Improving understanding of biosimilars in the EU

The European Medicines Agency (EMA) and the European Commission have published additional information material on biosimilar medicines, as part of their ongoing collaboration to improve understanding of biosimilars across the European Union (EU). A biosimilar is biological medicine that is highly similar in all essential aspects to a 'reference' biological medicine already authorised.

See EMA - https://www.ema.europa.eu/news/improving-understanding-biosimilars-eu



Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Photoactive bacteria help in fight against MRSA infections

Researchers are testing whether a light-active version of heme, the molecule responsible for transporting oxygen in blood circulation, may help people infected with MRSA. Photodynamic therapy, or PDT, involves a compound known as a photosensitizer, which can be activated by visible light to kill diseased cells or bacteria. PDT is a clinically proven method for fighting cancer but has not yet been developed for treating MRSA infections.

The World Health Organization identifies MRSA as one of about a dozen antibiotic "superbugs" that pose an enormous threat to human health. WHO has listed methicillin-resistant Staphylococcus aureus, or MRSA, as one of six 'high priority' pathogens with an imminent threat to public health. The Centers for Disease Control and Prevention reports 80,461 people in the United States suffer severe MRSA infections a year and 11,285 die.

Anyone can get MRSA on their body from contact with an infected wound, or by sharing personal items such as towels or razors that are contaminated. However, patients in hospitals are especially vulnerable to MRSA infections.

"MRSA infections can cause severe problems for patients recovering from surgery," said Alexander Wei, a professor of chemistry in the College of Science who is leading the research team. "The challenge that we face is that MRSA responds poorly to multiple antibiotics. Antimicrobial photodynamic therapy offers a promising alternative for combating MRSA in infected wounds."

Photodynamic therapy, or PDT, involves a compound known as a photosensitizer, which can be activated by visible light to kill diseased cells or bacteria. PDT is a clinically proven method for fighting cancer but has not yet been developed for treating MRSA infections.

The discovery aligns with Purdue's Giant Leaps celebration, recognizing the university's global advancements made in health, longevity and quality of life as part of Purdue's 150th anniversary. This is one of the four themes of the yearlong celebration's Ideas Festival, designed to showcase Purdue as an intellectual center solving real-world issues.

The photosensitizer developed at Purdue is called Ga-PpIX, and is an analog of heme. Ana Morales-de-Echegaray, the lead graduate research assistant on the project at the time, discovered that Ga-PpIX could be gobbled up by MRSA strains within seconds, leading to their rapid inactivation using a simple light-emitting diode (LED) array that is safe to use on human skin.

"Our discovery is part of a convergence on campus to develop drugs and get them to people in need as quickly as possible," Wei said.

Wei and his collaborator Mohamed Seleem, a professor in Purdue's College of Veterinary Medicine, are working closely with the Purdue Institute of Inflammation, Immunology and Infectious Disease and the Purdue Institute for Drug Discovery to determine if this kind of treatment could work for animals and with other types of skin infection.

The technology is patented through Purdue Office of Technology Commercialization, and the researchers are looking for partners to continue developing practical applications for the discovery.

See:

Ana V. Morales-de-Echegaray, Thora R. Maltais, Lu Lin, Waleed Younis, Naveen R. Kadasala, Mohamed N. Seleem, Alexander Wei. Rapid Uptake and Photodynamic Inactivation of Staphylococci by Ga(III)-Protoporphyrin IX. ACS Infectious Diseases, 2018; DOI: 10.1021/acsinfecdis.8b00125

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Disinfectants and Biocides

Tim Sandle has written a new chapter which reviews the use of disinfectants and biocides in the pharmaceutical and healthcare sectors. This is for a new book edited by Jeanne Moldenhauer titled “Disinfection and Decontamination A Practical Handbook.”

Here is an extract:

“The regular cleaning and disinfection of surfaces is required. In addition, processing equipment requires frequent cleaning and disinfection; and periodic disinfection may be required for water systems. The focus of this chapter is on disinfectants used in cleanrooms and other controlled areas for surface disinfection, which is necessary for maintaining contamination control. The chapter considers the different types of chemicals that are available as disinfection agents; the process for their selection; their application; and how they are to be qualified through disinfectant efficacy testing. In doing so the chapter does not seek to regurgitate regulatory standards (these are sign-posted for the reader to explore); instead the chapter seeks to provide a practical approach, supported by scientific theory, for the use of disinfectants and biocides for the purposes of microbial contamination control for pharmaceuticals and healthcare facilities.”

Sandle, T. (2019) Disinfectants and Biocides. In Moldenhauer, J. (Ed.) Disinfection and Decontamination A Practical Handbook, CRC Press, Boca Raton, pp7-34

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Classifying microbes differently leads to new discovery

Changing the way microbes are classified can reveal similarities among mammals' gut microbiomes, according to a new study. The study, published in mBio, proposed an alternative method for classifying microbes that provides insight into human and environmental health.

James O'Dwyer, an associate professor of plant biology at the Carl R. Woese Institute for Genomic Biology at the University of Illinois at Urbana-Champaign, is a co-author of the NSF-funded study.

He said that, unlike many other organisms, microbial species are difficult to classify.

Traditionally, microbes are classified by using their genetic data. Scientists often use a method pioneered by Carl Woese that uses 16S ribosomal RNA to sort microbes into operational taxonomic units, or OTUs.

"If you're similar enough in genetic identity to another organism, you get clustered together," O'Dwyer said. "The problem with that is we don't really know how closely that definition of a unit corresponds to the ecological differences between microbes."

Sometimes microbes that are in the same group may look similar, but might actually be remarkably different from each other, O'Dwyer said.

He and his co-authors proposed a different approach to classification that instead focuses on the microbes' evolutionary history.

Picture three separate species. Using the OTU classification, these three species may be placed into different units based on their differing genetic information.

The researchers propose to instead look at whether these species have a shared evolutionary history. If they do, they could possibly be grouped together in what O'Dwyer says is a "more meaningful unit."

O'Dwyer said using evolutionary history "helps us in finding the needle in the haystack."

When the researchers grouped the microbes in this way, they learned more about the gut microbiomes of mammals.

The gut microbiome is the community of microbes found in the digestive tract. Scientists often determine the similarities between two species by comparing the microbial species found in their gut microbiomes.

"We found here that we might be obscuring some of those patterns of similarity by looking at these OTUs that are too fine-grained," O'Dwyer said.

When the microbes were classified differently, they found clearer patterns of similarity between closely related mammals, in terms of their gut microbiomes.

Next, they wanted to see if specific groups of microbes, or clades, were found across all mammals. After a series of statistical tests, they found that some are.

"There are patterns among these conserved clades which correlate with patterns in the host's evolution," O'Dwyer said.

It's still unclear exactly what this correlation is, but O'Dwyer said future research may answer this question.

"I hope we'll be able to resolve some of those, at least (get) more evidence for the causality of those relationships," O'Dwyer said. "We might gain some insight into why these associations between particular microbial clades and their hosts are there."

He said starting with the right species unit could help future research, especially when it comes to applying this knowledge to issues in human and environmental health.

"We want to know what are particular microbes doing, why are they there, why are they associated with different people, and what effects do those have?" O'Dwyer said. "Looking at the right units gives us a better chance at doing that."

O'Dwyer hopes the field may one day come to an agreement on a better way to classify microbes -- even if it's not the method this paper proposed.

"We hope that this study will really get people thinking about -- not just that OTUs aren't always the right unit, I think everyone in the field would agree with that," he said. "We want to get people thinking about how we can meaningfully move beyond it."

See:

Christopher A. Gaulke, Holly K. Arnold, Ian R. Humphreys, Steven W. Kembel, James P. O’Dwyer, Thomas J. Sharpton. Ecophylogenetics Clarifies the Evolutionary Association between Mammals and Their Gut Microbiota. mBio, 2018; 9 (5) DOI: 10.1128/mBio.01348-18

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Dual vaccine against anthrax and plague

A team of researchers has now engineered a virus nanoparticle vaccine against Bacillus anthracis and Yersinia pestis, tier 1 agents that pose serious threats to national security of the United States. B. anthracis and Y. pestis are the pathogens that cause anthrax and plague, respectively. Using bacteriophage T4, the scientists developed the vaccine by incorporating key antigens of both B. anthracis and Y. pestis into one formulation. Two doses of this vaccine provided complete protection against both inhalational anthrax and pneumonic plague in animal models. Even when animals were threatened with lethal doses of both anthrax lethal toxin and Y. pestis CO92 bacteria, the vaccine was shown to be effective.

The study is published in mBio, an open-access journal of the American Society for Microbiology.

"This dual anthrax-plague vaccine is a strong candidate for stockpiling against a potential bioterror attack involving either one or both of these biothreat agents," the researchers noted in the study. Their results demonstrate that T4 nanoparticle is a novel platform for developing multivalent vaccines against pathogens of high public health concern.

See:

Pan Tao, Marthandan Mahalingam, Jingen Zhu, Mahtab Moayeri, Jian Sha, William S. Lawrence, Stephen H. Leppla, Ashok K. Chopra, Venigalla B. Rao. A Bacteriophage T4 Nanoparticle-Based Dual Vaccine against Anthrax and Plague. mBio, 2018; 9 (5) DOI: 10.1128/mBio.01926-18

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Sunshine can kill some dust-dwelling bacteria

Allowing sunlight in through windows can kill bacteria that live in dust, according to a study published in the open access journal Microbiome.

Researchers at the University of Oregon found that in dark rooms 12% of bacteria on average were alive and able to reproduce (viable). In comparison only 6.8% of bacteria exposed to daylight and 6.1% of bacteria exposed to UV light were viable.

Dust kept in the dark contained organisms closely related to species associated with respiratory diseases, which were largely absent in dust exposed to daylight.

The authors found that a smaller proportion of human skin-derived bacteria and a larger proportion of outdoor air-derived bacteria lived in dust exposed to light that in than in dust not exposed to light. This may suggest that daylight causes the microbiome of indoor dust to more strongly resemble bacterial communities found outdoors.

The researchers made eleven identical climate-controlled miniature rooms that mimicked real buildings and seeded them with dust collected in residential homes. The authors applied one of three glazing treatments to the windows of the rooms, so that they transmitted visible, ultraviolet or no light. After 90 days, the authors collected dust from each environment and analysed the composition, abundance, and viability of the bacteria present.

See:

Ashkaan K. Fahimipour, Erica M. Hartmann, Andrew Siemens, Jeff Kline, David A. Levin, Hannah Wilson, Clarisse M. Betancourt-Román, GZ Brown, Mark Fretz, Dale Northcutt, Kyla N. Siemens, Curtis Huttenhower, Jessica L. Green, Kevin Van Den Wymelenberg. Daylight exposure modulates bacterial communities associated with household dust. Microbiome, 2018; 6 (1) DOI: 10.1186/s40168-018-0559-4

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Role of humidity neutral oxygen scavengers in protecting pharmaceuticals

For any Pharmaceutical company, maintaining the desired standard quality of the pharmaceuticals from the storage to till the distribution is a challenging task. Therefore, special measures which are appropriate to avoid contamination from chemical or microbial nature which flourishes in presence of moisture and oxygen need to be observed and practiced which affect during quality control. One such measure which is practiced by Pharmaceutical companies which turned out to be effective during packaging is the interjection of humidity-neutral oxygen scavengers in the containers. These Oxygen scavengers absorb oxygen from the moisture present in the surrounding environment in a package thereby inhibiting microbial reproduction, which causes degradation of active ingredient of the medicine. Oxygen scavengers act as a means in reducing the oxygen content as well as the moisture content inside the pharmaceutical packaging and ensure the physical stability of the drugs. Not only microbial, chemical factors such as extreme levels of pH can also be controlled using these Oxygen Scavengers. Pharmaceutical Decomposition due to hydrolysis is also restricted by deploying Oxygen Absorbers.

Guest post by Drashti Dave.

Oxygen scavengers or Oxygen absorber are made or synthesized from chemicals which are non-toxic and non-editable available in the form of Oxygen Absorber Packets or Oxygen Absorber Sachets.

What is in Oxygen Absorber Sachets?

Oxygen Absorber Sachets are porous sachets which contain ferrous iron powder along with activated carbon and salt having a tendency of attracting or suspending the water molecules in between them based on the hygroscopic phenomenon and thereby absorbs the total oxygen content present in the surrounding atmosphere in a package.

How to use Oxygen Absorber packets?

Since pharmaceutical products remain in a closed package for longer periods, the moisture levels inside the package increase with a slight increase in relative humidity and temperature in the surroundings. Therefore, Oxygen absorber which is available in packets or sachets is placed in the packages containing pharmaceutical drugs do increase the rate of absorption of oxygen and prevent the ingress of oxygen. Transportation of commodities like Pharmaceutical products in bulk quantities is performed through depending mainly on sea logistics. There are many other modes of transportation, but sea logistics serve to be cost-effective unless the Containers are subjected to Container rain. Therefore these Oxygen Absorbers Sachets Place inside the containers or even inside the packages serve to be a better absorbent or dehumidifier in withstanding the extreme climatic conditions prevailing around the containers during transportation. Therefore, before shipment placing the Oxygen Absorber Sachets are placed at the bottom or side walls of the containers help in maintaining the thermal variations throughout the period of transportation and thereby contributing for the safe passage of Pharmaceutical commodities.

Ageless Oxygen Absorbers:

Since the Oxygen Absorber packets play a major role in extending the shelf life of packages they are named as Ageless by the patents as they protect the Pharmaceutical Packaging materials with low RH environments and preserve them for a longer period. They are trade named as ageless Oxygen Absorbers and are available in Sachets forms with specifications such as “oxygen absorption capacity-C” and headspace of the containers. These specifications make their deployment easy for preservations for a limited period of time.

• 100ccOxygen Absorbers: It is used for Vacuum Sealed Pharmaceutical packaging containing one package for long time preservations such as Vitamins.
• 300ccOxygen Absorbers: It is used for Vacuum Sealed Pharmaceutical packaging containing more than one package for long time preservations.
• 500ccOxygen Absorbers: It is used for Vacuum Sealed Pharmaceutical packaging containing bulk quantity for long time preservations.

All these 100ccOxygen Absorbers, 300ccOxygen Absorbers, 500ccOxygen Absorbers are specially designed to store emergency pharmaceutical products for longer periods. These are available in Mylar bags which are specially designed by BoPet (Biaxially-oriented polyethylene terephthalate) plastic which is sandwiched between two thick aluminum Foils. The features such as-transparency, chemical-stability, insulating capacity makes it viable and is used for commercial applications such as Oxygen Absorbers packing which in turn are used for storing packed products with chemical origin. It also meets the pharmacopeia, regulatory limits. This Oxygen absorber sachet reduces the access of heat, protects the medicinal products from light, act as water-proof and regulates the oxygen transmission levels.

The growth rate usage Of Oxygen Absorbers in Healthcare and Pharmaceutical preservations globally is expected to grow, thereby increasing the production Volume. Therefore, Oxygen Absorber manufacturers in India, which supply Industrial Units pertaining to Healthcare preservations and Pharmaceutical preservations on a large scale as well as on a small scale, based on quality assurance and performance criteria are also flourishing well. Since, Oxygen Absorbers can be used for a wide variety of storage of drugs which include-Anti depressants, anti-anxiety drugs, Cannabis, Dissociative Drugs, Hallucinogens, Narcotics, Stimulants and many more, employing the best suppliers of oxygen absorbers, who are rendering their services in delivering the Absorbents according to the specifications and Dimensions meeting both Small scale as well as Large-scale requirements are of utmost importance.

The Global competitive standards of humidity-neutral oxygen scavengers to meet the Pharmaceutical applications are growing day by day because of their excellent absorption capacity of oxygen at varying RH. As the relative humidity increases the adsorption capacity of the absorbers also increases. Therefore, quality standards of oxygen absorbers cannot be compromised, since they last for longer periods along with the packages until the delivery. Before placing the order for oxygen absorber packets these guidelines are helpful in safe storage of Pharmaceuticals causing no harm to public health and the environment. The aspects to be considered are -              

• The Size of the Pharmaceutical products
• The Specifications of the product
• The Quality of the product
• The choice of deploying Oxygen absorber packets ensures protection from the storage until the delivery and usage.

Since Pharmaceutical products are mainly drugs that are chemically synthesized to cure the immunological diseases, they are also very expensive and need to be properly packaged to ensure the efficiency of the drug. Hence, these Oxygen scavengers are playing a crucial role in protecting the quality of the Pharmaceutical products and ensuring the safe delivery after manufacturing to till the usage.

Pharmaceutical Microbiology Resources

Combioxin Announces an Oral Presentation on CAL02 clinical results

Combioxin SA, a clinical-stage biotechnology company focused on the development of innovative treatments for severe and resistant infections, announced today that first-in-human clinical results with CAL02 in severe pneumonia patients in ICU was presented during the ESICM’s annual congress, LIVES 2018, taking place October 20-24, 2018 in Paris, France. A recording is available:

Presentation details were as follows:

• Session: Management of patients with sepsis
• Title: Adjunctive intravenous anti-toxin treatment with CAL02 in severe acute communityacquired pneumonia due to Streptococcus pneumoniae.  A first-in-man, multicentre, double-blind, placebo-controlled study
• Presenter: Pierre-François Laterre, Cliniques universitaires Saint-Luc, Université catholique de Louvain (UCL), Brussels, Belgium Date: Wednesday, October 24, 2018 Time: 10:10 AM Location: Barcelona Hall, Palais des Congrès, Paris, France  Presentation number: 0995

CAL02 is a novel liposomal agent that acts as a toxin-trap by mimicking microdomains used as cellular docking stations by various bacterial toxins which prompt inflammatory bursts, cause organ damages, favor invasiveness, impede immune defenses, and are also involved in mechanisms of resistance. CAL02 is designed to protect against these deleterious reactions, allowing a faster resolution of organ dysfunction and protecting immune responses. CAL02 is active against toxins produced by major pathogens responsible for common and severe infections including those caused by drug-resistant pathogens.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Biophotonics Industry Expanding with New Innovations and Strategies

Humans have always been curious about the power and significance of light. This curiosity is evident in ancient religious texts, paintings, literary works, and much more. In the world of light-based technology, photons are the key elementary particles. And the branch of science that deals with the generation, detection, and control of photons for carrying out several functions such as processing data and measuring changes in physical parameters is called photonics. Photonics finds applications in a wide range of disciplines and one of them is biology and medicine. This field of photonics that deals with the interaction of light and a biological substance is called biophotonics, which is extensively used in life science research and biomedical diagnosis, therapy, imaging, surgery, and more.

A guest post by Sharad Singh

The market for biophotonics is witnessing a tremendous progress in recent years. The market growth can be attributed to the emergence of nanotechnology, development in biosensors, rising incidence of chronic diseases, growing government initiatives, and the availability of funds for research and development in biophotonics. The research firm Allied Market Research states that the global biophotonics market size is anticipated to accrue a sum of $63.1 billion by 2022, thereby growing at a CAGR of 10.4% during the forecast period, 2016-2022.

Companies and organizations in the biophotonics space are aiming to grab a greater market share and survive the competition by bringing innovations as well as adopting strategies such as partnerships and mergers and acquisitions (M&As). In October ‘18, Gooch & Housego, a photonics technology company acquired Integrated Technologies Ltd. (ITL), an Ashford-based manufacturing company with the aim of expanding its presence in the life and health sciences space. The University of St. Andrews recently developed a low-damage optical technique that is said to transform the world of biomedicine.

Gooch & Housego Buys Integrated Technologies

Gooch & Housego recently completed the purchase of ITL. The latter offers full product development, design, manufacturing, and after-sales service for the commercialization of medical diagnostic, electromechanical and laboratory instruments. The aim of the deal is to extend Gooch & Housego’s presence in the life and health sciences domain and the allow its entry into system-based products. Based in England, Gooch & Housego is a photonics technology company that researches, designs, engineers, and manufactures advanced photonic systems, components, and instrumentation for sectors such as life sciences, scientific research, and more.

A Ray of Hope for Biomedicine

The new optical imaging technique was discovered by the team of researchers at the University of St. Andrews in collaboration with that of the Centre for Dynamic Imaging, a laboratory within the Institute. The research which was published in Optics Letters on 1st November ’18 reveals that while the use of light technology for assessing biomedical diseases is witnessing a major transformation, the light to image can cause injury to delicate biological samples. Light-sheet fluorescence microscopy is a geometry which enables high-resolution imaging with less optical damage. This is because it illuminates a sample with a thin sheet of light. With this, other areas of the sample are prevented from unnecessary light exposure. The team at the University explored how to examine samples in this geometry using longer wavelengths of illumination. They used three units of optical energy (photons) to excite fluorescent labels in the sample.  This led to less scattering of light and greater penetration of light into the sample. Adrià Escobet-Montalbán, lead author of the study said, “The use of Bessel beams in three-photon light-sheet fluorescence microscopy will make it possible to image large samples with high resolution which is crucial for biomedical and neuroscience research.”

The potential of biophotonics is huge due to its ability to drive and shape a fast-growing market of the future. However, to stay ahead of the competition, companies and lawmakers must enhance the cooperation between researchers, doctors, and companies. Moreover, novel strategies are required to increase the commercialization of promising biophotonic innovations.

Pharmaceutical Microbiology Resources

Hot Read: GMP in Practice

The fifth edition of the PDA/DHI book, GMP in Practice: Regulatory Expectationsfor the Pharmaceutical Industry has been published. The PDA Letter interviewed authors Tim Sandle and James Vesper about this bestselling book, which can be purchased in the PDA Bookstore.

PDA Letter: Why do you think this book has consistently been a bestseller?

Sandle: There is nothing else out there that reviews the major GMPs in this way—breaking GMPs down into the most important areas, and then comparing the various clauses. This makes the book a must for those who are regularly inspected by more than one agency or wish to operate in different regions. Without this book, the task anyone must face in meeting these challenges is enormous.

Vesper, J. and Sandle, T. (2018) Hot Read: GMP in Practice, PDA Letter, Vol. LIV, No. 9, pp35-37

See PDA: https://www.pda.org/pda-letter-portal/archives/full-article/hot-read-gmp-in-practice

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Recent Developments And Future Of Single-Use Bioprocessing Materials Market

Increasing inclination toward the use of high-grade polymer materials in the construction of single-use bioprocessing materials and development of advanced materials that can provide integral strength to the single-use bioprocessing products have boosted the growth of the single-use bioprocessing materials market. According to a research firm, Allied Market Research, in 2016, the single-use bioprocessing materials market was valued at $2.8 billion and is expected to register the compound annual growth rate (CAGR) of 18.7% during period 2017–2023.

A guest post by Srushti Helwande.

Immense demand for single-use bioprocessing materials has led to numerous mergers & acquisitions and partnerships. In fact, partnerships are regarded as the most efficient way to expand business. Recently, Emergent BioSolutions, the U.S.-based multinational specialty biopharmaceutical company, extended its partnership with vendor ABEC to add a dual plant in Maryland, U.S. Similarly, Chinese company, Wego Pharmaceuticals, decided to collaborate with GE Healthcare to manufacture single-use consumables. Such developments have become necessary to cater to the demand-supply equation in the market.

Collaborations to boost the efficiency

A healthcare technology supplier in China, Wego Pharmaceuticals, recently announced its collaboration with GE healthcare, to manufacture single-use consumables for bioprocessing. In addition, the first product is expected to hit the Chinese market by the end of November 2018.

Single-use bioprocessing materials coupled with its efficiency and speed are expected to meet with China’s broader healthcare goals. Olivier Loeillot, General Manager of bioprocess at GE Healthcare Life Sciences, stated, “This partnership signifies how China continues to maintain its leading position in the adoption of novel single-use biomanufacturing solutions. GE and Wego Pharmaceuticals have signed a long-term partnership agreement to expand its supply outside of China as the Asia-Pacific market offers lucrative opportunities.”

Similarly, Emergent BioSolutions also extended its tie-up with ABEC to make an addition of a dual purpose to Emergent’s facility at Baltimore, Maryland. Moreover, to seal the deal, ABEC has shipped a custom-made CSR (Custom Single Run) single-use system, which would be used for mammalian cell culture and large-scale microbial fermentation. A year ago, Emergent installed a 4,000 L single-use bioreactor from ABEC, the largest bioreactor available in the market.

Cooper-Curcio, ABEC’s spokesperson, stated, “ABEC’s custom single run systems improve our client’s flexibility, productivity, and economies of scale and the market leaders are realizing these benefits.”

Future of single-use bioprocessing

Technological advancements and dire need for upgraded efficiency have tremendous potential to create novel benefits of single-use bioprocessing. It is expected that the future in single-use bioprocessing would be filled with big data and machine learning. The benefits of automation are self-explanatory, but till now, we have only scratched a surface when it comes dealing with the humongous data generated by these automated systems. Thus, the applications of big data in single-use bioprocessing are still in nascent stage.

Apart from real-time controlling and monitoring, automated solutions improve the ability to analyze historical operations, processes, and performance data, which can result in several useful outcomes, including controlling outcomes to optimize product yield. The next big thing in the single-use bioprocessing materials market will be the incorporation of machine learning based on the big data. For instance, GE Healthcare recently developed a scale-agnostic machine learning infrastructure to deal with yield-efficiencies in bioprocess production facilities. The company has used advanced artificial intelligence algorithms to create process-parameter values that are specially designed to maximize the yield of every production run.

For the last few years, it has become clear that majority of the shareholdings are funded to develop innovative single-use bioprocessing materials. However, the biggest challenge today is for those companies that manufacture the single-use bioprocessing products using downstream process and need to achieve the results experienced during the upstream process. Once the systems are able to balance the equation, the market players would witness lucrative opportunities in the future.

Pharmaceutical Microbiology Resources

Gram-negative bacteria increase mortality

Alterations to the respiratory microbiome have been identified as a predisposing factor of interstitial lung diseases (ILD). In a new study, researchers studied the influence of bacterial virulence on clinical outcomes patients hospitalized with ILD patients. The authors found that the use of immunosuppressive medications or antifibrotics had no influence on the outcomes including development of resistant pathogens in patients.

Researchers conducted a retrospective analysis of 472 patients with ILD who were admitted to a large tertiary care academic center from Jan. 1st, 2010, to Dec. 31st, 2016. Patient data were extracted from electronic records using ICD-9 and ICD-10 billing codes for various ILD. The majority of the patients had either pulmonary fibrosis or sarcoidosis.

One hundred and seventy respiratory cultures were collected in this population. The majority of the respiratory isolates were gram-negative pathogens (39 percent Pseudomonas and 18 percent other gram-negative organisms); 27 percent were methicillin-resistant staphylococcus aureus (MRSA). Patients infected with gram-negative organisms (other than Pseudomonas) and MRSA had the highest 30-day mortality (39 percent and 32 percent respectively) compared with lower mortality for those infected with Pseudomonas and other gram positive organisms (7 percent and 14 percent respectively). Patients infected with gram-negative organisms other than Pseudomonas also had higher rates of vasopressin administration compared with those infected with other organisms. Rates of ICU admission also differed according to organism that was cultured. These associations persisted even after adjustment for the other variables including type of ILD, age, gender, comorbid conditions and smoking history. There was no association between the use of immunosuppressant medications or antifibrotics and the development of resistant pathogens.

See:

Hira Iftikhar, Chengda Zhang, Girish Balachandran Nair. Role of Respiratory Pathogens in Disease Outcomes in Hospitalized Patients With Interstitial Lung Disease. Chest, 2018; 154 (4): 445A DOI: 10.1016/j.chest.2018.08.405

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

The Earth Microbiome Project

The Earth Microbiome Project is a systematic attempt to characterize global microbial taxonomic and functional diversity for the benefit of the planet and humankind.

The Earth Microbiome Project (EMP) is a massively collaborative effort to characterize microbial life on this planet. We use DNA sequencing and mass spectrometry of crowd-sourced samples to understand patterns in microbial ecology across the biomes and habitats of our planet. The EMP is a comprehensive example of open science, leveraging a collaborative network of 500+ investigators, supporting pre-publication data sharing, and crowdsourcing data analysis to enable universal principles to be explored. The standardized collection, curation, and analysis are enabling a robust interpretation of ecological trends.

The Vision: Constructing the Microbial Map for Planet Earth

The EMP was founded in 2010 as a massive crowd-sourced effort to analyze microbial communities across the globe. The general premise was to examine microbial communities from their own perspective. Hence we proposed to characterize the Earth by environmental parameter space into different biomes and then explore these using samples drawn from researchers across the globe. We set out to analyze 200,000 samples from these communities using amplicon sequencing, metagenomics, and metabolomics to produce a global Gene Atlas describing protein space, environmental metabolic models for each biome, approximately 500,000 reconstructed microbial genomes, a global metabolic model, and a data-analysis portal for visualization of processed information.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology