Future-proof SPR assay for biologics QC: Method validation and transfer from Biacore™ T200 to Biacore™ 1 series systems using a case study from Solvias

Abstract

The research and drug discovery landscapes are changing, and biologics pipelines include increasingly complex formats such as bispecifics, trispecifics, and antibody-drug conjugates (ADCs). These advanced modalities require robust quality control (QC) assays to ensure critical quality attributes (CQAs) are maintained. Surface plasmon resonance (SPR) remains a method of choice for kinetic, affinity, active concentration, and potency measurements.

The Biacore™ T200 instrument is an SPR-based biosensor system used to analyze biomolecular interactions without labeling. With its discontinuation, laboratories require a reliable successor that ensures continuity for validated methods. Biacore™ 1 series systems build on this established foundation as a next generation one-needle SPR platform, offering faster turnaround, lower sample consumption, enhanced sensitivity, and improved data integrity to support future-ready SPR assays in regulated QC workflows.

This white paper presents a practical, regulatory-aligned approach for transferring and validating SPR assays from Biacore™ T200 to Biacore™ 1 series. Drawing on practical insights from a case study performed by Solvias featuring quantitative assessment of concentration for process-related impurities in a drug substance. This paper highlights considerations for method transfer in Good Manufacturing Practice (GMP)-regulated environments, including platform-specific adaptations and validation parameters to maintain consistent performance. The strategy follows a risk-based approach aligned with international council for harmonization guidelines; ICH Q2(R2) (validation) and ICH Q14 (analytical procedure development), enabling partial or full revalidation for confident migration of validated assays to the new platform.

This paper also provides best practices for assay optimization, validation, and bridging studies, offering a roadmap for laboratories upgrading to Biacore™ 1 series systems. Although this whitepaper focuses on Biacore™ T200 and Biacore™ 1 series systems, the validation and transfer guidance applies to other Biacore platforms (e.g., Biacore™ 8 series systems) with instrument- specific considerations.

Introduction

The evolving biologics landscape

Biotherapeutics represent the fastest-growing segment of the pharmaceutical industry, with global biologics sales reaching approximately $450 billion in 2025 (1) and continuing to expand at double-digit rates. Today, more than 200 biotherapeutic drugs are approved worldwide, and over 1,500 candidates are in clinical trials, including next-generation formats such as bispecifics, trispecifics, and antibody-drug conjugates (ADCs) (Fig. 1). Biosimilars are also gaining momentum, with over 75 approved globally and more than 1,000 in development by 2025 (2). This surge in innovation and competition is driving demand for robust analytical platforms that can ensure product quality and regulatory compliance.

Fig 1. Illustrative overview of biotherapeutic modalities represented across current development pipelines, highlighting the increasing diversity of antibody formats (e.g., ADCs, multispecifics), recombinant proteins, and emerging modalities such as gene therapies and peptides. Data shown reflects industry trends reported in public pipeline analyses, not exact counts. Source: Global Data May 2025.

As molecular complexity increases, so does the need for advanced, information-rich analytics to monitor CQAs throughout development and manufacturing. These analytics are essential to guarantee purity, efficacy, and safety, supporting both innovative biologics and biosimilars in a highly regulated environment.

Adoption of Biacore™ SPR for CQA analysis and industry trends

Surface plasmon resonance (SPR) has become a cornerstone analytical technology in biopharmaceutical development and quality control (4, 5). It is increasingly cited in regulatory filings for biologics, approximately 60 marketed biologics have utilized SPR during filing (Cytiva internal data 2026) highlighting its critical role in demonstrating mechanism of action through robust structure–activity relationship (SAR) analysis of drug–target interactions.

Biacore™ systems offer key advantages that make them indispensable for CQA analysis in QC workflows:

• Regulatory compliance: SPR is included in major pharmacopoeias (USP, Ph. Eur., JP) (6, 7).
• Label-free interactions: Real-time measurements with high sensitivity eliminate labelling, preserving native molecule behaviors.
• High-quality data: Outstanding reproducibility and consistent results ensure reliable decision-making.
• Automated workflows: Reduced hands-on time improves efficiency and minimizes operator variability.

These capabilities enable Biacore™ SPR systems to support critical assessments such as binding activity, active concentration, potency, comparability studies, and detection and quantitation of impurities, ensuring robust characterization throughout drug development and manufacturing. These capabilities make Biacore™ SPR highly applicable to today’s fast-growing biologics market, including biosimilars, which rely heavily on detailed functional characterization.

Biosimilar studies often include SPR-based functional assays alongside cell-based bioassays to demonstrate equivalence, reinforcing FDA approvals under the totality-of-evidence framework. This trend reflects growing regulatory confidence in advanced binding analytics for QC release. The recent FDA draft guidance (8) further strengthens this approach by signaling a shift away from routine comparative efficacy studies (CES) toward a comparative analytical assessment (CAA) anchored in advanced structure–function analytics (9). When supported by pharmacokinetic (PK) similarity and immunogenicity assessments, CAA can replace CES in many cases. This elevates high-sensitivity binding analytics such as Biacore™ SPR as a cornerstone of biosimilarity evaluation within the totality-of-evidence framework.

Beyond regulatory filings, patent applications increasingly reference SPR data to substantiate claims for novel biologics and complex modalities such as bispecific antibodies, Fc-engineered variants, and ADCs, underscoring their strategic role in intellectual property protection and regulatory submissions.

This dual adoption by regulators and innovators positions Biacore™ SPR as a logical choice for QC teams seeking pharmacopeia-recognized, validated, and transferable assays that align with evolving regulatory expectations and competitive industry demands.

Critical quality attributes in QC and manufacturing

Critical quality attributes (CQAs) are physical, chemical, and biological properties that should be within an appropriate limit or distribution to ensure the desired product quality. CQAs are the foundation of regulatory compliance in biopharmaceutical development and manufacturing. They include both product-specific and process-related attributes, such as target–receptor interaction data, protein integrity, homogeneity, host cell proteins (HCP), host cell DNA, and leachables from process or packaging materials.

In this context, Biacore™ SPR technology provides detailed characterization of CQAs (Fig. 2), including active concentration, potency, kinetics (k_a, k_d), affinity (K_D), epitope specificity, and comparability (3, 4). It also supports stability and degradation studies, biosimilarity assessments, and batch-to-batch consistency by comparing interaction parameters across lots.

Fig 2. CQAs in biotherapeutics development and manufacturing. Biacore™ systems are typically used for binding activity, concentration measurements, potency, and comparability studies.

Method validation and transfer of Biacore™ assays

Validation of Biacore™ methods

Once a Biacore™ SPR method is developed , which covers ligand selection and coupling strategy, identification of analyte injection and regeneration conditions, and data fitting, the next critical step is validation, which converts the method into a robust, documented process suitable for QC and regulated environments. In practice, this means:

Fix the design space and controls

• Finalize critical method parameters (CMPs) such as surface density ranges, contact time, flow rate, temperature, regeneration, etc.
• Define system suitability tests using reference materials (positive control, negative control), with clear acceptance criteria (e.g., %CV, RU ranges).

Establish reference materials and traceability

• Select a reference standard and a working standard, document their qualification, storage, and requalification intervals.
• Set rules for lot bridging (e.g., new ligand lot, chip lot, or reagent lot) to maintain continuity of potency and binding readouts.

Stress and boundary testing before formal validation

• Check surface stability (baseline drift, carry-over) and confirm regeneration robustness.
• Assess matrix effects after ligand coupling and define mitigation (blank subtraction, parallel reference flow cell).

Model and analysis readiness

• Preselect fit models and goodness of fit criteria.
• For surrogate potency/EC₅₀, lock curve fit settings (e.g., four-parameter logistic [4PL] curve) and define how outliers are handled.

Documentation, data integrity, and training

• Issue a pre approved validation protocol (objectives, parameters, runs, statistics, acceptance criteria) and run according to GxP and 21 CFR Part 11 expectations.
• Ensure the evaluation workflow (e.g., Biacore™ Insight method templates, audit trails, versioned methods) is locked, train analysts and document competency.
• Implement change control for chips, sensor surfaces, buffers, and software versions; define when partial vs. full revalidation is required.

The method validation is essential for Biacore™ SPR assays to ensure reliability and robustness, particularly during assay transfer from a legacy system to a new platform. Key parameters such as specificity, precision, accuracy, linearity, range, detection limit, quantitation limit, and robustness form the foundation of regulatory compliance and data integrity. These parameters safeguard against variability and ensure the method remains fit for purpose throughout its lifecycle.

In Biacore™ SPR based QC assays, the coefficient of variation (CV) is routinely used to demonstrate assay precision and control. CV values reflect the combined performance of sensor surface stability, injection reproducibility, analyte response, and data evaluation. Consistently low CVs across replicate injections and independent runs provide confidence that binding responses and derived parameters, such as active concentration, potency, or affinity are suitable for method validation and transfer.

Table 1. Summarizes the critical validation parameters, explains their relevance in Biacore™ SPR workflows, and provides practical recommendations for implementing them during method validation and transfer.

Comparison of Biacore T200 and Biacore 1 series system

Although Biacore T200 and Biacore 1 Series operate on the same SPR principle and support same applications, Biacore 1 Series introduces several improvements, including updates to the optical system with a new light source and a redesigned flow cell architecture and flow system. These improvements enhance performance and robustness while preserving compatibility with established SPR workflows.

Table 2. Comparison of system capabilities of Biacore™ T200 with Biacore™ 1S+ (10).

In Biacore™ 1 series systems, the light source is different compared to Biacore T200 systems, resulting in 20% lower absolute response levels. Biacore™ 1 series systems flow cell design has improved robustness and the six flow cells in series provide more analysis options. The mass transfer is slightly slower in Biacore™ 1 series system compared to, for example, Biacore™ T200 system. For mass transport-limited assays, this results in a slightly longer duration to equilibrium. There is no impact on equilibrium response levels.

Regulatory expectations for method transfer

Regulators expect fit-for-purpose analytical procedures with clearly defined acceptance criteria and validation protocols. The International Council for Harmonization (ICH) guidelines Q2(R2) on Validation of Analytical Procedures and Q14 on Analytical Procedure Development emphasize science- and risk-based development, lifecycle management, and, where applicable, partial or full revalidation upon method transfer (11-13). Method transfer validation typically covers specificity, accuracy and precision, linearity, and robustness. These parameters ensure that Biacore™ SPR assays remain compliant and reliable when migrated to new platforms, supporting regulatory submissions and QC workflows.

Risk-based method transfer strategy

Transferring Biacore™ SPR assays from a legacy system (e.g., Biacore™ T200) to a new platform (e.g., Biacore™ 1 series system) requires a structured, risk-based approach to maintain compliance and data integrity. This strategy focuses on identifying potential risks introduced by platform differences and tailoring validation depth accordingly.

Key steps and best practices

Risk assessment

• Identify differences between systems (e.g., performance, sensitivity, detection limits, etc).
• Evaluate impact on critical assay attributes such as kinetics, potency, and concentration.

Define validation scope

• Apply partial or full revalidation based on risk level.
• Prioritize parameters most affected by platform changes (e.g., precision, robustness).

Bridging studies

• Run side-by-side comparisons on both platforms using representative samples.
• Assess equivalence for key metrics (k_a/k_d, K_D, EC₅₀, active concentration).

Documentation and compliance

• Align protocols with ICH Q2(R2) and Q14 principles.
• Maintain traceability and audit-ready records for regulatory submissions.

Bridging studies for assay transfer

Bridging studies are essential when transferring SPR assays from a legacy Biacore™ system to Biacore™ 1 series system because they establish equivalence and maintain continuity in regulated analytical workflows. These studies directly compare critical performance attributes between the two platforms to confirm that the new system delivers results consistent with the validated method.

The aim of these studies is to mitigate transfer-related risks by verifying that key assay outputs such as kinetic and affinity constants, potency estimates, and active concentration, remain within predefined acceptance criteria. To achieve this, bridging activities typically assess essential performance parameters including specificity, accuracy, precision, and robustness, ensuring that method behavior is preserved on the new platform. Collectively, these evaluations generate the evidence needed for demonstrating equivalence and determine whether partial or full revalidation is required, enabling confident adoption of Biacore™ 1 series system in GMP- aligned QC environments.

Solvias case study

The analysis of impurities is a critical aspect of GMP in pharmaceutical production to verify the absence of process-related impurities, contaminants, or carry-over substances that may compromise product safety, therapeutic efficacy, or regulatory compliance. Surface plasmon resonance (SPR) is a highly sensitive, label-free, and real-time analytical technique that enables the detection of low-abundance analytes in complex biological matrices. Its capability to monitor molecular interactions with high specificity makes SPR particularly advantageous for impurity quantification.

This case study presents a comparison between data generated using a validated SPR method on the Biacore™ T200 platform — originally developed to quantify a specific process-related impurity in a drug substance (DS) — and the method adapted for Biacore™ 1 series system. The objective is to demonstrate continuity of assay performance and maintain regulatory compliance throughout the platform transition.

Assay design and methodology

This assay is specifically designed to detect and quantify a given protein which is a process-related impurity potentially present in a drug substance (DS) using SPR. Using the method described in Figure 3, an antibody specific to the protein impurity is covalently coupled to the sensor surface, serving as a selective binding agent for the impurity (the analyte). Upon selective binding of the impurity, a change in the surface refractive index is observed, enabling detection and quantitation. This change is directly proportional to the amount of bound analyte, allowing accurate quantitation. The Biacore™ SPR technology allows accurate quantitation even at very low concentrations (picogram range).

Fig 3. Solvias Biacore assay for detecting and quantifying process-related impurities in a drug substance. In this method, a protein ligand (an antibody specific to the impurity) is coupled to Sensor Chip CM5. The drug substance is then injected over the surface to detect and quantify the level of impurity.

To ensure the method is suitable for use in a GMP-regulated environment, a comprehensive validation strategy is applied. The key validation parameters outlined in table 1 are selected based on the method requirements and thoroughly assessed. Together, these parameters establish the assay’s reliability, reproducibility, and regulatory compliance, making it a robust and defensible approach for impurity analysis in biopharmaceutical manufacturing.

Key considerations for a smooth assay transfer from Biacore™ T200 to Biacore™ 1 series system

The transfer of analytical methods from Biacore™ T200 to Biacore™ 1S+ system revealed some unforeseen challenges, emphasizing the need for platform-specific optimization. The main issue observed was a substantial deviation in the spike-recovery results for the reference standard (impurity substance) in the drug substance matrix, with recoveries exceeding 130% for the lowest concentration using Biacore™ 1S+ system. These overestimated recoveries compromised assay accuracy and raised concerns regarding the ability of transferring the method.

Fig 4. The bar chart shows the recovery of spiked samples in DS material across six reference standard levels (5−126 ng/mL) using the validated Biacore™ T200 method. Measurements obtained on the Biacore T200 instrument are compared with results generated on Biacore 1S+ system. Recoveries on Biacore T200 instrument consistently ranged from 90–104%, while Biacore 1S+ system showed higher recoveries, particularly at low concentrations. Note: only one series of concentrations were analyzed on Biacore 1S+ compared to three series on Biacore T200 which has likely partially contributed to the differences in recovery seen between the two instrument platforms.

Although both systems are based on the same SPR technology, differences between Biacore™ T200 and Biacore™ 1S+ systems can lead to observable changes in assay performance. Biacore™ 1S+ system is equipped with a different light source, injection controls, number of flow cells, and sensor response dynamics. These modifications influence signal generation and analyte binding responses, and without the appropriate adjustments, we observed that the method accuracy was reduced.

To verify that the observed high recoveries are independent of the drug substance (DS) matrix, control studies were conducted on Biacore 1 series with the reference standard spiked into the formulation buffer (FB) matrix. The corresponding results are summarized in Figure 5. As the pattern in formulation buffer was almost the same this was evidence that the analysis method needed to be optimized.

Fig 5. The bar chart shows the recovery of spiked samples in drug substance (DS) material and in formulation buffer (FB) across six spike levels (5−126 ng/mL). Overall, recoveries range from approximately 102-135% in DS and 91-124% in FB.

Assay performance after adaptation

To improve the method performance on Biacore™ 1S+ platform, systematic optimization was conducted. Key parameters - such as standard curve settings, injection volumes, and flow rates were fine-tuned (Table 3) to align with the operational characteristics of the new platform. These adaptations helped minimize mass transport-related effects and improve analyte transport to the sensor surface, resulting in more accurate quantitation. As a result, method accuracy was restored and even slightly improved compared with the original validated method on the Biacore™ T200 instrument.

Table 3. List of Biacore run parameters optimized to ensure the method is fit for purpose for method transfer and validation, achieving performance comparable to the Biacore T200 instrument.

Following the method adaptation to Biacore™ 1S+ system, performance metrics showed clear improvements. Recovery values within the validated range, were consistently of 98–105% (Figure 6), confirming the method’s accuracy on the new system.

But the most notable enhancements were in sensitivity. Biacore™ 1S+ system achieved a limit of detection (LOD) of 0.2 RU, a significant improvement compared to the 2.3 RU observed with Biacore™ T200 instrument. This increase in sensitivity allows for more precise detection of low-concentration analytes, which is especially valuable in complex biological samples.

Repeatability and intermediate precision remained stable throughout the transition (Table 4), indicating that the method continues to deliver reliable and reproducible results. These findings support the suitability of Biacore™ 1S+ system for GMP-compliant applications and reinforce its capability to maintain high analytical standards.

This case highlights the importance of understanding the technical differences between Biacore™ systems to appropriately adjust method parameters for the new platform. Doing so ensures consistent and even enhanced analytical performance.

Fig 6. Recovery of spiked material across six concentrations (5−126 ng/mL) comparing Biacore™ T200 with Biacore™ 1S+ SPR system measured before and after method adjustment. Biacore™ T200 instrument showed recoveries between 96−101%, while Biacore™ 1S+ system yielded higher recoveries before adjustment, particularly at low concentrations. After method optimization, the Biacore™ 1S+ system results aligned more closely with those obtained on the Biacore™ T200 instrument.

Comparison of assay performance on Biacore T200 and Biacore 1 series system

Table 4. Summary of key performance characteristics of the validated assay on Biacore™ T200 and Biacore™ 1S+ system.

Both platforms show comparable accuracy and LOQ values, with Biacore™ 1S+ system demonstrating improved repeatability (RSD) and enhanced SPR- based LOD. Biacore™ T200 instrument shows slightly better intermediate precision, while Biacore™ 1S+ system supports a higher number of validated assay cycles. Overall, both systems meet assay performance requirements, with the Biacore™ 1 series system demonstrating improved analytical performance.

This case study performed by Solvias highlights the importance of reevaluated validated methods during platform transfer, as system related differences (e.g., fluidics, injection control, and sensitivity) can impact assay performance. The results further demonstrate that Biacore™ 1S+ system achieves comparable and improved analytical performance when the method is appropriately optimized. It also emphasizes that recovery at low concentration levels should be carefully assessed during method transfer.

Biacore™ GxP support tools

Ensuring compliance and confidence in assay transfer

When transferring SPR assays to new platforms, regulatory compliance and data integrity are as critical as method validation and bridging studies. Biacore™ GxP Package is designed to meet these requirements, providing a comprehensive framework that supports validated workflows and 21 CFR Part 11 compliance (14).

Fig 7. Biacore SPR offers validation of SPR instruments, software and assay reagents with possibility to perform audits.

Biacore™ GxP Package complements method validation and bridging studies by ensuring that the new system operates within a fully compliant environment. This minimizes risk during migration, supports regulatory audits, and provides confidence that transferred methods maintain integrity and traceability. Together, these elements enable seamless adoption of Biacore™ 1 series system in QC and regulated environments.

Key components of Biacore GxP Package

Regulatory compliance and documentation

• Instruments and software compliant with global regulatory expectations.
• Certificate of hardware/software conformance.
• System assessment report for qualification.
• Change control protocols for hardware, software, and consumables.

Validated tools and software

• Design-validated Biacore™ Insight Software with full 21 CFR Part 11 compliance.
• Extensions and tools that simplify SPR assay setup and ensure reliability.
• Stringent production methods and quality control for sensor chips and consumables.

GxP services and support

• IQ/OQ/IPQ (Installation/Operational/Instrument Performance Qualification) services performed by GxP-trained personnel.
• Comprehensive guidelines for GxP users.
• Online validation training courses and free support materials.
• Application support and training to ensure smooth implementation.

Strategic implications for platform transition

With Biacore™ T200 end of service by 2030, laboratories should begin preparing early for method transfer and validation to ensure continuity and long-term readiness. At the same time, evolving regulatory expectations, particularly the FDA October 2025 draft guidance, are shifting biosimilar development (15) toward a greater reliance on analytical evidence. This shift elevates high sensitivity, mechanism of action–linked analytics such as Biacore SPR as essential evidence within the totality of evidence framework for biosimilarity.

Biacore™ 1 series systems offer a reliable, robust alternative, combining improved performance, enhanced automation, and full compatibility with GMP requirements. This makes it a reliable choice for long- term analytical needs. Transitioning to Biacore™ 1S+ system not only ensures continuity but also unlocks significant benefits:

• Higher sensitivity and precision for binding kinetics, affinity, surrogate potency (EC₅₀, 16), and comparability - strengthening analytical capabilities.
• Automated, compliant workflows (including GxP package and 21 CFR Part 11–ready software) that streamline validation, transfer, and QC release.
• Faster turnaround with lower sample consumption, helping shorten timelines and reduce costs while maintaining data integrity.

Enhanced data integrity and automation using Biacore™ Insight Data Integration Extension

The Biacore™ Insight Data Integration Extension in Biacore Insight Software strengthens data integrity and digital connectivity in regulated environments by enabling secure, automated transfer of analytical results to third-party systems. Runs and evaluations can be exported in JSON format through the Biacore™ Insight API, supporting seamless integration with LIMS and other enterprise data platforms. This automation enables centralized data management, company-specific evaluation workflows, and long-term, audit-ready data archiving. Together, these capabilities reduce manual handling, improve traceability, and ensure that Biacore data can be efficiently incorporated into GxP-compliant analytical ecosystems.

Recommended steps for platform transitions

1. Plan the migration from Biacore™ T200 to Biacore™ 1 series system using a risk- based validation strategy aligned with ICH Q2(R2) and ICH Q14.
2. Depending on the method, the validation focus should prioritize the relevant Biacore™ data readouts, which are typically precision, accuracy, linearity/range, and robustness to demonstrate continuity of performance on the new platform.
3. Also, conduct bridging studies to verify equivalence in k_a/k_d, K_D, EC₅₀, and active concentration, as appropriate for the method, providing the comparative data necessary for regulatory submissions.
4. Operationalize compliance via Biacore™ GxP Package (installation qualification/operational qualification [IQ/OQ], Part 11 software, change control, documentation) to ensure audit- ready adoption in QC.

Early validation and method adaptation are key to a seamless platform transition. By proactively addressing platform-specific differences and refining assay parameters, organizations can preserve analytical performance, maintain regulatory compliance, and avoid last-minute risks. This forward-looking approach positions QC teams to meet evolving industry demands with confidence.

Practical recommendations for method transfer

As mentioned, there are differences between the instrument platforms (Table 2). For example, there is a difference in absolute response levels. To account for this difference and to allow for a smooth and consistent transition from Biacore™ T200 to Biacore™ 1 series systems, we recommend the following considerations to ensure method continuity and data comparability.

• Maintain original assay settings as the starting point
  As a first checkpoint, it is recommended to keep all assay parameters identical to the validated method. Most assays are not dependent on actual response levels. Thus, adjust parameters only when required to accommodate instrument performance.
• Apply the 80% target principle for Aim for immobilization levels
  When using Aim for target level coupling, setting the target to approximately 80% of the original response typically provides comparable ligand density in Biacore™ 1 series systems, reflecting differences in light source and response scaling.
  The same approximate 80% guideline can also be applied to manual cutoff levels used in data evaluations, such as sensorgram plots or epitope binning analyses to maintain interpretability across platforms.
• Reassessment before revalidation
  Conduct a reassessment on the new platform to confirm that key assay behaviors, parameters, and performance remain consistent. This helps identify any needed adjustments early and ensures that revalidation efforts stay focused, efficient, and justified.
• Revalidate critical assay steps
  Key assay elements should be revalidated on the upgraded system to confirm reproducibility, sensitivity, and overall method performance. This also provides clear justification for any parameter refinements needed to meet acceptance criteria again.

Conclusions

The transition from Biacore™ T200 to Biacore™ 1S+ system is more than a routine instrument replacement. It represents a strategic opportunity to strengthen analytical performance while maintaining long- term GMP compliance.

This case study highlights that even fully validated methods require careful re-evaluation when transferred between platforms. System-related differences such as changes in light source, fluidics, injection control, and overall sensitivity can influence assay performance and therefore must be reassessed. In parallel, the software was upgraded to Biacore™ Insight Software offering more streamlined workflows. Because the underlying fitting algorithms remain unchanged, the software upgrade has minimal or no impact on analytical results.

By proactively adapting methods to Biacore™ 1 SPR series systems, accuracy, precision, and sensitivity were successfully restored, and even improved, confirming the platform’s suitability for regulated environments.

As Biacore™ T200 SPR system approaches end of life, early planning and anticipation of necessary method adjustments become essential. Investing in a structured transfer process not only safeguards GMP compliance but also supports operational continuity and regulatory readiness, positioning QC teams for success in an evolving biopharmaceutical landscape.