Below is a quick overview of the full article.

In the summer of 2020, the UK’s Department of Health and Social Care (DHSC) launched Operation Moonshot to support innovative SARS-CoV-2 diagnostic approaches. This collaboration between academia, industry, and the NHS aimed to develop an LC-MS/MS-based test for detecting low levels of SARS-CoV-2 tryptic peptides. Surprisingly, the project succeeded in creating a viable test within just five months.

Rachel Carling, Director of Newborn Screening and Clinical Lead for Biomedical Sciences at Synnovis, who led the labs in this initiative, shares key lessons from Operation Moonshot.

1. Collaboration was Crucial: Operation Moonshot’s success relied on the synergy between academia, industry, and the NHS. Academia rapidly developed a specialized mass spectrometry method, industry provided advanced technology and support, and the NHS optimized and validated the method for UKAS accreditation.
2. Choosing Mass Spec: Despite initial concerns about mass spectrometry’s sensitivity compared to PCR, the team favored it for its ability to detect SARS-CoV-2 peptides while maintaining high throughput and adaptability to handle variants.
3. Overcoming Challenges: Balancing sensitivity and speed during analysis was a challenge, but the introduction of immunocapture reagents and the Andrew+ pipetting robot streamlined the process.
4. Key Lessons: Operation Moonshot emphasized the value of collaboration, advanced technology, automation, and dedicated development time. Post-pandemic, the “triplex” approach involving academia, industry, and the NHS should continue. Additionally, investing in mass spectrometry and pre-analysis within the NHS offers multiple benefits.
5. Preparing for Future Pandemics: The experience gained from Operation Moonshot has improved preparedness for future pandemics. Lessons learned include better management of rapidly changing plans and effective communication.
6. The Future of Clinical Testing: Operation Moonshot has expanded the possibilities of routine clinical labs, showcasing mass spectrometry’s potential for peptide analysis. This legacy holds promise for numerous clinical testing advancements.

In conclusion, Operation Moonshot’s swift development of an LC-MS/MS-based COVID-19 test underscores the power of collaboration, mass spectrometry’s potential in diagnostics, and the importance of healthcare infrastructure investment for pandemic preparedness. These lessons may shape the future of clinical testing and global health readiness.

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As scientific innovation continues to rapidly advance, enabling scientists with equally innovative tools is a must. Traditional laboratory operations can be limited by unconnected devices and software platforms, requiring technicians to manually prepare samples, enter data, transfer samples, and trigger analytical runs. These manual touchpoints limit lab productivity, restrict traceability, and introduce opportunities for human error.

Through this collaboration, scientists will now be able to use the Waters Andrew+ Pipetting Robot to fully automate routine sample preparation protocols, from simple to complex. Powered by Green Button Go scheduling software from Biosero, the automated workflow can incorporate a variety of robotic arms, laboratory workstations, mobile robots, and other tools to move samples from start to finish for important analytical analyses.

To learn more about this exciting announcement:

• Meet Green Button Go at biosero.com/greenbuttongo
• Meet the Andrew+ Pipetting Robot at waters.com/andrewplus

About Biosero

Biosero, a member of the BICO group, develops science-centric software and laboratory automation solutions that enable researchers to orchestrate their discoveries at every stage. Biosero’s Green Button Go^® Scheduler software and integration services match laboratory automation to science, creating a cohesive technology ecosystem that accelerates operations and increases productivity. Additionally, Green Button Go Orchestrator applications provide an end-to-end laboratory management solution, directing workflows and operations in life science, biotechnology, pharmaceutical, and diagnostic research. Biosero is passionate about partnering with organizations dedicated to enhancing life by addressing the world’s most significant needs. For more information, please visit www.biosero.com.

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Waters launched its new PeptideWorks Tryptic Protein Digestion Kits to provide biopharma scientists with a comprehensive, automatable solution for rapid sample preparation for peptide mapping. By reducing missed cleavages and autolysis peaks, which can complicate data processing, the kits bolster digestion performance and provide exquisite baselines free from
noise. The launch of PeptideWorks Tryptic Protein Digestion Kits completes Waters’ end-to-end solution for peptide mapping. PeptideWorks Tryptic Protein Digestion Kits deliver automatable, high efficiency, and reproducible peptide mapping: – Quick sample preparation in under 2.5 hours (vs. standard “home-brew” methods of 6-8 hours), which is 4x faster than average home-brew methods allowing quick and confident decisions during critical data analysis for protein characterization. “Home-brew” is the most common protocol for protein digestion, which includes sourcing reagents individualized from various manufacturers, which often result in long and complicated development times.

– With clean baselines that minimize the number of unmatched peaks, such as under- digestion (78% reduction in missed cleavages vs. leading competitor), over-digestion (non- specific cleavages), or digestion of the enzyme itself (98% reduction in contaminating autolysis peaks vs. leading competitor).

– Achieve improved and automatable desalting with new fit-for-purpose Sep-PakTM SEC Desalting Cartridges for reproducible and efficient salt removal with ≥ 80% protein recoveries.

PeptideWorks Tryptic Protein Digestion Kits alleviate the cumbersome steps of desalting (extracting salt content and denaturant) by automating both the desalting step and the entire peptide mapping sample preparation with one comprehensive kit for manual or automated workflows and eliminates the need to source multiple reagents. It is fully automated to provide robust, reproducible results, making for easier method transfer from lab to lab. PeptideWorks Tryptic Protein Digestion Kits offer scientists working in discovery or development and characterization within small to large biopharma companies, CROs, and CDMOs, a complete peptide mapping workflow. Complete kits cover sample preparation for the separation and detection on the Waters BioAccordTM System with ACQUITYTM Premier LC System coupled with data processing on waters_connectTM Software with Peptide Mapping and Peptide MAM apps. The kit offers five flexible formats to run up to 96 samples:
• (3) kits for denaturation, reduction, alkylation, desalting, and digestion, which includes starter kits (including ACQUITY Premier Peptide CSHTM C18 Column) and refill kits.
• (2) kits without denaturation, reduction, and alkylation, which includes starter kits and refill kits with desalting and digestion.

The new kits address the challenge of long, irreproducible sample preparation of peptide mapping across all protein digestion sample preparation characterization workflows with highdigestion efficiency within biopharmaceutical R&D. Additional Resources:
• Learn more at waters.com
• Read our Application Note
• Read our Quick Start Guide
• See our Infographic
• Connect with Waters via Twitter, Facebook, and LinkedIn

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“Reproducing the results of research studies is a common challenge across scientic disciplines, and SPE techniques that are error-prone and dicult to repeat are a signicant cause,” said Erin Chambers, Vice President, Chemistry, Waters Corporation. “The Andrew+ Pipetting Robot with Extraction+ Connected Device and OneLab Software helps analytical laboratories improve reproducibility while giving bench chemists up to four hours back that would 1 otherwise be spent on manual pipetting and sample extraction.”

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Since the start-of the Covid-19 pandemic, there has been an enormous surge in demand for Covid-19 testing, which has taken us back to an interview with Michela Savoldi-Boles, Chief Technology Officer of Bioside Diagnostics, earlier this year, who talked about the challenges of rapid scale-up during an extremely challenging time in the Lombardy region of Italy, and on Covid-19 testing accelerated with Andrew+.. read on..

Q: Please could you tell us a little bit about Bioside Diagnostics and your role there

A: Bioside is a young, Italian Company, operating in molecular biology and microbiology.  We have our HQ in Lombardy in the North of Italy.  We are located in a biotechnology centre, and have benefitted greatly from collaborations and networking due to the number of research centres, start-ups and other institutes, especially during the early days of our company.  I am Chief Technology Officer of Bioside and I am a biologist, responsible for the development and manufacturing of the Bioside kits.  Our Company produced and developed molecular biology kits and microbiology kits especially in the environmental and food fields, and this year we also started to produce kits for the clinical and diagnostic areas.  We have been on the market for 5 years and during this time had a lot of collaboration with major players such as Thermo Fisher Scientific.. actually we produce kits for Thermo and we have other distributors on the market because we are now approaching the global market for the first time.

We have been performing clinical tests in our laboratory since March 2020.  We are also producing the test kits but in order to give support to our region especially, because Lombardy was the first region to be affected in Italy, our region needs to have more laboratories in order to be able to do the number of tests required, so we also perform the required analytical work.  It is a temporary situation in order to give our support to the state.

Q: I understand that Bioside is developing a diagnostic test for COVID-19.  Please could you tell us a little bit about the test and how it works.

A: We produced kits in molecular biology with a proprietary technology , ensuring that they are stable at room temperature and are ready to be used by the customer.  The technology is based upon Real Time PCR and the production technology is proprietary and patented by Bioside.  The innovation for our customers is that for them it is very easy to use because all the reagents are pre-dosed and dispensed direct into the plastics so the customer needs only to put the RNA or DNA into our test tubes and then perform the analysis, so it is very simple to use.  The reagents are stored at room temperature for both storage and for transport.  We also have a technology for processing both the RNA and the DNA so when COVID-19 occurred we had the perfect combination of technologies in order to develop a kit for SARS COVID-19.  It was very difficult to develop these kits in February because there was has been limited information about the virus and the situation very different from our standard practice. A further innovation is the fact that our kits also detect the presence of different mutations of SAR COVID-19, in order to give the best technical specification of the product for our customers.

Q: What are the key challenges in developing the test and how has working in lockdown, in Italy, affected that?

A: It was very difficult as during the lockdown, we needed to be open so that we could continue to operate as well as to produce kits. We provide diagnostics tests for application in both hygiene assessment and the clinic.  During lockdown, the test results were urgently required but in order to respect social distancing we needed to deliver faster results with less staff.  We needed to operate from 7am to 7pm every day of the week.  We had problems with some of our suppliers as some were COVID contaminated, and we needed to carefully check materials and cells received in order to verify that the virus was not present.  This was especially challenging as the situation changed each week.  For example, regulations kept changing, and when some of our staff fell ill, we needed to replace them at short notice.

Q: How do you see our automation (Andrew+) supporting your development work?

A: It was very important because during the rapidly evolving situation we needed to upgrade our production capacity from 100 tests to 1000 tests per day so we needed to automate some of our processes, especially those involving liquid handling.  Achieving this whilst needing to reduce staff was very difficult.

We have had experience with other automation platforms and found that, in some cases, the automation is not flexible.  We chose Andrew Alliance as the Andrew+ system was more flexible than others and we saw it better fitted our needs, especially given the circumstances where we couldn’t predict what might happen tomorrow. Its highly flexible workspace enabled us to quickly adapt our workflow.  Covid-19 testing accelerated with Andrew+.  This is why we chose Andrew+. 

Andrew+ liquid handling robots being used under laminar flow hoods.

The set-up of the robot was very rapid and very simple.. we have experience of other instruments that need days to do the installation and a lot of technical support.. instead with Andrew+, the instrument was ‘ready to go’ and just needed 2 hours of remote support in order to complete installation and to have it up and fully working..

..the ability of the Andrew personnel during the installation was very punctual and rapid because they are available by phone, by internet, by email.. we felt very supported by Andrew Alliance during the installation..

Q: What aspects of both Andrew+ and the OneLab software do you see most beneficial.. and why?

A: The flexibility during the program and execution and running of protocol and also the flexibility in the use of different Dominos as well as the number of Dominos.. in order to change the application of Andrew+, you just need to swap Dominos. Covid-19 testing accelerated with Andrew+.

Our test is now on the market (since May).. it requires the correct certification ‘marks’ in order to permit its use in hospitals.  We are working on gaining European authorisation for use in an emergency.. now we are distributing the tests to hospitals as well as for laboratories involved in environmental and clinical testing.

Learn more at www.andrewalliance.com

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The next-generation pipetting technology enhances reproducibility and simplifies complex and time-consuming manual workflows

SANTA CLARA, California, Oct. 26, 2020 /PRNewswire/ — Based on its recent analysis of the North American pipetting robot market for life sciences, Frost & Sullivan recognizes Andrew Alliance, a Waters Company, with the 2020 North American Product Leadership Award. Andrew Alliance’s liquid handling robot, Andrew+, integrates robotic mechanisms with conventional laboratory pipettes to improve the repeatability of liquid handling. These easy-to-use robots and connected devices allow scientists and laboratory technicians to achieve repeatability, performance, and efficiency in their experiments. Andrew Alliance is one of the few companies worldwide to manufacture its products in an eco-friendly environment and use carbon-neutral electrical power.

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Pathogen testing is of major importance to the food industry as there are 31 known bacteria and virus causing pathogens, and more unidentified agents, that cause foodborne illnesses. The elimination of these disease-causing pathogens is a desire for the entire food industry. Food recalls due to pathogen contamination can be disastrous and expensive for all involved. Full traceability and cloud-sharing protocols minimize the risk of erroneous data, which can be a cause of this.

Foodborne illnesses are a major concern for the food industry. The Centers for Disease Control (CDC) estimates that about 1 in 6 people in America or 48 million people are infected with a foodborne pathogen each year. Of those 48 million, 128,000 are hospitalized and 3,000 ultimately die.

Testing is done to reduce, and ultimately eliminate foodborne illnesses. It is a process implemented in every step of food production to ensure sanitation and food safety. The most common foodborne illnesses that pathogen testing is concerned with are salmonella, listeria, and E. coli. Pathogen testing can be done using conventional cell culture standards, or more recent molecular biology techniques based upon PCR.

The incidence of foodborne diseases has increased over the years and resulted in major public health problem globally. Foodborne pathogens can be found in various foods and it is important to detect them to provide safe food supply and to prevent foodborne diseases. These qualitative proficiency tests focus on the detection of the pathogens specified. Proficiency tests aim to improve a laboratory’s detection ability through identification of areas of improvement from which to provide highly credible, repeatable results.

The Importance of Proficiency Testing in Assuring Analytical Laboratories

Proficiency testing has increased in food microbiology laboratories in response to various factors: ISO 17025 accreditation increases, regulatory focus, customer requirements, internal quality requirements and an increase in validation and verification activities.

It has been further fuelled by data highlighting causes of inadequate detection of micro-organisms in food.  The causes are broken out in the figure below.

Causes of inadequate quantification of micro-organisms (Massih et al, 2015)

With regard to ‘methods’, laboratories are advised to use their routine protocols for the analysis of the PT samples and the variety of the methods used accounted for 15% of the outliers.

When methods are based on different principles (e.g. different protocols, media, temperatures or confirmation techniques), the performances in terms of productivity or precision are not always comparable.

Proficiency Testing use in Food Testing Laboratories

Proficiency testing (PT) is widely used in the food testing industry as a way to verify that an individual laboratory is capable of performing a given analytical method, and to detect possible issues.  A PT scheme consists in an inter‐laboratory comparison, based on the analysis of identical samples by different laboratories. The analytical results obtained by the participants are collected by the PT provider and statistically compared to detect false or outlying results. It is then the responsibility of the laboratory to determine the possible causes of the observed errors and to implement corrective actions.

Since 2005, the ISO 17025 standard for the accreditation of laboratories requires regular participation to PT, if available, as a quality control tool (Anonymous, 2005). This process is meant to instigate continuous improvement of the laboratories, as each outlier should be addressed by the laboratory and followed by appropriate corrective actions.

The first PT programmes had been conducted in 1946 in the clinical field, with the aim of demonstrating the reliability of the laboratory analytical results. At the beginning, the participants’ analytical performances were globally poor, revealing high incoherency between laboratories and highlighting the need for external harmonization.

The field of food microbiology has followed the trend of the medical sector, driven by a need for reliable analyses to ensure food safety. Supported by governmental initiatives, numerous food microbiology PT schemes have emerged worldwide in the last 30 years.

Today, the European Proficiency Test Information Service (EPTIS) database lists no less than 120 PT schemes worldwide in the field of food microbiology (www.eptis.bam.de, 2015).

PT schemes represent a unique observation post to study the performances of routine laboratories, to follow the evolution of these performances in time, and to better understand and potentially eliminate the causes of unsatisfactory analytical results. This process is also educational: the interpretation of the PT results can help to highlight the main causes of errors in food microbiology analyses and to suggest areas of improvement to the laboratories.

Full traceability and cloud-sharing protocols minimize the risk of failing a proficiency test

Ensuring full traceability of each step conducted in an analytical workflow can ensure compliance with established regulatory practice as well as troubleshooting any sources of error.  It can also ensure that proficiency testing is that much easier to conduct between ‘reference laboratory’ and the laboratory being evaluated.  Moreover, the ability to readily share protocols between laboratories, via the cloud, mitigates protocol misinterpretation as a source of error.  Learn about how OneLab enables this, here. Full traceability and cloud-sharing protocols minimize the risk of failing a proficiency test

Massih et al.,  Analytical performances of food microbiology laboratories – critical analysis of 7 years of proficiency testing results,  J. Appl. Microbiol., 24 November 2015

Learn more at www.andrewalliance.com

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“Not responding is a response – we are equally responsible for what we don’t do.”  (Jonathan Safran Foer, 2011).

Life-saving therapeutics and vaccines undergo a sophisticated array of both in-vitro, and later in the drug development process, in-vivo testing.  Different animal models are used, with the aid of establishing drug safety, as well as parameters of use in human beings.

The importance of ADME Tox Testing

DMPK, or Drug Metabolism and Pharmacokinetics, is an important part of studies often referred to as ADME (Absorption, Distribution, Metabolism, and Elimination).

• Absorption (how much and how fast, often referred to as the absorbed fraction or bioavailability)
• Distribution (where the drug is distributed, how fast and how extensive)
• Metabolism (how fast, what mechanism/route, what metabolite is formed, and whether they are
• active or toxic)
• Elimination (how fast, which route).

In the drug discovery process, early in vitro ADME screening and in vivo PK profiling provide a basis for choosing new molecular entities (NMEs) and lead compounds that have desirable drug metabolism, PK or safety profiles, necessary for drug candidate selection (CS) and late‐stage preclinical and clinical development. The ADME properties of a drug allow the drug developer to understand the safety and efficacy data required for regulatory approval.

Toxicology tests are often a part of this process, yielding the acronym ADMET.

Today, such studies are performed both in vitro and in vivo, and have led to more standardised procedures across the pharmaceutical industry.

Importance of the 3Rs in Drug Discovery

There has been understandable concern over the ways in which animals have been used and treated as part of this process.  As such, the principles of the 3Rs (Replacement, Reduction and Refinement) were developed over 50 years ago providing a framework for performing more humane animal research.  Since then they have been embedded in national and international legislation and regulations on the use of animals in scientific procedures, as well as in the policies of organisations that fund or conduct animal research.  Opinion polls of public attitudes consistently show that support for animal research is conditional on the 3Rs being put into practice.

Increased effort has gone into the development of so called ‘alternative’ methods over the last decade.

Replacement and Refinement of Animal Models

Replacement refers to technologies or approaches which directly replace or avoid the use of animals in experiments where they would otherwise have been used, for example the use of methods employing human embryonic stem cells as alternative ways of conducting ADMET studies.  Refinement refers to methods that minimise the pain, suffering, distress or lasting harm that may be experienced by research animals, and which improve their welfare. Refinement applies to all aspects of animal use, from their housing and husbandry to the scientific procedures performed on them.

By contrast, reduction refers to methods that minimise the number of animals used per experiment or study consistent with the scientific aims. It is essential for reduction that studies with animals are appropriately designed and analysed to ensure robust and reproducible findings.

Funders have taken a stronger position regarding the use of animal testing in founded research.  The European Union’s Horizon 2020 program, for example, forbids use of animal models in its funded research, rather advocating methods validated through organisations such as the European Centre for the Validation of alternative methods (ECVAM), based at the Joint Research Centre in Ispra, Italy.

Reducing the need for animal models by minimising unnecessary waste

Reduction also includes methods which allow the information gathered per animal in an experiment to be maximised in order to reduce the use of additional animals. Examples of this include the micro-sampling of blood, where small volumes enable repeat sampling in the same animal. In these scenarios, it is important to ensure that reducing the number of animals used is balanced against any additional suffering that might be caused by their repeated use.  Sharing data and resources (e.g. animals, tissues and equipment) between research groups and organisations can also contribute to reduction.

It’s still about the ‘reproducibility crisis’!

Regarding ‘reduction’ much emphasis is placed on the importance of minimising the number of animals used in a study.  Over the past several years, it’s become increasingly apparent that many lab studies, especially in the life sciences, are not reproducible. As a result, many putative drug targets or diagnostic biomarkers can’t be validated. Some estimates suggest that more than 50% of all published life sciences research is irreproducible, and some indicate that the figure might be even higher.  The problem flew below the radar for years. A 2012 comment in Nature by C. Glenn Begley, a former vice president at Amgen, and Lee M. Ellis, an oncologist at the University of Texas M. D. Anderson Cancer Center, drew attention to the problem. They described Amgen scientists’ attempts to replicate the key findings in 53 “landmark” fundamental cancer studies that claimed to identify potential new drug targets. They were able to replicate the findings in only 11% of the cases.

This ‘concern’ has not dissipated but has triggered a number of subsequent studies aimed at identifying the reasons for such has high levels of irreproducibility.  There a number of causes, which vary from the deliberate falsification of research, with increased pressure being brought to bear on the peer review process, to the tools we use in the laboratory and the ways in which those can contribute to erroneous data.  These include, but are not limited to, the means by which powders (e.g. precision weighing scale) and liquids (e.g. pipettes) are handled, mixed and transferred; as well as the way in which one research group might interpret and repeat the work of another.  This latter point might seem odd when considered alongside tools but bear in mind that the way in which the tools are used depends upon an accurate description and interpretation of the protocol used, an important area of research and development in its own right.

In order to respect the 3Rs, researchers must constantly strive to ensure that the latest techniques tools are fully used.  Pipetting is one such cause of error, as is the incorrect interpretation and replication of an experiment protocol. 

Supporting the 3Rs with ‘the Connected Lab’

It is important to reduce unnecessary replication of studies due to such errors if the means exist to mitigate the cause.  Andrew Alliance developed its OneLab cloud-native software with the intent of minimizing error in setting up pipettes on their Andrew+ pipetting robot or Pipette+ smart pipetting system (they are programmed remotely), and ensuring full experiment traceability.  Moreover, it also ensures accurate sharing of protocols between different research groups, alongside the even greater benefit of a ‘connected laboratory’ where the implications of one experimental action (e.g. weighing) are able to inform other experimental actions (e.g. pipetting) or vice versa.  Put another way, it is about getting smarter in the way we do things in the laboratory, including minimizing waste.

Learn more at www.andrewalliance.com

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