SCIEX Expands BioPhase 8800 Capabilities to Support Faster, More Automated CE Workflows
SCIEX, a Danaher company and a provider of analytical technologies for the life sciences, has announced new capillary electrophoresis (CE) capabilities for its BioPhase 8800 system. The latest enhancements are designed to help laboratories accelerate drug development timelines, strengthen compliance, improve laboratory automation, and expand analytical capabilities for emerging oligonucleotide-based therapeutics.
The updates combine enhancements to the BioPhase software, new automation connectivity through an instrument application programming interface (API), and an expanded analytical kit for the characterization of longer single-stranded oligonucleotides. Together, the new capabilities are intended to give scientists greater flexibility as they move from research and development activities toward data-driven development decisions.
SCIEX said the additions address several priorities facing modern analytical laboratories, including the need to increase throughput, maintain data quality, meet regulatory expectations and integrate analytical instruments into increasingly connected laboratory environments.
The new capabilities include BioPhase software 1.6, the BioPhase Instrument API and the Oligo 200 nt Purity and Integrity kit.
BioPhase Software 1.6 Strengthens Regulated Workflows
One of the key additions is BioPhase software 1.6, which provides laboratories with expanded tools intended to support drug development and regulated analytical workflows.
The updated software gives laboratories greater flexibility to introduce additional controls when needed to align analytical processes with regulatory requirements. Among the features included in the latest software version are user management, audit trails, electronic signatures and project management tools.
These functions are particularly relevant for laboratories working in regulated environments, where analytical data must be managed through controlled processes and where organizations may need to demonstrate who performed an activity, when it occurred and whether data or methods were modified.
User management can help laboratories establish appropriate access controls, while audit trails provide a record of relevant activities within the software environment. Electronic signatures can support controlled approval processes, and project management functionality can help laboratories organize analytical work across development programs.
As pharmaceutical and biotechnology organizations move more laboratory activities into digital environments, analytical software is increasingly expected to provide not only instrument operation capabilities but also tools that support data governance and compliance. BioPhase software 1.6 is designed to address these requirements while maintaining flexibility for scientists during drug development.
BioPhase Instrument API Enables Automation Integration
SCIEX has also introduced the BioPhase Instrument API, which is designed to connect the BioPhase 8800 system with broader laboratory automation environments.
The API allows external software applications to interact with the BioPhase 8800 system through a range of functions. These include remote sequence execution, real-time instrument monitoring, instrument control and automated data acquisition.
Laboratory automation is becoming increasingly important as pharmaceutical development organizations seek to increase throughput and reduce manual intervention in repetitive analytical processes. Connecting analytical instruments to automation platforms can allow laboratories to coordinate sample preparation, analysis, data collection and other workflow steps more efficiently.
By providing an interface between the BioPhase 8800 system and external software, the BioPhase Instrument API is intended to make it easier for laboratories to incorporate CE analysis into connected laboratory environments.
The capability can also support real-time visibility into instrument status and analytical operations. Such connectivity may help laboratories coordinate workflows across multiple systems and reduce the need for scientists to manually initiate or monitor individual instrument processes.
SCIEX said the BioPhase Instrument API expands the ability of customers to incorporate the BioPhase 8800 into automated workflows while maintaining access to instrument control and data acquisition functions.
Expanded Support for Oligonucleotide Analysis
Another major component of the launch is the Oligo 200 nt Purity and Integrity kit. The new kit expands SCIEX CE workflows for high-resolution analysis of single-stranded oligonucleotides extending to more than 200 nucleotides.
Oligonucleotide-based medicines have become an important area of biopharmaceutical research and development. These molecules can be used in a variety of therapeutic approaches, creating analytical challenges related to sequence, size, purity, integrity and other product characteristics.
The ability to characterize longer oligonucleotides with high-resolution analytical methods can be important during development and quality assessment. SCIEX said the new kit supports analysis of single-stranded oligonucleotides up to 200+ nucleotides and can be used for characterization applications including mRNA poly(A) tails.
Poly(A) tails are an important feature of many mRNA-based therapeutics because their characteristics can influence the stability and translation of mRNA molecules. Analytical characterization of these structures can therefore provide information relevant to understanding product quality and performance.
The Oligo 200 nt Purity and Integrity kit is intended to expand the range of oligonucleotide applications supported by the BioPhase 8800 platform. SCIEX is positioning the capability as part of its broader effort to provide analytical solutions for emerging therapeutic modalities.
Supporting the Shift Toward Faster Development
The pharmaceutical industry is increasingly focused on shortening development timelines while maintaining rigorous analytical standards. As drug candidates move through discovery, development and manufacturing stages, laboratories must generate reliable analytical data while managing increasingly complex workflows.
Jose Castro-Perez, vice president of product management at SCIEX, said customers are seeking ways to accelerate development while maintaining confidence in data quality, compliance and scalability.
According to Castro-Perez, the latest BioPhase 8800 capabilities are intended to strengthen support for regulated workflows, enable deeper integration with laboratory automation and broaden analytical coverage for emerging oligonucleotide therapeutics.
The combination of software controls, automation connectivity and expanded analytical applications reflects the changing needs of laboratories involved in biopharmaceutical development.
Rather than functioning solely as an analytical instrument, the BioPhase 8800 is being developed as part of a broader laboratory workflow. Software tools can support data management and compliance, API connectivity can facilitate automation, and application-specific kits can help scientists address new classes of therapeutic molecules.
Capillary Electrophoresis in Biopharmaceutical Development
Capillary electrophoresis is an analytical separation technique used to characterize a range of biological molecules and pharmaceutical products. The technique separates molecules based on properties such as charge and size, allowing researchers to assess different components within a sample.
In biopharmaceutical development, CE can be applied to areas including protein characterization, impurity analysis and nucleic acid analysis. Its role can become particularly relevant as developers work with increasingly complex therapeutic modalities.
For oligonucleotide products, analytical methods must be capable of distinguishing closely related molecular species. This can include full-length products and shorter or modified species generated during synthesis or other processing steps.
High-resolution separation can therefore contribute to assessments of product purity and integrity. The expansion of the BioPhase 8800 workflow to longer oligonucleotides reflects the growing analytical requirements associated with nucleic acid-based therapeutics.
SCIEX’s new Oligo 200 nt Purity and Integrity kit is designed to provide laboratories with additional capabilities in this area, extending analytical coverage to single-stranded oligonucleotides reaching beyond 200 nucleotides.
Connecting Analytical Instruments With Digital Laboratories
Automation and digital connectivity are becoming increasingly important components of pharmaceutical laboratory infrastructure. Laboratories may use multiple instruments and software systems across a single development program, creating demand for technologies that can communicate with one another.
The BioPhase Instrument API is intended to address this requirement by allowing external applications to communicate with the BioPhase 8800.
Remote sequence execution can help integrate analytical runs into automated workflows, while real-time monitoring can provide visibility into instrument operations. Instrument control and automated data acquisition further expand the potential for hands-off or partially automated analytical processes.
For laboratories managing larger sample volumes, these capabilities may help reduce manual steps and improve workflow consistency. They can also support integration with broader laboratory automation strategies.
The ability to connect analytical instruments to automated environments is particularly relevant as organizations explore ways to increase laboratory productivity without proportionally increasing manual workload.
Compliance and Data Management
Regulatory compliance remains a critical consideration in pharmaceutical and biotechnology laboratories. Analytical results may ultimately contribute to decisions concerning product development, manufacturing and quality, making data integrity and traceability essential.
BioPhase software 1.6 addresses these needs through features including audit trails, electronic signatures and user management.
Such capabilities can help laboratories establish controlled analytical environments and maintain records associated with instrument and software activities. Project management tools can also provide organizational support as scientists work across multiple analytical studies and development programs.
SCIEX’s focus on these capabilities reflects the need to combine analytical performance with the software and workflow controls required by modern regulated laboratories.
SCIEX to Highlight New Capabilities at CE Pharm
SCIEX is also scheduled to present its latest CE capabilities during CE Pharm, including a technical session focused on expanding pipeline capabilities for its CE portfolio.
The SCIEX technical session is scheduled for Monday, September 28, 2026, from 12:15 p.m. to 1:15 p.m. ET in the Plaza Ballroom Foyer. The session is titled “Trusted foundation, expanded possibilities: Expanding pipeline capability for SCIEX CE with BioPhase software. Single-nucleotide-resolution separation of oligonucleotides up to 141 nt.”
The company will also showcase its BioPhase software 1.6, BioPhase Instrument API and Oligo 200 nt Purity and Integrity kit through its booth, technical seminar and poster sessions at the event.
The technical program provides an opportunity for scientists and laboratory professionals to learn more about the analytical applications and workflow capabilities being developed for the BioPhase 8800 system.
Expanding Analytical Capabilities for Emerging Therapeutics
The latest SCIEX announcement reflects the continuing evolution of analytical technologies alongside the development of new pharmaceutical modalities.
Oligonucleotide therapeutics and mRNA-based medicines have created new analytical requirements for pharmaceutical laboratories. At the same time, increasing demand for automation and regulatory-ready data management is changing how laboratories design their workflows.
SCIEX is addressing these trends through three complementary areas: enhanced software functionality, expanded instrument connectivity and new analytical capabilities.
BioPhase software 1.6 provides tools for controlled and regulated workflows. The BioPhase Instrument API is designed to connect the system to automated laboratory environments, while the Oligo 200 nt Purity and Integrity kit expands the platform’s ability to characterize longer single-stranded oligonucleotides.
Together, these enhancements are intended to provide laboratories with a more flexible analytical platform capable of supporting development programs from early research through more regulated stages.
As pharmaceutical developers continue to pursue complex molecules and automated laboratory processes, analytical platforms will increasingly need to combine high-resolution measurement with connectivity, data management and workflow control. SCIEX’s latest BioPhase 8800 capabilities are designed around these requirements, supporting laboratories as they seek to accelerate development while maintaining analytical confidence, compliance and scalability.
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SCIEX, a Danaher company, and leader in life science analytical technologies, empowers customers to solve the most impactful analytical challenges in quantitation and characterization. With groundbreaking innovation and outstanding reliability and support, SCIEX has been at the forefront of the field for over 50 years.
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