Mass spectrometry (MS) is a key analytical technique of the biopharmaceutical industry, with applications from early development to quality control (QC). Disjointed software practices, however, are a major impediment for researchers. Integrating advanced software packages can streamline the process of data acquisition and analysis for MS, facilitating collaboration and accelerating the pace of innovation.

Thanks to advances in automation, sensitivity, and speed, MS has become an indispensable element of the drug development process. Applications are wide-ranging and include the identification of proteins in complex biological matrices, high-throughput analysis of recombinant proteins, optimization of bioprocesses, protein characterization, rapid screening of drug-target binding, and QC (1).

In each of these cases, the accurate and efficient collection of data is paramount. However, achieving this can be a challenge, as studies often involve collecting and processing data from a wealth of different instruments. A lack of connectivity between instruments makes the process time consuming and prone to error, as data can be lost along the way.

Part of the problem is the number of different software packages used for data acquisition and analysis. This can lead to so-called “disjointed data” where results are stored in siloes and are often not centrally accessible, preventing easy access and requiring data transfer, which can lead to the loss or corruption of data.

In this article, the authors explain how integrating modern software tools can make the acquisition and analysis of MS data more efficient, accurate, and compliant. These software tools offer integrated and connected solutions, so that large amounts of data can be efficiently stored, analyzed, and accessed globally.

Practices for acquiring, organizing, and analyzing MS data are disconnected

MS is typically hyphenated to a separation technique to achieve separation of components and to reduce matrix effects and increase sensitivity. A range of chromatography–MS–based workflows, such as liquid chromatography (LC)–MS and imaged capillary isoelectric focusing (iCIEF)–MS, are used in the biopharmaceutical industry for a variety of purposes (2).

Whatever the particular workflow, data acquisition and management is typically performed using a chromatography data system (CDS), a software package or set of software packages that connects directly with, and acquires data from, the chromatography equipment. Simple processing, such as integration of peaks, may also be performed using the CDS. More complex analysis, such as protein characterization, usually requires additional and more specialized software tools.

This means researchers often use multiple, disconnected software platforms to acquire and analyze the data from their MS experiments. Previously, software was used as a standalone, meaning data was stored locally and could not be accessed remotely or by multiple people simultaneously. It also meant that users had to manually transfer data between instruments and computers with the different software packages. As MS technology and use cases advance, this approach is no longer sustainable, especially for the analysis of large datasets.

Increasingly large and complex datasets present new challenges

The number of MS users, workflows, and opportunities to connect to alternative separation and detection methods are continuing to increase. Advancing technology also means modern instruments are faster and increasingly automated, which accommodates higher throughput and allows for the generation of larger and more complex datasets from MS experiments. Gigabytes of data can be generated from a single instrument in a month; across a whole lab, which could amount to terabytes of data each month.

This deluge of data is driving new scientific insights but also presents challenges for the conventional processes of acquiring and managing data. The first of these challenges is storage, as such large amounts of data cannot be stored locally without risking data loss. Local storage also creates challenges for access, making it difficult to share results between scientists and across sites.

What’s more, when results from different experiments are stored separately, they must be transferred between instruments and software platforms. This is inefficient, time-consuming, and introduces the risk of information being lost or corrupted along the way.

Data generated and stored using traditional, separated software platforms can also be difficult to search and retrieve. The ability to quickly find relevant results becomes increasingly important as the volume of data increases, but this is challenging without robust organizational structures and comprehensive metadata.

Metadata can be thought of as the “data that describes other data” and might include the time/date an experiment was performed, the person who performed the experiment, the instrument used, and the processing parameters (3). As well as assisting in data retrieval, metadata can be useful during analysis, for project progression and review, and to maintain regulatory compliance.

Modern software solutions streamline data acquisition and analysis

As MS becomes increasingly routine during the drug development pipeline, it is important to have the right software to support this.

Progressive CDS can manage data from multiple instruments, streamlining chromatography and MS analysis into a single software platform. Meanwhile, a cutting-edge protein characterization software can monitor post-translational modifications and other critical quality attributes quickly and efficiently. Modern software solutions are being designed to integrate with one another to enhance data management and analytical workflows.

Utilizing these tools as an integrated software platform has a number of advantages for users. For example, automated and streamlined data acquisition and processing saves time. One central CDS can acquire and analyze data from both chromatography and MS instruments, and provide data for downstream analysis. In addition, advanced integrative software is generally more intuitive and easier-to-use. Multiple instruments are supported on one platform, providing the same user interface and results in the same format. Templates are also available for different workflows including pre-defined parameters for different separation techniques, which increases ease-of-use, reduces the likelihood of errors in the analysis process, and ensures results are comparable. What’s more, integrating software solutions eliminates the need to frequently transfer data between different software platforms, which mitigates the risk of data being lost or corrupted.

The latest software tools also offer specific capabilities for work on complex biotherapeutics, including identification of proteins and monitoring of post-translational modifications, while data storage and security are improved. With data stored on a secure server, the limits of local storage capacity are removed. Secure storage is also a key component of data integrity, which is important for maintaining regulatory compliance. Data security has become even more important during the COVID-19 pandemic, with an increasing number of scientists working (and accessing data) from home.

Furthermore, centralized data helps to ensure remote access, allowing users to retrieve results in the lab, in the office, or from home, with the same performance as a local operation. Another advantage is that metadata is generated automatically and simplifies the process of organizing and searching data. This includes the creation of audit trails, which maintain a historical record of system, instrument, and user events. This provides traceability and preserves data integrity, which are needed to meet good practice (GxP) regulatory requirements. Combined, these benefits mean scientists can spend more time on research and analysis, driving innovation and discovery.

Integrated software supports innovation in the biopharmaceutical industry

Combining an innovative CDS with modern protein characterization software also generates significant benefits for the biopharmaceutical industry. MS is routinely used across the drug development pipeline for characterization, formulation development, process characterization, stability studies, and QC. Advanced software tools can benefit each of these stages.

Optimized data collection and streamlined analytical workflows increase efficiency and confidence in output, with benefits for individual organizations and the biopharmaceutical industry as a whole. These benefits include reduced training requirements for staff, where more intuitive and consistent software with greater automation reduces the need for specialist training. Such software also reduces the impact of staff absence, as the software for multiple instruments can be used by any analyst and data can be easily searched and retrieved, regardless of who generated it.

Another benefit is cost savings, which is achieved because the overall pipeline is made more efficient by innovative software tools that reduce the need for manual processing and data transfer. Modern software tools can also automate or partially automate many aspects of the workflow, such as sequence creation, error handling, chromatogram processing (including peak detection and integration), and graph and report creation. What’s more, CDS provide a comprehensive set of compliance tools to make it easier to meet regulatory requirements such as GxP guidelines. These tools include accurate metadata and audit trails, laboratory monitoring (including the ability to search and filter for high-risk events), streamlined report generation, and data review processes.

Collaboration, which is a major driver of innovation in the biopharmaceutical industry (4), is also supported as partners at different sites can easily access and share data.

Ultimately, the efficiency gains made by streamlined analytical workflows result in an accelerated innovation process, a faster time to market for new biopharmaceuticals, and a quicker return-on-investment.

Modern, connected software tools can also increase confidence in the quality of the final product thanks to rich and accurate data and built-in compliance and data integrity tools, including audit trails, which can be used to detect data integrity issues and provide the history behind an action.

As well as traceability, modern software tools also provide enhanced data security, including privileged access systems. Together, these tools can help organizations to meet the requirements set by major regulatory bodies such as FDA, the UK Medicines and Healthcare products Regulatory Agency, and the European Medicines Agency.

The scale of data being generated by increasingly sophisticated MS techniques is both empowering the biopharmaceutical industry and revealing bottlenecks in the industry’s data processing and analysis pipelines. Previous MS workflows with manual data processing, single-user limitations, local storage, and missing metadata are no longer practical.

Innovative CDS and protein characterization software overcome these limitations, and their integration is an act of future proofing for the biopharmaceutical industry. They offer a single software platform with seamless connectivity for the generation, storage, and analysis of data and a centralized server-based system that ensures information is accessible to everybody. This also generates productivity gains thanks to streamlined and automated workflows, freeing up scientists to invest more time in their research projects.

Regulatory compliance is a priority for the industry and is supported by modern software solutions. These software solutions can increase industry confidence in meeting GxP guidelines by providing tools for robust documentation, security, and traceability.

Integrated, automated, and cloud-based data management systems can help the biopharmaceutical industry to make the most of the escalating volume and complexity of analytical data. MS is now an integral part of the drug development pipeline and streamlining its role in this process, from discovery to QC, ultimately means a quicker time to market. Biopharmaceutical production needs GxP just as traditional pharma needs it, and being able to implement GxP guidelines seamlessly helps contribute to product quality.

 2, 140–150 (2003).
2. G. Loos, A. Van Schepdael, and D. Cabooter, 

Series A, Mathematical, Physical, And Engineering Sciences

 374 (2016).
3. WHO, “Good Chromatography Practices (Draft for Comments),” 

 33 (2) (July 2019).
4. N. Lesser and M. Hefner, 

Partnering for Progress: How Collaborations are Fueling Biomedical Advances

Peter Zipfell is product marketing manager, CDS Software, at Thermo Fisher Scientific, and Michelle English is Data Science product manager at Protein Metrics.

Articles

Features

The acquisition and analysis of MS data can be made more efficient with the integration of modern software tools.

Streamlining Biopharma MS Workflows Using Connected Software Solutions

Advancements in analytics have significantly increased the amount of data that is generated throughout the biologic drug lifecycle. This increased data flow presents challenges to managing the information. Managing the increased output is best achieved with the help of automated analytical workflows, which can organize data collection and streamline analyses.

Incorporating automation into the workflow

The biopharma industry has seen a significant increase over the past few years in the complexity and variety of biomolecular therapies. Manufacturers have found themselves often facing situations in which existing platforms and prior knowledge no longer apply to newer molecular formats, says Xiao Dong, marketing manager, Biopharmaceutical Business, Waters Corporation. As a result, larger-scale analytical testing is needed, especially during earlier-stage development, to minimize the risks associated with manufacturability and quality, Dong states.

“Automated analytical workflows allow manufacturers to address the gap between existing analytical capability and increased testing needs by reducing resource costs and improving turnaround time. In addition, automation improves data quality and reduces FTE [full-time employee] resource needs, leading to cost benefits as well as reduced compliance risks,” says Dong.

The drug discovery and development process involves a series of complex stages that take 12–15 years to commercialize and cost between $0.9 billion and $2 billion, with a low success rate, says Anis H. Khimani, PhD, senior strategy leader, Pharma Development, Life Science, PerkinElmer. “Workflows within every stage contribute to large volumes of data that require management and interpretation, for both small- and large-molecule drug development,” Khimani says.

Over the past two decades, the discovery and development of large-molecule therapeutics has seen significant progress in the areas of target characterization, screening, process optimization, automation, and analytics, Khimani explains. Implementation of automation and analytics across biologics workflows has played a key role in this success; they have enhanced productivity and are overcoming big data management challenges.

“Automation and data management deliver accuracy and reproducibility as well as enhance data quality and biological relevance. Furthermore, more recent advancements in artificial intelligence (AI) and machine learning have enabled predictability and process design,” Khimani points out.

In the drug target identification (ID) and drug discovery space, next-generation sequencing (NGS) has revolutionized target discovery across the genome, exome, and transcriptome paradigm, while bioinformatics capabilities have enabled panel design for specific disease areas and the screening of disorders at the population genomics level, Khimani emphasizes.

Moreover, automation solutions in liquid handling and nucleic acid sample preparation continue to empower scientists in achieving higher throughput, accuracy, and reproducibility along the target ID workflows, Khimani adds.

“Drug discovery involving large-molecule screening has benefited significantly from automation and leveraging analytics. Integrating a workflow through interface and protocol configurations enables each step involving related instrument(s), software, and consumables to offer a seamless process, data generation, data interpretation, and biological evaluation,” he states.

Regarding protein characterization, the implementation of automation workflows and AI tools has accelerated protein characterization and process development by enabling critical quality attributes (CQAs) and streamlining integration. According to Khimani, capillary electrophoresis (CE) platforms with higher throughput, for example, have enabled lower sample requirement, superior resolution of isolated/separated proteins, and reliable characterization.

For process development and scale up, it is important to remember that CQAs for biologics involve cell culture and production process parameters as well as storage conditions to ensure stability along the workflow. “In this context, an important data analytic to monitor is long-term stability on three production batches. Temperature

mapping services (e.g., OneSource, PerkinElmer), can help biopharma operators monitor variations and maintain consistency supporting good laboratory practice (GLP)/good manufacturing practice (GMP) compliance,” according to Khimani.

Meanwhile, fully automated reports and advanced techniques, such as wireless temperature probes, reduce human error, while software solutions support data visualization of stability studies. Other quality control measures, such as impurities testing, can be achieved using analytical tools such as chromatography and atomic and molecular spectroscopy, Khimani says.

Automation technologies are also key in helping to collect and organize increased data output, which facilitates data analyses. The integration and automation of workflows results in enhanced data output at every step, from configuration of integration through metadata management and eventually data analysis, visualization, and interpretation, Khimani points out. Over the past decade, the adoption of electronic lab notebooks (ELN) have facilitated the migration of data-related content from paper notebooks to electronic formats. These electronic formats manage unstructured and structured data and provide for subsequent analysis and visualization.

“The clustering and visualization of vast volumes of data enable scientists to gain biological insights into target characterization and validation. There has been increasing awareness that identifying and validating the right target upstream is critical to the screening and development of drug candidates downstream to further enhance the success rate of therapeutic molecules,” Khimani explains.

Advanced analytics technologies (e.g., TIBCO Spotfire, PerkinElmer) offer data analysis and visualization capabilities for this workflow; these capabilities play a critical role in decision-making. Additionally, ELN technologies (e.g., Signals Notebook, part of the new PerkinElmer Signals Research Suite) can enable audit trail and security features to support 21 

) Part 11 (1) compliance within the biologics GMP environment. “Huge volumes of data either require database capabilities or a cloud environment that can be maintained on site or outsourced via third-party informatics solutions. Implementation of Biopharma 4.0 is being adopted and driven by the principles of Industry 4.0 to improve efficiency, facilitate real-time monitoring, reduce cost, enhance predictability, and allow for better decision-making within bioprocess workflows,” emphasizes Khimani.

Some of these advanced automated technologies are leveraged both upstream in drug discovery and development as well as downstream in bioprocess development and manufacturing; however, the requirements differ, Khimani points out. He explains that discovery workflows upstream seek flexibility and an open format to organize and develop protocols followed by management of structured data. “Research scientists may need to vary experimental conditions to optimize protocols into SOPs [standard operating procedures] as well as analyze a wide array of data for biological relevance,” he says.

An ELN notebook (e.g., Signals Notebook, PerkinElmer), for instance, provides the latitude to manage metadata and analyze various groups of experimental data into visualization formats to enable decision-making. Biopharma research groups leverage the capabilities of ELN to optimize workflows to enable discovery and validation of disease-specific targets as well as the development of large-molecule therapeutics.

Meanwhile, further downstream in drug development, these advanced technologies also facilitate validation and security requirements within the GLP and GMP environments. ELN notebooks (e.g., Signals Notebook, PerkinElmer) can offer security-driven administration and audit capabilities. In the manufacturing environment, scale up for higher production volumes and GMP compliance are key. “Therefore, downstream it is important for analytics technologies to support automation, as well as provide electronic compliance supporting capabilities for biopharma to be able to meet regulatory requirements. Bioprocess workflows have continued to migrate from a batch process to continuous manufacturing; hence, there is a constant demand in this space for technologies to offer real-time monitoring and accuracy to maintain production that is devoid of errors and meets scale, sterility, and safety requirements,” Khimani says.

Gunnar Schaefer, co-founder and chief technology officer of Flywheel, a research data management platform, notes the importance of having end-to-end solutions to streamline data ingested from multiple sources and curate it to common standards. Focusing on the facilitation of large-scale organization, processing, and analyses of complex data, such as annotated biomedical images frequently collected as part of clinical trials, can enable real-world data collaboration, machine learning, and AI development, all of which can accelerate drug discovery, Schaefer says.

Historically, for instance, most data assets collected in clinical trials were archived and largely forgotten, often stored with partners offsite, Schaefer observes. “With the broad adoption of machine learning, these data assets have gained a second life. However, many data archives are offline or otherwise inaccessible, poorly organized, and seldom quality-controlled,” Schaefer states.

Addressing those problems head on, starting with flexible and scalable data ingestion and establishing a de-identification framework as well as having a customizable and multi-modal data processing automation and structured annotation options, goes a long way towards optimizing analytical workflows. “In concert, these capabilities accelerate [the] path to meaningful data at scale,” Schaefer explains.

Khimani adds that bottlenecks in data collection and processing exist at every step of the workflow, with greater challenges arising when higher volumes of data are generated from automation and real-time monitoring of the process. He points out that multiple factors contribute to data overload in the process development and scale-up environment, such as the evaluation of process parameters, raw material requirements, and monitoring along the workflow, including product stability, media components, and microbial presence. Additionally, data across the workflow is obtained and sorted manually using accessory tools or devices.

“Further contributing to bottlenecks is the use of complex spreadsheets. [In addition,] locally developed or third-party software may be utilized to collect and process data. These programs can be labor- and time-intensive and may result in errors,” Khimani says.

“Automation across workflows with centralization of informatics tools to manage data can alleviate these bottlenecks,” Khimani continues. “Subsequently, data can be structured, tracked, and processed for visualization, as well as archived for future reference.” Furthermore, adoption of the holistic automation tenets of Industry 4.0 with enhanced process technologies, as well as advanced digital solutions, can alleviate numerous bottlenecks. Having an automation roadmap such as this aims to deliver enhanced robustness and reproducibility of quality metrics and can significantly reduce cost, provide flexibility, and enhance productivity, Khimani concludes.

Automating the entire analytical workflow often requires a manufacturer to integrate solutions from different vendors. This often requires steep learning curves, cautions Dong. Thus, working closely with different vendors while having a cross-functional team that can work on data and system integration are essential requirements.

“Automated platforms need to be flexible, because the number of samples can vary. The platforms themselves should not be complex or hard to operate as many of these scientists are not automation engineers,” explains Dong. “Easy-to-use platforms with simple, user-friendly informatic interfaces will be critical to successful implementation. Additionally, it is often a good practice to start implementing automation in non-GMP development settings before GMP manufacturing, which has higher compliance needs.”

Furthermore, automated analytical workflows require access to large-scale, standardized, quality-controlled, and expert-labeled datasets, adds Schaefer. At the same time, data privacy and security requirements are becoming ever stricter. A comprehensive data management and sharing framework would allow researchers to focus on new discoveries, rather than solving information technology problems, Schaefer notes.

Although the level of automation and data management across analytical workflows differs between a laboratory setting and a bioprocess environment in terms of the scale and compliance requirements, there are important common themes, says Khimani. These common themes include streamlined workflows, standardization of protocols, and reproducibility.

The main components required to allow the implementation of fully automated analytical workflows, either in the laboratory setting or in a commercial biomanufacturing setting, include workflow integration, informatics capabilities, standardization, quality control programs, and digitization, Khimani states.

Workflow integration includes a customized configuration using informatics capabilities, which translate protocols interfacing from one step—or from an analytical instrument of the workflow—to the next. This configuration is designed to enable walk-away automation with the least manual intervention, according to Khimani.

Khimani also explains that, at an enterprise level, an organization requires informatics solutions that are either cloud-based, local databases, or laboratory-level laboratory information management systems (LIMS) platforms for the management of various instrumentation and data communication. Standard software tools to enable data analysis and visualization are useful at the end-user level, Khimani points out. A laboratory informatics footprint allows security-based central monitoring of analytical workflows, data management and archiving, root cause analysis (RCA), and enhanced productivity and cost-savings.

Having reference standards programs across hardware calibration, reagents, and consumables can establish uniformity across workflows. Most importantly, such standards enable reproducibility, reliability, and monitoring of results for errors and deviation. Timely qualification and calibration of instruments and tools is critical to maintaining reliability. The use of appropriate reference standards or controls for assay and diagnostic reagents establishes quality control for the consumables and the entire assay, says Khimani.

Ensuring monitoring as well as identification and control of any deviations for quality control requires a disciplined and systems approach that proactively establishes workflow and process design requirements (e.g., quality by design established within drug manufacturing) across laboratories and scale-up environments. Any further deviations can also be managed via RCA. Moreover, in biomanufacturing, RCA, can point to whether critical process parameters (CPPs) and CQAs are being met.

In addition to informatics capabilities, empowering the laboratory—and the bioprocess ecosystem in particular—with digitization and AI capabilities enables continuous manufacturing, real-time monitoring, process predictability, and superior control of the workflows, emphasizes Khimani. He explains that data captured at every step from this streamlined digitization can be analyzed to develop both real-time and predictable models to ensure CPPs and delivery of CQAs.

 Title 21, 11 (Government Printing Office, Washington, DC).

Feliza Mirasol is the science editor for 

The automation of analytical workflows generates higher volumes of data that also require advanced technologies to manage.

A Look at Managing Increased Data Output Through Automation

Revolutionary therapies and innovative drugs can largely be attributed to the research, development, and manufacturing work conducted by the bio/pharm industry. Contributing to that success, however, are the contributions of laboratory technology manufacturers.

As much as new therapeutics are continually discovered, researched, and developed, innovative laboratory equipment is continually being developed, improved upon, and intro- duced to the market. A primary goal of these lab equipment innovations is to improve the efficiency of the drug develop- ment cycle or unlock as yet unknown benefits for researchers. A summary of some of the most recent product innovations to hit the laboratory scene are highlighted below.

Announced in January 2022, Refeyn’s SamuxMP mass photometer is designed to be used with only basic train- ing. Intended for use in adeno-associated virus (AAV) analytics, it has a mass range tailored for AAV analy- sis and provides accurate results in less than five min- utes from sample loading to final result. Combined with low-operational costs and a small footprint, the SamuxMP enables routine quantification of empty/full AAV capsid ratios, even in smaller labs, to set a new stan- dard in AAV characterization.

The SamuxMP is designed to overcome the drawbacks of the current analytical methods by enabling users to rapidly and cost-effectively determine empty/full capsid ratios for AAVs of any serotype at the bench using very low sample volumes and concentrations with minimal sample preparation. This is intended to enhance produc- tivity and speed up workflows through more frequent analyses in-house, making R&D and process development of gene therapies and AAV-based therapeutics signifi- cantly more efficient (1).

Bio-Rad's Bio-Plex Pro Human SARS-CoV Variant Neutralizing Antibody Assays

Bio-Rad Laboratories announced in December 2021 that it would be offering new Bio-Plex Pro Human SARS-CoV Variant Neutralizing Antibody Assays for use in measuring neutralizing antibodies. The product con- sists of a ready-to-use 96-well kit containing premixed magnetic capture beads, a detection converting enzyme (ACE)-2 receptor, a standard and positive control, and buffers that measure levels of neutralizing antibodies and percentage inhibition of the ACE-2 receptor binding the viral antigens coupled on the beads.

The assays are being offered in an 11-plex complete all-in-one kit format that consists of wild-type receptor-binding domain and S1 and 9 variant antigens, customizable sin- gleplex assays, and 2-plex Delta variant coupled beads. Additionally, a custom Assay Developer Kit to create assays for any new SARS-CoV-2 variant—such as Omicron—is included. This customizability may prove invaluable as mutant strains of COVID-19 continue to develop (2).

In November 2021, BioChromato released data supporting the notion that its Smart Evaporator C1, designed for preparing microbial degradation culture media for analysis, can utilize a novel bioremediation technique to improve the detoxification process for persistent organic pollutants (POPs) that cannot be decomposed by natural processes in soil.

According to an interview the company had with an anonymous researcher, various advantages were found relative to rotary evaporators:

The Smart Evaporator C1 can evaporate culture medium samples without azeotroping, saving a significant amount of time relative to rotary evaporators.

Rotary evaporators are at risk of water contamination from the steam adsorbed from the water heating bath. The CI instrument avoids this risk because it does not need water.

Researchers no longer have to monitor the process to avoid solvent bumping— because the C1 instrument operates under normal pressure, samples can be left unattended (3).

OpenEye, in a partnership with Specifca, launched the Orion Antibody Discovery Suite, a jointly developed software, in December 2021. Orion is designed to identify diverse antibody sets with better properties for down- stream therapeutics development. The product exclusively features Specifica’s AbXtract software, an antibody discovery module that uses proprietary artificial intelligence methods to analyze large amounts of sequence data.

OpenEye claims that Orion is the only cloud-native fully integrated software-as-a-service molecular modeling platform. Orion uses Amazon Web Services, which provides it with unlimited storage and computational scal- ability in tandem with its data sharing, visualization, and analysis tools (4).

MilliporeSigma's ColorWheel Flow Cytometry Antibodies and Dye

Announced in November 2021, MilliporeSigma’s ColorWheel Flow Cytometry Antibodies and Dyes present the latest advancements in cytometry profile technology. The product allows users to select antibodies and dyes for assembly in any desired combination, resulting in an output of mix-and-match antibodies and dyes analogous to a primary conjugated antibody.

According to MilliporeSigma, multiplexing in flow cytometry can be difficult because researchers must consider instrument configuration, antigen expression and dye brightness balance, and antibody–dye combination avail- ability. In this regard, the ColorWheel is designed to overcome these constraints by making it easier to build a new multiplex assay for samples with varying expression levels of antigen.

Other notable features of the ColorWheel include:

Flexibility to pair any antibody with any dye in a ready-to-use, convenient format

Can be used in five minutes of hands-on time, minimizing necessary time and effort

Preservative-free presentation that promotes sustainability and wider sample type compatibility

Lyophilized product, enhancing stability and allowing for ambient shipping (5).

Satrotius' Sartolab RF|BT 150–1000 Vacuum Filtration Units

Sartorius introduced the new Sartolab RF|BT 150–1000 Vacuum Filtration Units in November 2021. Designed to offer faster and higher capacity filtra- tion, the new filtration units also allow for enhanced physical stability for a wide range of sample types through a newly optimized center of gravity.

The RF|BT 150–1000 has an increased membrane surface area designed to facilitate optimal filtration. Additionally, there is an 0.45- μm polyethersulfone membrane in place of the 0.45-μm cellulose acetate membrane, which increases flow rate while keeping the same low-protein binding properties.

The new units can be directly used on the Sartolab Multistation for par- allel filtration. Additionally, the new vacuum filtration units are available in three different pore sizes to meet the needs of most applications:

: sterile filtration of cell culture media, buffers, and reagents

: clarification of aqueous and viscous solutions (6).

Thermo Fisher Scientific's Orbitrap Exploris MX Mass Detector

Thermo Fisher Scientific unveiled the Orbitrap Exploris MX Mass Detector at the 69th American Society for Mass Spectrometry Conference on Mass Spectrometry and Allied Topics in October 2021. The new mass detector allows biopharmaceutical laboratories to implement multi-attribute method (MAM), an analytical extraction technique that can extract large amounts of different quality parameters of a protein via a single analytical approach.

In addition to MAM, the Orbitrap can perform intact analysis of monoclonal antibodies, conduct oligonucleotide mass determination, and carry out peptide mapping. According to Thermo Fisher, this instrument simplifies the transition of biotherapeutics from development to manufacturing and enables quality control customers to use the same method established earlier in a molecule’s journey to commercialization. This design is intended to accelerate the overall biopharma development pipeline (7).

CuriRx announced the CuriLytics Platform in September 2021. Designed to support the development of complex biotherapeutics, CuriLytics uses high-resolution mass spectrometry and various orthogonal characterization methods to characterize modern bio- pharmaceutical drugs, including:

Ultimately, the platform can iden- tify quality attributes of protein can- didates at the individual residue level, which can be used to provide context to effects brought about by changes to the process or production of the drug (8).

Bürkert Fluid Control Systems new scalable chemical disinfection system features a compressed air-operated dual-substance nozzle that provides homogenous and fine aerosol formation of hydrogen peroxide with minimal chemical and energy input.

The system is designed for applications such as sterilizing packages, cleaning high efficiency particulate air filters, or disinfecting rooms. In operation, hydrogen peroxide is pumped from a stainless-steel container to a liquid flow controller. Atomizing air is metered to the nozzle through a mass- flow controller, producing a fine mist. The measured material flows enable the control of disinfection time.

The modular preparation system can be customized to suit customer needs to include heaters, integrated flushing, safety devices, or control cabinet integration with programmatic logic controllers (9).

The Lasair Pro Airborne Particle Counter from Particle Measuring Systems, announced in July 2021, supports a range of applications, including clean-area monitoring and classification while meeting international cleanroom certification standards.

The instrument is designed to meet increasing data integrity and regulatory requirements, featuring integrated audit trail capabilities. Sampling activities can be programmed and managed locally or remotely. Collected data are securely saved and transferred to meeting data integrity-related standards such as 21 

The instrument can store up to 10,000 data samples and can be configured for up to 100 users. Unlimited users can access a near field communication card (10).

1. Refeyn, “Refeyn’s New SamuxMP Mass Photometer Promises to Significantly Improve AAV Workflows,” Press Release, Jan. 19, 2021.

2. Bio-Rad Laboratories, “Bio-Rad Introduces Bio-Plex Pro Human SARS-CoV-2 Variant Neutralization Antibody Assays to Quickly Measure Neutralizing Antibodies Against SARS-CoV-2 Virus,” Press Release, Dec. 20, 2021.

3. BioChromato, “Fast & Effective Evaporator Improves Bioremediation Sample Preparation,” Press Release, Nov. 26, 2021.

4. Specifica, “OpenEye Scientific And Specifica Partner To Launch Orion Antibody Discovery Suite Incorporating AbXtract,” Press Release, Dec. 2, 2021.

5. BioPharm International, “MilliporeSigma Unveils ColorWheel Flow Cytometry Portfolio,” 

6. Sartorius, “Sartorius Introduces Faster, Higher Capacity Sartolab RF|BT Vacuum Filtration Units,” Nov. 1, 2021.

7. Thermo Fisher Scientific, “Thermo Fisher Scientific Launches
New Mass Spectrometry and Chromatography Solutions at ASMS 2021,” Press Release, Nov. 1, 2021.

8. CuriRx, “CuriRx Launches CuriLytics Platform to Provide CMC Analytical Services to Support Complex Biotherapeutic Development Using High Resolution Mass Spectrometry,” Press Release, Sep. 21, 2021

9. Pharmaceutical Technology, “Hydrogen Peroxide Dispensing System” 

10. Pharmaceutical Technology, “Airborne Particle Counter,” 

An overview of technologies aiming to improve laboratory processes from the past year.

Lab Operations Improvements

A new collection of caps, vials, inserts, kits, well plates, and mats from Thermo Fisher Scientific is intended to improve analytical performance and sample security for chromatography and mass spectrometry users in routine and research laboratories. The new consumables are applicable in both the pharma and biopharma sectors as well as across the clinical, food, environmental, and academia sectors.

Launched under the Thermo Scientific SureSTART portfolio in February 2022, the new consumables are compatible with all add-on and chromatography autosamplers, allowing analysts to use the new portfolio regardless of instrument vendor, according to a Feb. 21, 2022, company press release. The new collection provides sample security and low compound adsorption, even for challenging, low-level analytes, which provides laboratories with confidence in results and reduces the time needed for reviewing background peaks or identifying analytes that have shifted retention times.

The SureSTART product line draws from existing products that have been historically successful in the market. The collection aims to provide precise and consistent measurements between different vials and different lots.

“As a trusted provider of vials, closures, and well plates, we continue to innovate to offer laboratories the improved flexibility and assurance needed to meet analytical requirements,” said Detlev Lennartz, product manager, sample handling, chromatography and mass spectrometry, Thermo Fisher, in the press release. “SureSTART consumables are built from high-quality materials that meet both the performance and price requirements of our customers, providing the confidence they need to analyze challenging analytes. Additionally, the new collection is fully compatible with GC [gas chromatography], GC–MS [gas chromatography mass spectrometry], LC [liquid chromatography] and LC–MS [liquid chromatography mass spectrometry] analytical instruments and includes three performance levels to help laboratories choose the right product for their experimental needs.”

New Technology

A new portfolio of chromatography and mass spectrometry consumables launched by Thermo Fisher Scientific is designed to meet higher performance requirements while remaining economical.

Thermo Fisher Scientific Introduces New Portfolio of Chromatography and Mass Spectrometry Consumables

Taconic Biosciences, a provider of drug discovery animal model solutions, announced its Cage+ product on Feb. 21, 2022. Cage+ is a holistic colony management model that is intended to offer comprehensive coverage for contract breeding services.

According to a company press release, project planning and management burden is often placed on investigators, who likely do not have the time or expertise to design and manage scaled production of complex animal models. Cage+ is meant to provide a solution to this, as it applies a holistic approach that combines standard animal breeding and husbandry elements with breeding design expertise, project-specific methodology, budget monitoring, and proactive project management and communication.

Uses expert-led embryology methods to expand breeding production

Delivers internationally harmonized animal health standards

Includes the eTACONIC web-based project management tool, which provides users 24/7 access to colony information.

“Researchers should demand better from contract breeding service providers, and this view is the driving factor behind our Cage+ stewardship-based approach to colony management solutions,” said John Couse, vice-president, scientific services, Taconic Biosciences, in the press release. “With Cage+, researchers will view Taconic as an extension of their team, leveraging the collaboration of scientists and experts. Our approach allows investigators to focus their time, energy, and resources on research while trusting their custom model animal development and production to Taconic.”

News

Taconic Biosciences Cage+ colony management service aims to offer comprehensive coverage for contract breeding services.

Taconic Biosciences Launches Cage+ Contract Breeding Service

MilliporeSigma announced a collaboration between its life science business sector and Waters with the aim of building and expanding an extractables and leachables (E&L) reference library to include ion mobility measurements.

According to a Feb. 15, 2022, press release, the library will enable analytical labs to use Waters’ ion mobility-enabled liquid chromatography mass spectrometry (LC–MS) instruments to identify potential extractables and leachable compounds. The identity and quantity of these compounds will then be confirmed through MilliporeSigma’s Supelco reference materials.

Per the terms of the agreement, Waters will use high-quality analytical standards and reference materials from MilliporeSigma to build and expand an E&L library of collision cross-section (CCS) values for Waters’ LC–MS instruments. The library will be available for download from the Waters Marketplace (login required) and cross-linked to the MilliporeSigma business sector online product catalog to provide users access to reference materials to confirm their results.

“Accurate screening for extractables and leachables is imperative to ensuring consumer safety, especially in pharmaceuticals, food packaging, or medical devices,” said Heike Petri, head of Advanced Analytical and Industrial & Testing, Life Science business sector, Merck KGaA, Darmstadt, Germany, in the press release. “This collaboration will provide manufacturers with unrivalled confidence in their results, help improve workflow efficiency for labs, and ultimately contribute to consumer safety.”

MilliporeSigma and Waters will work together to build an extractables and leachables (E&L) reference library.

MilliporeSigma Announces E&L Reference Library Collaboration with Waters

PETA scientist Jeffrey Brown of PETA Science Consortium International e.V. released a statement on Feb. 17, 2022 regarding new FDA Commissioner Dr. Robert Califf. The Science Consortium asked Califf in a letter to aid in steering the agency toward the use of animal-free science in place of requiring animal testing for new medical treatments. Califf expressed support for a shift toward the use of animal-free testing during his confirmation hearings.

“During your confirmation hearings, we appreciated your support for shifting toward the use of non-animal methods to enable more efficient pre-clinical development and evaluation of new drugs and devices,” Brown stated in the letter to Califf. “A reaffirmed commitment to demonstrate the FDA’s support of modern approaches to safety and efficacy assessment without the use of animals will generate a more human-relevant understanding of toxicity and efficacy while expediting the availability of treatments to patients.”

The organization highlighted its hope that Califf will support the FDA Modernization Act, which would change the FDA’s rules that require deadly tests on animals, including mice, dogs, and monkeys. The organization also believes Califf’s previous experience as FDA commissioner will benefit the advancement of animal-free science and testing.

PETA Science Consortium International e.V. and PETA scientist Jeffrey Brown share goals with new FDA Commissioner Dr. Robert Califf.

PETA Science Group Shares Goals With New FDA Commissioner

FDA’s Center for Drug Evaluation and Research announced a new virtual workshop slated to happen on March 23–24, 2022. The public meeting, “Identification of Concepts and Terminology for Multi-Component Biomarkers,” will be held to discuss high-level terminology surrounding biomarkers.

According to an FDA press release, the goal of the symposium is to develop multi-component biomarker concepts and terminology, identify areas of conceptual language development, and discuss gaps in terminology for concepts and approaches as it relates to multi-component biomarkers.

The symposium will be held via live webcast for the public from 1:00–3:00 pm ET on both days. A full breakdown of the events schedule can be found 

. The public will also gain access to additional pre-recorded talks three weeks prior to the live event, which FDA recommends viewing ahead of the event.

FDA will hold a symposium discussing the identification of concepts and terminology for multi-component biomarkers from March 23–24, 2022.

FDA to Hold Public Symposium on Multi-Identification Biomarkers

The European Patent Office has granted another patent to Salipro Biotech, a Swedish biotech company, covering the composition-of-matter, methods, and uses of the company’s novel antigen technology.

According to a Feb. 8, 2022 press release, the “Antigen and method for production thereof” patent (No. EP 3 043 814 B1) will strengthen Salipro Biotech’s proprietary platform technologies to enable the discovery and development of next-generation therapeutics against challenging drug targets.

“We’re constantly increasing our collaborations, partnerships and licensing agreements with major pharma companies on a wide range of challenging drug targets,” said Maria Knudsen, business development director at Salipro Biotech AB, in the press release. “Expanding our already strong patent portfolio further will enable us to increase the value of such collaborations for our partners as well as moving towards building our own discovery pipeline.”

“We’re excited about this important milestone that provides additional protection for our core technologies. The market for therapeutic antibodies, vaccines and biologics is ever expanding,” added Jens Frauenfeld, CEO, Salipro Biotech, in the press release. “Securing these patents protects our innovative platform and further strengthens our position by supplementing our foundational and follow-up patents that have already been granted to Salipro Biotech in many countries, including US, [European Union], China, and Japan.”

The European Patent Office has granted another patent to Salipro Biotech,  covering the composition-of-matter, methods, and uses of the company’s novel antigen technology.

Pharmaceutical Technology's In the Lab eNewsletter, March 2022