From sending money to friends with a mobile payment app to tracking a package delivery door-to-door, digital technology is ubiquitous in the consumer world—so much that consumers expect it. But the technology advances that create a seamless consumer experience haven’t fully made their way into the laboratory environment.

In a 2020 Accenture report surveying 128 life sciences industry leaders, 40% replied that they had not yet applied digital transformation efforts to R&D or quality control (QC) labs, and 37% more were still in pilot mode. The same survey revealed that 70% of respondents who have scaled up or widely adopted digital transformation reported achieving or exceeding anticipated business value (1). Although the benefits of digital transformation are clear, there is much progress to be made. 

Making that progress is critical. Labs are increasingly challenged to operate more effectively. From executives who want to ensure labs operate efficiently and sustainably, to investor expectations around speed-to-market, to patients’ need for affordable therapies, the more inefficiencies labs can remove from their processes, the better they can meet all the demands being placed on them.

Additional drive for digitalization comes from the bench itself. On average, scientists spend as much as 42% of their time handling noncore, administrative tasks, including tasks such as procurement and inventory and equipment management (2). Every minute a scientist spends searching storerooms for a misplaced consumable is a minute that their focus is taken away from discovery and innovation.

In addition, labs are also being challenged by larger trends, such as supply chain issues and sustainability. Inflation is compounding already-increasing costs for materials used to make complex therapies. Shifts in the workforce—whether pressure to retain workers or labs moving to hybrid or virtual teams—are also straining lab resources. These changes make it more incumbent on labs to find ways to leverage technology to deliver on tasks that do not necessarily need to be handled by humans. Likewise, increased globalization—and the regulatory and logistical considerations it brings—challenges labs to operate with seamless transparency.

In the automated manufacturing world, production machines use sensors and controls to efficiently capture, filter, and package data. The data is then transferred via gateways to cloud-based analytical platforms that generate actionable data in real time, helping to create a real-world “factory of the future”. As a result, automated manufacturers can drive efficiencies, decrease time-to-market, and meet their customers’ evolving needs.

Yet in the lab environment, fragmentation in information and process flows persists. Experimentation platforms generate an ocean of data and results quickly and efficiently. Yet the data collected are not necessarily easy to connect and integrate in a smooth way. For example, scientists prepare and document their protocols differently on a wide range of tools, from paper to spreadsheets to electronic lab notebooks, and use various tools, such as literature or instrumentation, during any one stage of the process. However, these tools often lack interoperability or the capacity to exchange and utilize data between users.

This lack of visibility constitutes a core challenge for labs. Researchers and lab managers may not be able to access timely information to identify trends or adapt to evolving situations, leading to increased costs, waste, and time to market. This can be attributed to several factors:

: whether a rarely used product is suddenly needed and has not been reordered, or stock of high-demand products is depleted simultaneously by multiple research teams, this situation can interfere with or cancel valuable research work.

Overorders and slow inventory turnover: to protect themselves from stock-outs and supply chain disruptions, many labs overorder and maintain excess supplies of products that are stored for months or longer until they expire and require disposal.

Duplication of work: teams in other labs may have been running the same protocol but without visibility, resulting in other scientists not having access to that critical data. What’s more, they may have missed out on the opportunity to change the variations being run. This slows productivity and leads to missed data opportunities.

Supporting an integrated digital lab: closing the gab between source and scientist

Digital transformation that includes intelligent integration of data systems can significantly improve lab workflows, strengthen the supply chain, and give researchers more time to focus on science. Labs are already making some progress in one key area: compiling instrumentation data into one system or data warehouse. By collecting these data in a single accessible location, scientists can pull valuable instrumentation data as needed.

Labs are also increasingly adoptiing automation. Combining automated technologies with data analysis on what scientists are doing and which protocols they are working on can generate real-time predictive analytics based on prior trends. As a result, a lab no longer needs to wait weeks or months to identify trends or adapt to changing situations. Rather, they can quickly acquire and allocate resources, even across multiple locations, while giving researchers more time to discover and innovate.

The predictive data approach is based on historical data, such as order history, sample history, consumables consumption, and equipment use. The next stage of evolution for labs will be a move toward prescriptive analytics. This approach combines the ability to predict based on past trends with larger factors, such as market trends or supply chain disruptions. The result is a layering of what should be done now to offset what will likely happen in the future. 

Considering some of the world’s largest e-commerce companies, it has been shown that such companies can predict consumer needs before those needs are known to the consumer. In a lab setting, that same type of digital transformation could identify, for example, a disruption in preferred test tube supply—such during the COVID-19 outbreak—and use artificial intelligence (AI) to recommend an available alternative that meets the experiment’s protocols.

Equipment is a crucial example of this, as it can act as a key bottleneck if a lab doesn’t have enough of a specific piece of equipment, or if many of a lab’s researchers want to use a specific piece at the same time. A predictive approach to equipment management starts by looking at historical usage: Are scientists using this equipment more or less frequently? Do they favor certain types? How often does it typically break down?Answers to questions such as these are important for planning capacity and ensuring researchers have access to the tools they need.

In the not-too-distant future, a prescriptive approach in laboratories will expand on the information needed to make recommendations, often with artificial intelligence. A prescriptive platform might, for instance, recommend that a scientist change a filter on a particular mass spectrometer every three months to extend the equipment’s life span from one year to potentially three years.

Along with a shift toward prescriptive analytics, labs can leverage other types of technology to create more opportunities for researchers to focus on science. For example, virtual reality (VR) has the potential to act as a powerful collaboration tool. A scientist could wear a VR lens to see how an experiment should be run without having to be in the same physical space as another scientist. This type of play-by-play immersion could be delivered by a recording of the experiment or in real-time with a scientist in a lab across the globe. The same value could be brought to equipment management, allowing a scientist with VR equipment to work with an off-site equipment technician to fix malfunctioning equipment.

As researchers continue to drive innovations that improve lives for patients around the globe, technology will continue to help enable that discovery. Whether it involves a VR collaboration session with a colleague on the other side of the world or AI that anticipates solutions for supply chain disruptions in vaccine development, digital transformation technologies empower labs and their teams to get treatments to market faster.

Digital Transformation in the Lab: Bridging the Analog Islands in a Digital Ocean

, February 2020.
2. National Science Board, 

Reducing Investigators’ Administrative Workload for Federally Funded Research

Bruce Dembofsky is director, Innovations and Partnerships, and Tola Olorunnisola is vice-president of Innovation, Marketing & Digital; both are at Avantor.

Articles

Features

Integrating digital technologies into lab environments can ease workflow and enhance data capture for researchers.

Lab Digitalization: From Source to Scientist 

With many blockbuster biologic drugs soon to lose patent protection—Humira and Keytruda, among others—the number of biosimilars under development is increasing. In jurisdictions with robust regulatory standards, such as the United States and European Union, the approval pathways for biosimilars, while distinct from the pathway for originator biologics, are rigorous and scientifically appropriate, according to Jeff Yant, executive director of biosimilars operations at Amgen.

These approval pathways require demonstration of biosimilarity between the biosimilar candidate and the approved innovator drug in terms of efficacy, safety, and purity. To meet this requirement, biosimilar developers must evaluate the physiochemical and structural properties of the biosimilar candidates and reference products and conduct clinical studies to compare the safety and efficacy profiles of the products.

Biosimilars must have the same route of administration, the same dosage, and the same side effects profile as the innovator drug, notes Todd Stawicki, global marketing manager for biopharma at SCIEX. Therefore, to develop a biosimilar, it is necessary to fully characterize the reference product so the biosimilar can be built to be highly similar in all of these respects, including the different variants and impurities that are present, adds Susan Darling, senior director of product and market management for CE and Biopharma at SCIEX.

Biosimilarity is first demonstrated with analytical data supporting structural and functional similarity, then through clinical studies assessing immunogenicity and pharmacokinetics (PK), and in some cases pharmacodynamics (PD). Additional comparative clinical studies, says Ricardo Infante, global medical lead for Organon Biosimilars, are conducted between the reference product and the proposed biosimilar to ensure there are no clinically meaningful differences in efficacy and safety.

“The goal of a biosimilar development program is to demonstrate that the candidate biosimilar is highly similar to and has no clinically meaningful differences from its originator/reference product, not to independently establish de novo the safety and efficacy of the biosimilar,” adds Yant.

The array of data the manufacturer of a proposed biosimilar product must generate for the proposed product and the FDA-approved reference product in order to demonstrate biosimilarity include, according to Yant, analytical studies demonstrating that the biological product is highly similar to the reference product, notwithstanding minor differences in clinically inactive components; animal studies, including an assessment of toxicity; and a clinical study or studies sufficient to demonstrate safety, purity, and potency of the proposed biosimilar product in one or more of the indications for which the reference product is licensed.

Yant also emphasizes that no single study or endpoint should be considered “pivotal” in a biosimilar marketing application. Rather the totality of data and information submitted should support the demonstration of biosimilarity (1).

Developing a biosimilar is more nuanced than developing a small-molecule generic product. With small molecules, the API is a single molecule with a highly defined structure and chemical composition. There may be different synthetic routes to producing the compound that could potentially lead to different impurities, but the actual molecule itself will be identical in the branded and generic versions. There are no possible variants to consider.

Like all biologics, Yant notes that biosimilars are produced through an intricate, multistep process using living cells. The molecule is in fact determined by the process, Stawicki stresses. Every step in the process and every change in process conditions affects the nature of the biologic product. “There is a significant change in mentality needed when developing biosimilars vs. generics,” he says, “with the focus shifting to defining and controlling and characterizing the process to make the highly similar product.” There is also a need, Stawicki notes, for biosimilar developers to have a good understanding of how potential changes to the molecule can change side effects.

Complicating this issue is the fact that for most biologics, the majority of details about the production processes for these reference products are not publicly available. “The cell line and manufacturing process of the reference product are proprietary and belong only to the reference product
manufacturer,” says Yant.

As a result, biosimilar developers basically need to start from scratch and use their own processes. “Characterizing the reference molecule, figuring out which cell line to use, and essentially reengineering the manufacturing process is tremendously expensive. For this reason, some of the companies with the most demonstrated success in biosimilars are also developers of novel drugs—they are able to leverage the same expertise, processes, and toolset for both,” Darling observes.

While the same analytics are used in biosimilar development that are used for general protein-based new-product development, it is even more important to link structure to function, Darling remarks. “It is unlikely that a biosimilar production process will yield the same variants in the same percentages as the process developed for the innovator drug, and it is therefore necessary to be able to demonstrate that the differences in variants and variant percentages don’t impact the function of the molecule,” she explains.

Analytics, adds Infante, are the foundation of biosimilar development. “Analytical testing occurs during initial development to characterize the structure and function because analytical data [are] more sensitive than clinical data in detecting differences between a biosimilar and its reference product should they exist,” he says.

Procurement and analysis of multiple batches of the reference product help to establish a baseline that informs subsequent structural and functional similarity tests. “To ensure high confidence in structural and functional similarity between a proposed biosimilar product and its reference product, comprehensive analytical comparison covering a broad disciplinary of analytical techniques should be considered,” Yant states. He adds that analytical similarity assessment should be performed using scientifically sound, fit-for-purpose, state-of-the-art techniques that are sensitive and capable of detecting small differences.

Peptide mapping is particularly important for understanding sequence variations and differences in post-translational modifications, but standard techniques such as capillary electrophoresis, mass spectrometry, liquid chromatography, and binding assays are all crucial, Darling observes.

All of the analytics used to characterize the innovator drug also guide process development both upstream and downstream, according to Stawicki. “There are multiple steps in upstream process development and even more in downstream development, and every single one requires multiple types of analyses. The better the analytical capability—the more sensitive and more informative—the better the process, and optimum processes are needed for every step that can have an impact on quality, efficacy, and yield. It is not possible to design and execute such complicated biosimilar processes without fully characterizing every step,” he insists.

Yant adds that new analytical technologies may help address uncertainties about biosimilarity between the proposed biosimilar and the originator product, but any potential limitations also must be understood.

Advances in analytical technologies can actually create some challenges. Older biologics that have been on the market for some time may have been developed using technologies that are no longer accepted by the regulatory authorities. One example highlighted by Darling is sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS-PAGE). State-of-the-art techniques must be used today to meet regulatory expectations, which requires the development and validation of new methods. Newer modalities such as bispecifics and fusion proteins can also present challenges to biosimilar development with respect to analytical method development.

“The difficulties associated with biosimilar analysis really are dependent on the molecule that is involved. Ion exchange chromatography might work for a monoclonal antibody but not for a bispecific. It isn’t so much that the molecule being developed is a biosimilar, but more that each specific type of molecule requires the right specialized hands-on expertise,” Darling comments.

Established platform technologies invaluable

In most cases, biosimilar developers seek to use standard methods that can be identified using information found in publicly available documents filed on the reference compound or in the general literature. “Although much of the process knowledge about reference compounds is kept proprietary, information about analytical methods is often available, and wherever possible biosimilar developers prefer to leverage the same methods used for the innovator molecule because getting the same results with these methods speaks strongly to regulators,” Darling observes. “If different methods are used, then they must be justified and more work is needed to provide assurance of similarity,” she adds. Ideally, those standard methods are based on platform technologies and standard workflows.

The use of statistical methods to aid in assessment of analytical similarity results has been a topic of debate among regulatory agencies and continues to be discussed by FDA and the European Medicines Agency (EMA). The lack of final regulatory guidance has not, however, prevented successful approval and marketing of biosimilar products in both the US and EU, according to Yant. “Finding analysis methodologies that can be broadly accepted by regulatory agencies for comparative assessment of analytical similarity will streamline biosimilar regulatory submissions and approval processes globally,” he contends.

Evolving design strategies to inhibit biosimilar development

Even with more specific regulatory guidance, the development of biosimilars may get more difficult going forward. “When new biologic drugs are developed today, innovators are thinking from the outset about reducing the ability of competitors to develop biosimilars. Innovator molecules are designed with very tightly defined characterization and structural features—for instance very specific glycans—that make it difficult for anyone to exactly reproduce them,” Stawicki explains. “The strategy today,” he adds, “is to design innovator molecules that have a smooth continuation from innovator molecule to very-difficult-to-copy biosimilar so the original developer can maintain a strong market position throughout the life of the drug.”

Regardless of the design strategy and the complexity of biosimilars, however, a focus on quality must be maintained. “Biologics development, whether for innovator or biosimilar products, is a complex process that requires a quality-based systematic approach. All variables and parameters critical to product quality are identified and rigorously monitored to ensure safe and effective products for patients,” Infante avers.

To create and preserve physician confidence, patient safety, and the integrity of the healthcare system, biosimilars must meet and maintain robust scientific standards before and after approval, Yant agrees. He notes, though, that there has been an increased debate around biosimilar development, with some stakeholders calling for lower regulatory standards around comparative clinical studies and demonstrating interchangeability during the development process. “Amgen firmly believes that rigorous, scientifically appropriate regulatory standards are necessary for the approval, manufacture, and uninterrupted availability of safe and effective biological products, including biosimilars,” he says.

“Analytical data alone,” Yant stresses, “are insufficient to determine biosimilarity. There will always be subtle structural and functional differences between a proposed biosimilar and an originator product. Analytical methodologies alone cannot definitively evaluate the potential impact of such differences on clinical outcomes, including pharmacokinetics, efficacy, and immunogenicity.”

Yant concludes that as biosimilar development continues to evolve, all biological products, including biosimilars, must continue to be held to the same manufacturing quality standards—following the same strict standards of quality, safety, and efficacy—expected for reference products.

FDA, Guidance for Industry. Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product 

Cynthia A. Challener, PhD, is contributing editor for 

Biosimilar data analysis must demonstrate a correlation between structure and function.

Developing Methods for Analyzing Biosimilars

Potential elemental impurities in drug products have been analyzed for many years, with various methods presented in pharmacopeias across the globe. As the world has become more connected, safety and quality compliance within the pharmaceutical

industry has begun to harmonize. For elemental impurities testing, this harmonized work is apparent in the International Council for Harmonisation’s (ICH’s) Q3D guidance documents (1,2).

To learn more about elemental impurities analysis, including the importance of this analytical process, the techniques that are commonly employed, limitations of current techniques, and potential next steps, 

 spoke with Alan Cross, technical specialist at RSSL.

 Why is the analysis of elemental impurities so important in bio/pharma?

 Any analytical testing performed on pharmaceutical and biopharmaceutical materials is primarily to ensure that patient safety is maintained. This is performed either by confirmation that the correct dose of the correct drug substance is being administered or that the dose has no physical or chemical contaminants that may cause harm, or if there are contaminants, that they are below a defined acceptable exposure level. Elemental impurities are no different from any other contaminant, but until recently, the control of these potentially harmful species has been somewhat lacking.

The current elemental testing requirements came into force in 2018 in both the European and United States pharmacopeias following the ICH Q3D document on elemental impurities. This document defined permissible daily exposure (PDE) limits for 24 elements based on robust medical data, which considered the toxicity of the elements and route of administration, and it is written as such to allow for consistent evolution of potential elemental impurity contamination across all pharmaceutical and biopharmaceutical products. This approach has greatly improved patient safety, as it allows for a common approach to controlling elemental impurities based on health risks. Prior to this, elemental testing and limits were often based on the analytical capabilities of the instrumentation or reliance on a colorimetric ‘Heavy Metals’ test, which was insensitive, unspecific, and prone to poor recoveries (500 parts per million [ppm] of mercury in a sample could still give a passing result).

 What analytical techniques are commonly employed to measure elemental impurities in bio/pharmaceutical products?

 Although ICH guidelines do not include any specific recommendations on instrumental methods, the following analytical procedures are suggested in United States Pharmacopeia (USP) <233> dependent on the expected concentration of the elemental impurity in the product or component: inductively coupled plasma–mass spectroscopy (ICP–MS)—parts-per-billion (ppb) concentrations; and inductively coupled plasma–optical emission spectroscopy (ICP–OES)—ppm concentrations. The chapter also sets out recommended analytic procedures for measuring elemental impurities to these methods.

Both techniques are ideally suited to elemental impurity analysis, as they are able to measure multiple elements simultaneously. Therefore, if a full analysis of the 24 elements is required, these techniques are ideal. Both ICP–MS and ICP–OES also allow for a simple screen to take place whereby samples are analyzed against a simplified calibration. This can be powerful in performing risk assessments on samples, as described in the ICH Q3D guideline in which 30% of PDE can be set on a product. If three lots of in-production or six lots of development product tested by the screening method and are shown to be below this level, then further testing may not be required.

As the regulations insist that methods are validated prior to use, this allows flexibility for alternative methods to be used. These methods may be considered based on existing capability, specific chemistry of samples, or simplification of analysis if only one or two elements require testing. Examples might include, atomic absorption spectroscopy (AAS), typically a flame AAS would struggle to achieve the required levels of detection for elemental impurities control but for some elements other forms of AAS can be used which will provide the required detection limits. Vapor generation AAS is sensitive to ppb levels for elements such as arsenic and mercury, and graphite furnace AAS is easily applied to detect lead and cadmium at low levels.

Other techniques that may be employed might be microwave plasma atomic emission spectroscopy, a relatively new technique to the market which uses nitrogen as a plasma gas so has relatively low running costs, when compared to ICP-OES which uses expensive argon as a plasma gas.

Specific mercury analyzers utilize the volatile nature of mercury to allow untreated whole samples as solids or liquids to be analyzed directly by heating and measuring the mercury gas evolved, this simplifies testing and reduces analysis time and preparation costs.

 Could you share any best practices in terms of analyzing elemental impurities in development?

 Preparation of the samples is as important as the analysis itself. Understanding the behavior of the analytes and the sample matrix will allow for robust methods to be developed.

 Are there any limitations with current analytical techniques for the analysis of elemental impurities?

 Traditionally, the main issue with elemental analysis, particularly in ICP–MS with chemical interferences affecting the accuracy of the results, is that over time many modifications to the basic ICP–MS system have allowed for better resolution—with systems such as collision cells and kinetic energy discrimination to remove interferences from the samples. These methods are now also commonly being combined into triple quadrupole systems, which allow for even greater discrimination and reduction in detection limits.

All analytical techniques, with the exception of graphite furnace AAS, use solution volumes in excess of 1 mL for analysis. This is not problematic if there is a large amount of sample, but it can cause issues when the amount of drug product or substance produced is very small, which is becoming more typical in the bourgeoning biologics and biosimilars field. This means that novel preparation techniques need to be employed that can work with small sample amounts and final volumes to maintain the required detection limits, as well as further use of sample introduction systems that can work with small volumes, which are currently employed in some instrumental set‑ups.

 How about the advantages of the current techniques? Could you run through some of those?

 The advantage of the key analytical techniques, such as ICP–MS, ICP–OES, and AAS, is that they are truly multi-elemental techniques. These systems can analyze, either simultaneously or sequentially, the majority of the periodic table. The instrumentation manufacturers are constantly working towards lower detection limits and better resolution, as well as interference control.

 What trends do you foresee impacting elemental impurity analysis in the future?

 The food industry has had a particular interest in the speciation of certain elements, such as arsenic and mercury, where the form (organic or inorganic) has a big impact on the toxicity, and this consideration is also included in the USP/EP/ICH guidance. If a drug product is found to have levels of arsenic or mercury exceeding the PDE levels, speciation could be used to discriminate between toxic and less toxic forms to demonstrate compliance with the regulations.

Felicity Thomas is the European editor for Pharmaceutical Technology Group.

To ensure patient safety, drug products must be tested for elemental impurities that pose risk.

Elemental Impurity Analysis Crucial to Patient Safety

Avid Bioservices, a biologics-focused contract development and manufacturing organization, announced the opening of new analytical and process development (AD/PD) suites within their recently built 53,000-ft2 viral vector development and manufacturing facility. Build-out of the suites is currently ongoing and expected to be completed by mid-2023.

According to a June 14, 2022 press release, the new suites will be equipped with complete upstream, downstream, and analytical development capabilities. The suites will be able to support up to 500-L suspension culture in single-use bioreactors and various adherent cell modes. The company's viral vector AD/PD team has worked on technologies for viral vector production and purification processes focused on adeno-associated viruses (AAVs), lentiviruses, oncolytic viruses, and other viruses for gene therapy and vaccine applications.

“We believe that we are uniquely positioned to leverage our deep expertise in the manufacturing of traditional biologics to address the growing demand for high quality manufacturing of cell and gene therapies,” said Nick Green, president and CEO, Avid Bioservices, in the press release. “Today’s launch of our AD/PD labs is a crucial first step in our expansion into the viral vector space as we remain laser focused on smart and sustainable revenue growth for our business.”

News

Avid Bioservices has expanded its viral vector development and manufacturing facility with the addition of analytical and process development suites.

Avid Bioservices Launches New Analytical and Process Development Suites at Viral Vector Facility

According to a June 15, 2022 press release, a new polymer surface material has been invented by researchers at Chalmers University of Technology (Gothenburg, Sweden) that uses electrical signals to both capture and release biomolecules.

The new material may have an impact in the way that biomedicines are developed and could provide opportunities in the development of remote-controlled medication and electronic pills. The results of the research were published in a scientific journal, 

“Our polymer surfaces offer a new way of separating proteins by using electrical signals to control how they are bound to and released from a surface, while not affecting the structure of the protein,” said Gustav Ferrand-Drake del Castillo, doctor in Chemistry, Chalmers, CEO of Nyctea Technologies, and lead author of the study, in the press release.

The initial research behind the material was performed by Ferrand-Drake del Castillo while studying under the stewardship of Chalmers professor Andreas Dahlin within the university’s Division of Applied Surface Chemistry. The research project involved polymer surfaces that can change their state when the pH of the surrounding solution is adjusted—so, changing between neutral and charged.

“Shortly afterwards we discovered that we could use the electrical signals to control the binding and release of proteins and biomolecules, and that the electrode material works in biological solutions such as serum and centrifuged blood. We believe and hope that our discoveries may be of great benefit in the development of new medicines,” explained Dahlin, in the press release.

Additionally, the material was found to also work within biological fluids with the ability to counteract changes in pH values. Through this specific property of the polymer surface material, it may be possible for the researchers to create a new technique for implants and electronic pills, whereby the medicine is released within the body through electronic activation.

“You can imagine a doctor, or a computer program, measuring the need for a new dose of medicine in a patient, and a remote-controlled signal activating the release of the drug from the implant located in the very tissue or organ where it’s needed,” added Ferrand-Drake del Castillo. “Being able to control the release and uptake of proteins in the body with minimal surgical interventions and without needle injections is, we believe, a unique and useful property. The development of electronic implants is only one of several conceivable applications that are many years into the future. Research that helps us to link electronics with biology at a molecular level is an important piece of the puzzle in such a direction.”

New Technology

A new polymer surface material has been invented by researchers in Sweden that uses electrical signals to both capture and release biomolecules.

Researchers Invent New Material that Can Capture and Release Biomolecules

Bio-Rad announced the launch of the SEQuoia Express Stranded RNA Library Prep Kit on June 6, 2022. The kit is designed to construct robust libraries for efficient RNA sequencing (RNA-Seq) workflows in comprehensive transcriptome profiling.

According to a company press release, the SEQuoia is a three-tube kit that uses a novel reverse transcriptase and a ligation-free adaptor addition chemistry to produce a reproducible, quantitative RNA-Seq library in three hours. The kit allows researchers to construct robust libraries that capture messenger RNA and long noncoding RNA (> 200 binding proteins) transcripts for differential gene expression analysis and novel transcript delivery.

“Current RNA library preparation approaches are time-consuming, complex, and potentially error-prone, with sample loss observed at each stage in processes with multiple steps,” said Simon May, executive vice-president and president, Life Science Group, Bio-Rad, in the press release. “Bio-Rad offers scientists an enhanced solution, combining its rapid NGS [next generation sequencing] library preparation with integrated data analysis to overcome these difficulties and enable the widespread adoption of RNA-based sequencing."

Bio-Rad’s SEQuoia Express Stranded RNA Library Prep Kit is designed to construct efficient RNA sequencing workflows.

Bio-Rad Launches SEQuoia Express Stranded RNA Library Prep Kit

Axol Bioscience, a provider of induced pluripotent stem cell (ISPC)-derived cells, media, and characterization services for life science discovery, announced that its IPSC-derived ventricular cardiomyocytes have undergone comprehensive 

 pro-arrhythmia assay (CiPA) validation on June 7, 2022. This assay showed that the cells were suitable for measuring cardiotoxicity, which offers scientists a robust cardiac model for drug discovery and screening.

CiPa is a working group developed by FDA to assess the utility of human iPSC-derived ventricular cardiomyocytes by reproducing cardiotoxicity in a dish. The assay tests cells with 28 compounds that are known to be cardiotoxic and induce the fatal arrhythmia “Torsades de Pointes”. According to an Axol press release, Clyde BioSciences, a contract research organization that specializes in cardiotoxicity assays, used this assay to validate Axol’s cardiomyocytes for cardiac safety testing.

“As a core member of the CiPA initiative, we’re pleased to have supported Axol’s cell development and helped the team assess the performance of its cardiomyocytes,” said Godfrey Smith, chief scientific officer, Clyde Biosciences, in the press release. “Having run the CiPA protocol on Clyde’s proprietary CellOPTIQ platform, and provided analysis and interpretation of the data, we confirm our data indicate that Axol’s cardiomyocytes meet the requirements for predictive 

Axol’s human iPSC-derived ventricular cardiomyocytes provide a continuous source of cells from the same genetic background for use in multiple experiments and a physiologically relevant 

 research model of human heart cells. This allows for reliable, repeatable cardiotoxicity testing for drug candidates at scale.

“Scientists need cells and reagents they can rely on to make meaningful assessments of drug candidate toxicity, before progressing candidates to the clinic,” said Liam Taylor, CEO, Axol Bioscience, in the press release. “We’re both excited and proud to demonstrate the suitability of our human iPSC-derived ventricular cardiomyocytes for toxicity testing. Axol’s stringent quality control standards mean we have the capability to produce reliable, validated cells that scientists can use to assess a compound’s cardiac liability and, ultimately, help to improve the drug discovery process.”

Axol Bioscience’s CiPA-validated ventricular cardiomyocytes can be used as a robust cardiotoxicity measurement tool.

Axol Bioscience Announces CiPA-Validated Human Stem Cell-Derived Ventricular Cardiomyocytes

Bio-Rad Laboratories announced the launch of the CFX Duet Real-Time PCR System on May 26, 2022. The CFX Duet is designed to help researchers develop singleplex and duplex quantitative polymerase chain reaction (qPCR) assays.

According to a company press release, the CFX Duet is a two-color system that is factory calibrated for common dyes, allowing for the precise quantification of up to two targets in genotyping and multiple gene expression analysis without the need for passive reference dies. The device features thermal gradient functionality to enable optimization in fewer runs.

An additional fluorescence resonance energy transfer (FRET) mode supports protein melt analysis for basic protein characterization. The device uses CFX Maestro Software for easy experimental setup and analysis, allowing it to deliver customized reports without exporting data to other programs.

“We are pleased to expand our portfolio of qPCR instruments with the CFX Duet System to help customers run singleplex and duplex assays with a software that matches the robust thermal capabilities of our premium CFX Opus formats.” said Steven Blakely, director for gene expression and software technology, Bio-Rad, in the press release. “The versatile CFX Duet System allows users to quickly get started with gene expression, genotyping, quantification and thermal gradient optimization, as well as protein characterization using FRET.”

BioRad Laboratories CFX Duet System is designed to help researchers develop singleplex and duplex quantitative polymerase chain reaction assays.

Pharmaceutical Technology's In the Lab eNewsletter, July 2022