MicroCal PEAQ-DSC Automated

Gold standard protein stability analysis for the regulated environment

The MicroCal PEAQ-DSC Automated system delivers high throughput, highly sensitive protein stability analysis with low sample consumption, in an automated, integrated platform for increased productivity.  All cell filling and cleaning functions are fully automated for walk-away operation.

Data generated by the MicroCal PEAQ-DSC Automated provide critical guidance for biopharmaceutical development in protein engineering, (pre)formulation development, process development, manufacturing change control and biosimilarity and biocomparability studies. Unattended operation enables 24-hour screening, while the integrated software streamlines workflows, facilitates non-subjective data analysis, performance qualification and compliance with 21 CFR Part 11 and Annex 11 regulations, all delivering high integrity data and driving productivity in biopharmaceutical research.

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Features and benefits

Differential Scanning Calorimetry (DSC) is a powerful analytical tool for characterizing the thermal stability of proteins and other biomolecules. The technique measures the enthalpy (ΔH) and temperature (Tm) of thermally-induced structural transitions of molecules in solution. This information provides valuable insights into factors that stabilize or destabilize proteins, nucleic acids, micellar complexes and other macromolecular systems. The data are used to predict shelf-life of biomolecular products including biopharmaceuticals to enable batch-to-batch and biosimilar versus innovator molecule comparisons, to develop purification strategies, to characterize and evaluate protein constructs, and to rank the affinities of ligands to their protein targets in small molecule drug discovery programs.

The high-throughput, high-sensitivity MicroCal PEAQ-DSC Automated system features software that streamlines workflows through simplified experimental setup and flexible instrument scheduling. Automated data analysis supports the generation of high integrity thermal stability data and delivers compliance with regulatory requirements, whilst allowing easy integration into existing data handling and transfer systems.

Key Features

  • Gold standard stability-indicating technique requiring minimal assay development 
  • Direct and label-free measurement of biomolecular native-state stability in solution 
  • Standard 96-well plate format for high capacity and easy loading, with thermostatically-controlled storage of up to 6 plates
  • Fully integrated autosampler enables unattended analysis of up to 50 samples per day
  • Automated cell filling and cell cleaning functions permit unattended operation 
  • Measurement of very tight binding constants, up to 1020M-1
  • Powerful MicroCal PEAQ-DSC software minimizes typical data analysis time and includes:
    • PEAQ-Compliance: The system is available with Malvern Access Controller (MAC) to limit access to user-defined SOPs and data analysis features. Data can be displayed using the Report Generator with user details and the ability to sign using electronic signatures to facilitate the integration of the workflow into your company’s quality system and aid compliance with 21 CFR Part 11 and Annex 11 regulations. This is provided as an optional accessory
    • PEAQ-Performance: Automatically detects and validates system readiness for optimal performance
    • PEAQ-Smart (including PEAQ-Finder): For SOP-based operation and data analysis.  Provides new algorithms to detect even subtle peaks and shoulders, facilitating the automatic, non-subjective identification of multiple transitions, such as those seen in multi-domain proteins
    • PEAQ-Compare: For the quantitative comparison of DSC traces for comparability studies, ideal for batch-to-batch and biosimilarity studies
    • Network-ready: email updates sent during the analysis to keep you informed of assay progress

The MicroCal PEAQ-DSC is also available as a manual system without the autosampler.

How it works

Functional structures formed by proteins and other macromolecules often undergo temperature-induced conformational changes, such as unfolding. These changes result in the absorption of heat as a result of the redistribution of non-covalent bonds within the molecule. Differential Scanning Calorimeters measure this heat uptake very precisely.

The thermal core of the MicroCal PEAQ-DSC Automated system contains a sample cell (containing the sample of interest) and a reference cell (containing a matched buffer solution), both of which are housed within an insulating jacket. These two cells are always maintained at the same temperature, and during a measurement, they are heated at a constant scan rate. 

As the molecule within the sample cell unfolds, heat is absorbed, creating a temperature difference (ΔT) between the sample cell and the reference cell. This results in a thermal gradient across the Peltier units, creating a proportional voltage, which is in turn converted to power to form a feedback loop to the Peltier units, in order to return ΔT to zero.

Since protein unfolding is an endothermic event, it is observed as a positive displacement in the thermogram. The midpoint of this protein ‘melting’ transition is the Tm, and the area under the curve is the enthalpy (ΔH) of the unfolding process (please see figure below).

MicroCal-PEAQ-DSC-Automated-How-It-Works

Data analysis and measured/derived parameters are described in greater detail on the Differential Scanning Calorimetry technology page.

技術指標

General

技术类型 Differential Scanning Calorimetry
测量类型
Temperature midpoint (TM)
Enthalpy (ΔH)
Heat capacity change (ΔCp)

Cell

样品池 Capillary
样品池材料 Tantalum
样品池容积 130 μL

Sample

样品容量 288 (6 × 96-well plates)
样品量 325 µL
典型样本浓度 0.01 mg/mL – 10 mg/mL 1
样品处理量 ≤50 samples/day
样品储存温度范围 4°C - 40°C

System

噪音 0.05 μCal/°C 2
基线可重复性 1 μCal/°C 2
响应时间 5s 2
重复性 <0.2 µCal/°C 3
重现性 <0.08°C St. Dev. TM and <2% RSD on ΔH 4
系统可重复性 <0.1°C St. Dev. TM and <5% RSD on ΔH 4
多重反馈模式 Yes (passive, high gain and low gain)
温度范围 2°C to 130°C 2, 5
最大扫描速率 240°C/h
逆向扫描 Yes
压力扰动量热法 (PPC) N/A
清洗程序 3 pre-programmed routines
清洗溶剂 Water and detergent used as standard

Software

21 CFR 第 11 部分 Yes, with PEAQ-Compliance software option
已连接网络 Yes, with email alert capability

Operating environment

操作温度(°C) +10°C to +28°C
储存温度 -20°C to +50°C
湿度 10% to 70%, non-condensing (10% to 90% for storage)
(IP) 等级 IP21
电源功率 100-240 V A/C, 50/60 Hz, 70 W (cell), 400 W (max, autosampler), PC as supplied
认证 CE (EN61010-1), EMC (EN61326-2-1, EN61326-1, FCC, ICES, VCCI), ISO9001:2008

Weight and dimensions

尺寸 (宽, 长, 高): 101 cm × 68 cm × 70 cm
重量 Approx. 25 kg

Notes

1 Sample dependent

Typical results for ribonuclease (RNase) in 50 mM KAc buffer at pH 5.5, at 60°C/h with high feedback

3 Rescans of a stable buffer

4 Using ribonuclease (RNase)

5 Range may be extended down to -10°C upon request

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Key Applications

Biotherapeutic Discovery, Development and Manufacturing

The MicroCal PEAQ-DSC Automated is trusted throughout the biopharmaceutical industry to provide valuable stability data for biotherapeutics in discovery, development and manufacturing. This is because of the universal nature of the detection method, the ability to detect very subtle changes in the conformation of biologic drugs and the high reproducibility of the data. 

Webinar: Solve stability problems in preformulation and process development using DSC 

Application note: Using Differential Scanning Calorimetry to accelerate liquid formulation development for protein biopharmaceuticals 

Biosimilarity and Biocomparabilty

The highly reproducible nature of the MicroCal PEAQ-DSC instruments and the ability of the technique to detect even changes to a single amino acid in a protein have been the core drivers behind the use of DSC data in submissions for approval for biosimilar drugs. The MicroCal PEAQ-DSC software has a biosimilarity tool for statistical comparison with the innovator drug.

Whitepaper: Characterization of biopharmaceutical stability with Differential Scanning Calorimetry: Biosimilarity and batch-to-batch comparability 

Characterization of Antibody Drug Conjugates and Vaccines

DSC, DLS and other biophysical technique can be used to study the stability of Antibody Drug Candidates and the effects of antibody drug ratios on their stability and propensity to aggregate. The example below also show how DSC can be used to measure the kinetics of inactivation by heating over a broad range of scan rates.

Webinar: Biophysical and stability characterization of antibody-drug conjugates  

In the current state DSC is one of the key approaches to the successful development of biopharmaceuticals

Sorina Morar-Mitrica, Ph.D — GlaxoSmithKline