaborations.



As astute service providers have realized, biopharma businesses seek third-party specialists who do more than fill a skill gap or allow an in-house team to focus on key skills. Customers are increasingly searching for suppliers that can provide a strategic, value-added combination of specialized services, customized solutions, and efficient operations throughout as much of the value chain as feasible.


In response, CDMOs aggressively seek new collaborations, particularly between producers with complementary expertise or complementary skill sets. Several high-profile CDMO partnerships have lately formed, with the purpose of synchronizing knowledge in ways that reduce time-to-market, expedite technical advancements, and provide considerable long-term value to consumers.


Integrated Services

One significant trend we notice is that pharma innovators are increasingly collaborating on an integrated basis with their CDMO. Initially, CDMOs were largely focused on early-stage development, assisting customers in obtaining an investigational new drug (IND) application. Integrated CDMOs, such as Piramal Pharma Solutions (PPS), now help firms across the whole development process, including late stage and commercial programmes.



This trend is being driven by a number of causes. Integration offers intrinsic advantages in terms of market speed and cost efficiency. It is easier to transfer technology within a single organization. Similarly, many project parts can be managed by a single, key point of contact for project management. Supply chain integration, with synchronized material, provides further benefits.


The Supply Chain and the Pandemic


Everyone has seen how the epidemic has disrupted global supply chains over the last two years. The pharmaceutical supply chain is especially complicated—possibly the most complex of any sector. Specialization is a big element; our supply chain is extensive, worldwide, and includes high-demand minerals. There is a global movement towards rethinking the global supply chain, which includes reshoring, increasing supplier redundancy, rethinking logistics, and upgrading systems and procedures to guarantee that supplies are easily accessible.




PPS tackled the issue head-on through its supply chain risk mitigation team. They tried to categorize and prioritize the raw materials we use, categorizing them according to whether they were utilized in novel or commercial goods and rating them according to particular risk factors. The risk criteria included information such as a product's commercial potential, manufacturing location, whether it was sourced from a single source, present availability, dependency on China, and procurement value. The team suggested unique risk mitigation techniques based on the scope and type of the dangers associated with a raw material in order to achieve rapid, efficient, effective, and long-term outcomes.


Supplying Advanced Therapeutics Demand

Because of the rapid rise of new modalities like cell and gene therapy, many corporations are foregoing costly efforts to establish internal production capabilities. Instead, they are looking for partners that can supply the advanced manufacturing practices, technical expertise, and technology required across all modalities to get medicines closer to commercialization.


In these sectors, innovation and knowledge have grown rapidly, and there is an urgent demand for development and production partners that can solve obstacles quickly. These issues include scaling up robust processes, optimizing analytical techniques, increasing yields, and integrating upstream and downstream processing with raw material supply chains to boost efficiency.


CDMOs are also an important element of the manufacturing supply chain for new medicines, therefore they must guarantee that sufficient capacity is available to innovators to fulfill demand. As a result, researchers are being forced to seek out collaborative partners early in the development process to guarantee capacity is accessible when needed.


Model of Virtual Pharma Business

Smaller biotechs, defined as firms with revenues of less than $250 million or listed companies with a market valuation of less than $2.5 billion, are driving much of the innovation in biopharma pipelines. There are over 5,500 of these businesses, and we anticipate that by 2026, they will contribute more than 60% of biopharma growth while having little or no in-house scale-up capabilities. These companies are looking to partner with CDMOs through a "virtual pharmaceutical" business model that allows them to simplify and accelerate development, hit milestones, and retain ownership without investing significant capital in infrastructure.


These smaller businesses frequently have insufficient in-house resources to maintain CDMO relationships.


Pharmaceutical Microbiology Resources (

Tuesday 14 November 2023

Performance evaluation of the sterilization process with Bowie & Dick test and biological indicator

 By Priorclave North America - Own work, CC BY-SA 4.0


An article of interest:

Managing contaminated waste in blood banks is a crucial process that must end with the safe disposal of blood products. In this sense, practical methods and indicators must be used to guarantee the operability of autoclave equipment and the sterility of treated waste to mitigate the risk of biological exposure and hospital biosafety. We designed a cross-sectional study to evaluate the performance the autoclaving process with Bowie & Dick test and biological indicator at the Hemotherapy and Blood Bank Unit of the Cayetano Heredia Hospital in Peru. 


Fifty autoclaving processes were carried out independently for the Bowie & Dick tests and biological indicators based on Geobacillus stearothermophilus spores. Autoclaving was programmed at 134°C for 3.5 minutes for the Bowie & Dick test, while, for the biological indicator, it was programmed at 121°C for 5 minutes. Both in the presence of contaminated waste. 


The autoclaving process evaluated by the Bowie & Dick test had a compliance rate of 80% (CI95: 66.3%–90.0%), while, by the biological indicator, 90% (CI95: 78.2%–96.7%). We did not find significant differences between the results of both tests (P = .689; Fisher exact test). The compliance rate in the autoclaving process within the blood bank of a Peruvian Hospital is acceptable; however, there are actions for continuous improvement, especially at the vacuum level in the autoclaving process.


For details, see: Autoclave control 


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Tuesday 7 November 2023

AS9100 vs. ISO9001: Which one is better?


Quality is a crucial part of almost every business but these measures become even more essential when it comes to the aerospace sector and defense sectors. When quality management is not done right in either the defense or aerospace sector many lives can be at stake. 


By Sam Andrew


Understanding the importance of quality management is very important in any organization because it is linked to almost every aspect of the company. From manufacturing to delivering products successfully to the customers quality management plays a role at every level. To maintain this quality in any organization two standards are known worldwide ISO9001 and AS9100. In this blog, the differences between these standards are explored which can help you identify which standard can work best for you.


What is AS9100?

AS9100 is a quality standard that is specially designed to fulfill the quality requirements of the aerospace sector and it is often referred to as the extension of the ISO9001 standard. This standard is supposed to be enhanced in comparison to ISO9001 and is based on the objective of ensuring, that services and products in the aerospace industry meet the highest quality standards. 


What is ISO9001?

ISO9001 is a globally known standard when it comes to managing quality in any organization. This standard is not industry-specific but is applicable to every industry and includes a framework to enhance the overall quality. This standard is also considered as the fundamental requirement of quality and principles in this standard are focused on the requirements of customers and motivate management. The goal of this standard is to make sure customers get the best quality services and products and by doing so, it benefits the businesses. Companies can become ISO Certificate Training Services after detailed training and passing the audit. 


Now let’s focus on their differences based on the following measures:


Industry focus

AS9100 is industry-specific and is designed to meet the requirements of the aerospace sector only. Whereas, ISO9001 is designed to meet the requirements of every industry and work as a general standard to maintain quality. 



When it comes to implementing AS9100 in the aerospace industry, requires detailed quality control measures to ensure the levels of safety and production quality. Whereas, ISO9001 is a general framework that is required to be implemented and is based on less specific requirements when it comes to a specific industry.


Regulatory compliance

AS9100 is based on international regulations and standards such as based on the regulations of the EASA European Union Aviation Safety Agency. On the other hand, ISO9001 does not have specific reference to the regulations which makes it less specific.


Risk management

Risk management for the AS9100 is tailored and considered strictly to meet the requirements of the aerospace sector. On the other hand, ISO9001 promotes risk-based thinking that is not industry-specific but based on the overall guidelines and scenarios.


Product Safety

AS9100 has a strong impact on product safety based on the sensitive nature of the aviation sector and requirements. Whereas ISO9001 is all about the organizational measures and requirements but is quite general when it comes to the safety of the products. 


Managing suppliers

AS9100 pays huge attention to supplier management and focuses on the quality of the materials to ensure the safety of the aerospace sector. On the other hand, ISO9001 offers a huge set of guidelines that can help with evaluating suppliers in any industry.


Both are related

It is already mentioned above that AS9100 is derived from the ISO9001 which means that every clause in the ISO9001 is followed in the AS9100 which makes both standards quite identical but still, there are some differences that are discussed above. ISO is known as the base standard and it provides a direction for the organizations to refine their methods of delivering quality to their customers. 


Both standards are based on the following measures inside the organization when it comes to delivering quality.


Prioritize customers

Identification of the requirements of the customers is considered the most important part of the quality standards because, in the end, every organization needs to satisfy its customers. 


Organizational leadership

Maintaining strong leadership in an organization is an effective way to balance and manage quality in any organization. 



Employees are the backbone of any business, training them and engaging them at every level is the top priority of every quality standard either ISO9001 or AS9100. 


Process approach

Defining clear processes can lead to improved quality in any business sector. 


Continuous improvement

Quality standards aim to bring improvement continuously so that organizations become able to maintain their position in the fast-growing market, especially when it comes to the aerospace sector. 


Decision making

Quality standards focus on the collection and analysis of the data which can be an effective way to promote correct decision making and can help with mitigating risks. 


Supplier management

Analyzing and managing suppliers can have a huge impact on quality because it can also lead to better cost management. 



This article has discussed both standards along with their differences and their requirements. It can be concluded that both standards are essential when it comes to managing quality in an organization. 


AS9100 is an industry-specific standard that is specially designed to fulfill the requirements of aerospace and defense companies because of their specific needs and sensitive nature. 


Whereas, the ISO9001 standard is a universal quality standard that can be applied in any industry and can meet the quality requirements of the sector. Understanding the differences between both standards can be helpful for you because it can help you choose intelligently. AS9100 can also be tailored to meet your organization’s specific needs so, choose wisely and meet the quality requirements of your business.


Pharmaceutical Microbiology Resources (

Special offers