Biologic therapies derived from living organisms have revolutionized the treatment of complex diseases, yet their high development costs are often passed onto patients. Biosimilar drugs offer a promising solution to reduce costs while maintaining therapeutic efficacy. Unlike generic drugs, biosimilars cannot be exact replicas of their reference biologics due to their complex structures, necessitating rigorous testing and regulatory approval. Microcalorimetry, specifically Differential Scanning Calorimetry (DSC), plays a crucial role in this process by assessing the thermal stability of biosimilars to ensure they are structurally similar and perform equally to their reference drugs. In this blog, we examine why testing is crucial in the regulatory process and how instruments like the DSC are helping usher an influx of biosimilars to patients who need them.

Biologic treatments–those sourced from living things like proteins, stem cells, or genetic material–have saved and improved billions of lives. You, or someone you care about, has benefited from their unique ability to tackle some of our trickiest and deadliest diseases, be it insulin to control and treat diabetes, the mRNA vaccines that curbed and reversed the global COVID-19 pandemic, or immunotherapies helping to slow and reverse deadly cancers.

These pharmaceutical breakthroughs have, no doubt, made the world a healthier place, but not without requiring billions of investment dollars in research, development, and commercialization. That cost is ultimately passed on to insurance companies, healthcare providers, and patients themselves. Fortunately, there is a burgeoning solution to curb cost and increase access: Biosimilar drugs.

In this blog, we examine why biosimilars–despite offering comparable benefits to their “generic” small-molecule drug counterparts–undergo a more stringent regulatory process and how testing for thermal stability using Differential Scanning Calorimetry (DSC) is a critical step in ensuring these therapies function safely and effectively when they reach the patients who rely on them to stay alive.

Like generic drugs, biosimilars can be developed and prescribed once their breakthrough name-brand counterparts’ patent expires. Yet there’s one fundamental difference.

• Generic drugs have a small-molecule structure that is an exact copy of the original name-brand version. Think of Advil (the name-brand) and ibuprofen (the generic) or Lipitor and atorvastatin. The ability to reproduce a structurally perfect copy means a far more straightforward approval process. It also allows pharmacies to fill name-brand prescriptions with generic versions without additional testing or regulation.
• Biosimilars are precisely as the name suggests–similar versions to their name-brand biologic. Because they are sourced from living components, their structures are enormously complex. A perfect copy is impossible. That means, even if their treatment efficacy is the same, they require far more stringent testing and regulation before reaching the market. In particular, if the developer wants to create a therapy that will safely replace or interchange with the original treatment under the same prescription.

Both biosimilars and generics provide similar benefits to patients. More options mean easier access and lower cost. Yet a biosimilar’s journey from lab to patient is more complicated, which is why there are far fewer in the market.

Global regulatory agencies require a biosimilar to meet a specific set of criteria before entering the market. Despite not being molecularly identical to their name brand, a biosimilar must:

1. Use the same “mechanism of action:” The way in which the biosimilar interacts with, controls, or fights the illness must be identical to the original drug.
2. Use the same “route of administration:” If the original is administered through an injection, a patch, or a pill, the biosimilar needs to be delivered through identical means.
3. Be manufactured with a similar potency, purity, and dosage: The biologic’s efficacy can’t rely on more or less treatments or volume.
4. Undergo clinical trials to approve efficacy: However, this process is faster and less strenuous because the original biologic has already endured rigorous study. Which, of course, is why biosimilars are more affordable.

The goal, ultimately, is to ensure the biosimilar performs as well as its counterpart so that, even though it is slightly different at the micro level, it still provides the same effective treatment. But getting there doesn’t just require human trials; testing the formulation’s structure and stability in the lab is a critical early step.

In the past 15 years, countries worldwide have adopted similar regulatory processes to develop, test, and approve biosimilar drugs. Each includes an “Analytical Similarity Assessment“: a series of independent lab tests to prove that the structural properties of the biosimilar closely match the name brand.

‘Conformational Stability” is a fundamental component of the assessment. This tests how the drug’s structure changes through varying temperatures, time, or both. Researchers commonly use a specialized instrument called a Differential Scanning Calorimeter (DSC) to capture the necessary data for the assessment. The tool allows researchers to examine how multiple samples of a given compound transform or react to minute, precisely controlled temperature changes. To be considered a biosimilar, a new therapy must react to heat in the same way as the original biologic. Tools like the Nano DSC offer automated throughput and the highest level of measuring sensitivity to extract vital data during the regulatory process for low dose antibody drug products. Which means it is highly likely, and increasingly necessary, that the biosimilar drugs used in treatment today underwent some form of DSC testing.

The one disadvantage of traditional DSC instruments is that high concentration drug products require dilution to avoid damaging a fixed cell. The new TA Instruments RS-DSC solves this by using disposable micro fluidic chips, allowing for formulations with concentrations >20 mg/mL to be tested in their natural state, quickly and at scale. Ultimately, this provides the most accurate thermal stability data possible while mimicking real-world conditions.

Even if a biosimilar is approved, one additional regulatory hurdle must be surmounted for ubiquitous accessibility. In an ideal scenario, a biosimilar could be swapped for the original biologic at any time during the treatment (if, say, there is a shortage of the name-brand option or the cost becomes prohibitive).

When this option is available, the biosimilar has been approved for “interchangeability.” The drug has undergone human clinical trials and significant lab testing to ensure it behaves precisely the same way as its peer. This additional process differs from generic small-molecule drugs. Because they are functionally identical to their originals, this extra approval isn’t necessary.

But a biosimilar drug’s stability and efficacy can sometimes change, even when stored in the exact same conditions. Which is why testing, at the micro level, how and why the formulation changes compared to the name brand is critical. That can only be done prior to the human trial in a lab using a bevy of instruments, including DSC.

When more biosimilars reach commercialization, global healthcare becomes more accessible and equitable. It’s great news, then, that expiring patents and development innovations will ensure an influx of biosimilars in the near future. But the stringent, regulated process required before reaching patients is vital. Testing, whether done during human trials or earlier in the lab using DSCs along with other instrumentation, ensures that no matter where the treatment comes from, it’s as safe and effective as the blockbuster drug that inspired it.

The stability of high-concentration drugs can change under storage conditions, but until now, thermal testing in the lab using traditional calorimetry methods has been time-consuming and challenging. The new TA Instruments RS-DSC fills a critical antibody formulation development gap by allowing for high-throughput short-term thermal stability testing at formulation strength concentrations. In this blog, we explore why that’s essential.

Subcutaneous injection has revolutionized how billions of patients receive the crucial treatments that keep them alive. From a regular dose of insulin to treat diabetes to the monoclonal antibody adalimumab that regulates rheumatoid arthritis, the ability to self-administer these life-saving therapies provides enormous benefits for both patients and healthcare providers, saving time, money, and resources.

To be effective, though, these treatments require a higher drug concentration within each dose. Researchers already use various testing methods to evaluate drug product stability, from differential scanning calorimetry (DSC) to dynamic light scattering (DLS). While both these methods provide accuracy in the lab using diluted samples, they can’t quickly or effectively measure the stability of real-world concentration levels. Even slight adjustments to the solution environment, including increasing concentration, can introduce unknown and unpredictable changes in high-concentration biologics. Until now, though, analyzing the thermal stability of drugs under high concentration conditions has been time-consuming and challenging.

TA Instruments’ newest innovation, the RS-DSC (Rapid Screening-Differential Scanning Calorimeter), fills a critical testing gap, allowing labs to quickly understand thermal stability of their formulation strength drug products. In this blog, we explore the importance of thermal stability testing and how the RS-DSC drastically improves the process.

Until recently, most biologics have been administered through intravenous injection. For patients, that meant a trip to the doctor’s office and oversight from a professional to receive their life-saving therapies. A simple shot into the skin via needle and syringe is far cheaper and more convenient, which explains the wide adoption of subcutaneous (the innermost layer of skin tissue) injections. From 2017 to 2021, roughly half of all FDA-approved treatments were developed to be administered subcutaneously.

While the method has lowered costs and expanded global access to essential drugs, it makes research and development more complex. Unlike the steady drip of an IV, a shot through the skin requires far less volume, meaning the concentration of the biologic must be significantly higher. That ratio can change the biopharmaceutical stability — and effects the entire development pipeline.

Understanding how a biopharmaceutical responds to thermal stress is an important predictor of shelf-life and efficacy. Short-term thermal stability lends insight into biopharmaceutical structure and understanding how functional variations arise. It is a key metric employed in candidate selection and provides critical information in selecting buffer composition in the development of clinical formulations. Lower thermal stability can be an indicator of aggregation, poor shelf-life, and ultimately drug efficacy. Thermal stability testing ensures researchers know the way a drug will change under stress, letting them predict how that drug will behave in a patient’s home or on a pharmacy shelf.

Aggregation and structural stability are commonly evaluated using light scattering and calorimetry:

Dynamic Light Scattering (DLS): In this method, a laser is passed through a liquid sample, causing light to scatter between individual particles. This lets researchers determine the size distribution and aggregation of drug particles over time. Understanding these changes can help determine if a drug remains safe and effective in varying concentrations and while stored in differing temperatures.

Differential Scanning Calorimetry (DSC): This method uses the controlled application of heat to examine how and when the substance transforms. Researchers can then precisely understand the formula’s stability at different concentrations and under different conditions. Evaluating the thermal stability of a given solution gives insight into the folding and function of the protein and informs understanding of the impact of the solution environment on the protein structure as a whole.

In biologics development, DSC is the gold standard for short-term stability testing. But the process has one major flaw: high-concentration samples must be diluted. That’s because DSC requires a fixed sample cell that must be cleaned between samples. High-concentration solutions can clog the cell when heated, either making it useless or forcing researchers to employ harsh, lengthy cleaning protocols between trials. For intravenous treatments, this isn’t an issue. The low concentration means most tests never reach the instrument’s upper limit. Not so with subcutaneous injections. As the treatment delivery option becomes increasingly popular, the industry needs a scalable, cost-effective, and fast solution that outputs reproducible and accurate results.

The RS-DSC is revolutionary because it can rapidly test a high number of samples at high concentrations and low volume– while still employing calorimetry to provide the most accurate thermodynamic data possible. The key innovation comes from disposable microfluidic chips rather than relying on a fixed measurement cell as seen in traditional DSC instruments. This offers three key benefits:

1. The instrument can test 24 samples simultaneously, significantly increasing throughput while reducing sample consumption.
2. The low volume microfluidic cells only require 11 µL of sample, maximizing material use and minimizing cost.
3. Disposable chips eliminate cleaning and remove the need for dilution. Thus, the effects of formulation strength antibody treatments can be predicted far more quickly and accurately.

All this means the RS-DSC doesn’t only test higher-concentration samples with greater accuracy. It saves time and material, and therefore money. That means breakthrough therapies can reach more patients–faster and cheaper.

Advances in therapeutic biologics mean more and more people will receive life-saving treatment via a shot through their skin. But this convenient, cheap, and easily administered treatment option is only possible if pharmaceutical researchers are completely confident their high-concentration drugs can tolerate real-world conditions. That’s why, in a drug’s journey from lab development to blockbuster adoption, the RS-DSC is now a critical link to better treatments and healthier patients.

The method of drug delivery significantly influences the final stages of the manufacturing process. Currently, lyophilization—a widely adopted technique—enables drug developers to stabilize formulations and therapeutic molecules using a validated commercial approach. In this process, precise control of pressure and temperature within a lyophilizer facilitates the removal of liquids from formulations containing thermally sensitive or hydrolytically unstable active pharmaceutical ingredients or formulation components.¹ The resulting solid product exhibits enhanced stability, an extended storage life, suitability for higher-temperature storage, and ease of packaging compared to aqueous solutions. Remarkably, over 60% of biologics available in today’s market owe their existence to lyophilization, rendering this technique exceptionally attractive for integration into the manufacturing process.

Currently, many lyophilization strategies can be used to develop high-concentration monoclonal antibodies. To begin, the development of successful antibody therapies requires administration at high dose levels. However, it is challenging for high-concentration monoclonal antibodies to be delivered effectively due to their limited intrinsic stability. By introducing an optimal lyophilization process, developers would be able to increase stability, limit storage requirements, and ease the shipping issues. There are three distinct stages in the lyophilization process: freezing, primary drying, and secondary drying. The first stage, freezing, is carried out at temperatures below Tg (glass transition temperature) for an amorphous, or below Teu (eutectic temperature) for a crystalline state, for a sufficient period to allow for full transformation into a solid.² To achieve high crystallization rate and complete crystallization, the annealing temperature is usually held between the Tg of the amorphous phase and the Teu of the bulking agent.² Additionally, it is important to start off by using a moderate cooling point to prevent any degradation.

The subsequent phase, known as primary drying, eliminates frozen water by raising the shelf temperature and reducing chamber pressure. Optimizing primary drying can significantly reduce cycle time and depends on factors such as formulation, shelf temperature, container type, and chamber pressure.2 Overall, achieving a high sublimation rate with uniform heat transfer is the goal during this step. Following primary drying, we encounter the secondary drying phase. Here, water is extracted from the solute phase through desorption. The effectiveness of secondary drying hinges on the ramp rate, which varies based on the product type (whether amorphous or crystalline).² Additionally, various stability-affecting factors—such as antibody concentration, excipients, and container properties—should prompt a case-by-case approach to secondary drying for optimal efficiency. A comprehensive grasp of these three pivotal stages contributes to successful lyophilized product development and streamlines the manufacturing process in drug development.

While lyophilization offers advantages such as increased stability, solid-state drug delivery, and other benefits, it remains a highly specific process demanding meticulous control. Deviations from proper procedures can result in inadequate freezing, equipment overload, or sample damage, ultimately compromising drug efficacy and potency.³ Therefore, comprehensive characterization is essential to optimize sample preparation, lyophilization, and product delivery. Researchers must conduct thermal analysis throughout the entire process to assess how temperature variations impact material properties.

The Tg is the point at which there is increased mobility of a lyophilized sample as it transitions from its frozen, brittle state to a more viscous state.³ It is critical for researchers to identify the glass transition temperature to optimize the temperatures used at each step of the lyophilization process. TA Instruments offers, the Discovery DSC and the Multi-Sample X3 DSC to measure Tg directly. Both instruments utilize TA Instruments’ patented Fusion Cell design to provide the highest level of performance for the most accurate and robust thermal analysis measurements.³ The Multi-Sample X3 DSC offers a distinctive advantage: the capability to simultaneously run three samples, providing a wealth of data in a shorter timeframe.

After freeze drying a sample, researchers can use Thermogravimetric Analyzers (TGAs) to reliably detect even the smallest amount of residual moisture. This analysis can be used to evaluate the quality of the lyophilization process, predict how stable a product is likely to remain, and determine optimal parameters for lyophilization.⁴ In addition, TGA can also measure weight loss due to thermal decomposition, which can reveal insights into how the properties of the product might have changed during lyophilization. TA Instruments offers a range of TGAs for every lab’s needs. The TGA 55 is a rugged, reliable, and cost-effective option with proprietary Tru-Mass balance for the most accurate measurements across competitive models. The TGA 550 offers enhanced performance and flexibility with add-on features and optional expansion. Lastly, the TGA 5500 provides ultimate performance with less drift than any competitive TGA, plus the fastest heating and cooling rates available. Therefore, for any lab attempting to optimize their lyophilization process, TA Instruments offers a TGA to suit their needs.

Finally, it is important to make sure the in-solution properties of the protein have remained unchanged after lyophilization and reconstitution. The Nano DSC allows one to evaluate any alterations in the product’s stability or efficacy by measuring shifts in melting temperature and enthalpy. Using these parameters, the Nano DSC provides insights into whether the lyophilization process impacted molecular stability.

In the world of biologics, stability is crucial. Lyophilization, our trusted ally, preserves delicate formulations and therapeutic molecules. Yet, success hinges on precise temperature control. In this blog, we’ve highlighted the pivotal role of thermal analysis &ndash a compass guiding us toward optimal lyophilization conditions. By using this tool, we optimize the process and protect protein integrity during lyophilization.

在整个 18 世纪，许多科学家都在质疑热的本质。Isaac Newton 认为，热量通过粒子的振动进行传递，而 Robert Hooke 则认为，热量是物体的一种属性，由其各部分的运动产生。1 不过，在热测量历史中，广为人知的首位贡献者是苏格兰医生兼化学家 Joseph Black。1 1761 年，他通过精确测量发现，对处于熔点的冰或处于沸点的水加热不会导致温度变化。1 他的观察使他成为第一个区分温度和热量的科学家，标志着热力学的开端。

继 Joseph Black 之后，许多重要的科学家为量热法和微量热法的发现做出了贡献。Antoine Lavoisier 于 1789 年建造了第一台量热仪，并利用收集到的数据确定，呼吸过程是一种燃烧反应。1 但是，James Prescott Joule 被认为是首位精确测量热量的人。1841 年，他确定了热量的机械当量，即每卡路里做功 4.184 焦耳，可使 1 磅水的温度升高 1 华氏度。1 Joule 的研究证明，热是一种可测量的能量形式。总之，这些重要的里程碑引领我们发展了现代量热法和微量热法。

对现代量热法的首个重大贡献是 20 世纪 20 年代末的用于测量合金混合热的 Kawakami 量热仪。1 近十年后，第一台绝热反应量热仪问世，用于测量金属互化物的直接合成过程。 1 随着技术的进步，测量纳米级反应的能力也得以发展，并被称为微量热法。

微量热法对于评估和推导与物体的状态变化（如由化学反应或物理变化引起）相关的热传递至关重要。近年来，该技术在分子相互作用的生物物理表征中变得尤为有用，以帮助了解结构与功能之间的关系。这些测量的特性包括：

• 焓
• 平衡常数
• 熵
• 吉布斯自由能
• 结合化学计量学

与结构信息相结合，微量热法提供了合理药物设计所必需的大量关键信息。

目前，等温滴定量热仪 (ITC) 和纳米差示扫描量热仪 (DSC) 等高灵敏度微量热仪是最受欢迎的应用仪器。ITC 已成为测量反应过程中释放或消耗热量的主要工具，其受欢迎的原因在于该仪器能够直接快速地确定所有热力学参数，而无需化学标记或固定。2 这使得 ITC 成为一个出色的溶液内检测方法，可用于各种应用中的浑浊、有色溶液或特定悬浮液。2

Nano DSC 被认为是热分析（包括分析材料的热性质和生物分子的熔化温度）中最重要的方法之一。³ 收集的数据非常有助于药物的设计和开发。

这些量热仪易用并配有不同的数据分析软件，可进行更精确的有助于整体分析的测量。

在药物研发过程中，了解药物如何与靶点相互作用至关重要。其特征是，在进入预配方研发的后期阶段使用 ITC 充分了解相互作用背后的驱动力，之后再实施进一步的研发。在大多数情况下，研发目标是获得可与其靶标特异性结合的药物。这将有助于减少任何不必要的副作用。

可根据所表征的相互作用热力学曲线确定结合特异性。结合自由能 (ΔG) 由焓 (ΔH) 和熵 (ΔS) 两部分组成。由熵贡献驱动的相互作用更具特异性，原因是该热量来自 Van der Waals 相互作用和在结合口袋中形成的氢键，不同于作为熵贡献一部分的由疏水相互作用所驱动的相互作用。ITC 还可用于研究酶动力学，而无需任何染料或固定。

酶是一类特殊的治疗药物，因为它们不仅与靶点结合，而且还将靶点转化为产物。在酶学实验中，ITC 可用于监测酶在此过程中产生的热量。通过分析，我们可确定 Vmax（最大催化速率）和 Km（达到半最大速率所需的底物浓度）。研发中可利用这些数值来生产具有更高效力和特异性的酶。

在研发进程中筛选出一批候选产品并准备进行深入研究时，了解分子的构象稳定性和高阶结构非常重要。这将作为分子在不同研发阶段的基准。测量该基准的标准方法是通过 Nano DSC 确定其 T_M（或熔化温度）。生物分子的 T_M 取决于配方缓冲液。通常的做法是测试不同的 pH、盐浓度、赋形剂和表面活性剂，在筛查中查看分子在特定条件下处于稳定还是不稳定状态。然后对配方进行修改，直到达到所需 T_M 的同时可将凝聚降至最低。此外，在生产过程中对高阶结构进行监控同样至关重要，以最大限度降低批次间差异并确保生产出所需的产品。

总之，微量热法在促进对材料和生物过程的理解方面有着悠久的创新历史。如今，在生物药物研发中使用的微量热法工具和技术让研究人员能够检测和开发挽救生命的药物。ITC 和 Nano DSC 是有助于了解生物分子如何与其暴露的环境相互作用的两种测量方法，可在药物研发周期中提供关键见解。

技术的发展日新月异。无论您是升级旧设备还是为您的工作台添加新技术，使用尖端仪器都一定会提高您实验室的效率和成果。新型仪器可提供更可靠的数据和更先进的功能，这对于始终立足于材料创新前沿而言至关重要。

但是，如何在升级仪器以获得最佳投资回报的同时最大限度地减少停机时间呢？以下是可让您无缝且轻松地升级实验室的 4 种方法。

用最新型号的仪器更换服务多年的老旧仪器是改善实验室结果的最简单的方法之一。更好的消息是，您可以用旧仪器换取升级折扣。

2000 年推出的 TA Instruments Q 系列热分析仪彻底革新了测量方法，Discovery 系列以其改进的测量和易用性延续了品牌传统。用户可对其 Q 系列 DSC、TGA、DMA、SDT、TMA 仪器或竞争型号仪器进行以旧换新，以节省购买新的 Discovery 系列热分析仪的费用。Discovery 系列提供无与伦比的灵敏度和准确性，可检测样品中的最小变化，并通过强大的 TRIOS 软件提供革命性的用户体验。点击此处以解更多信息并联系我们以对您的热分析仪进行以旧换新。

同样，您可以对 TA Instruments AR 流变仪或竞争型号仪器进行以旧换新，以节省购买新的 Discovery 混合流变仪的费用。升级到 DHR 实现了卓越的功能改进 – 由于 DHR 优异的扭矩灵敏度，用户可使用更少的样品测量更低的黏度和更小的应力。该仪器的混合功能是游戏规则的改变者：可在一台含集成线性 DMA 的流变仪上进行剪切流变学、黏性/剥离、拉伸黏度测量，以及张力、弯曲和压缩测量。DHR 广泛的功能和配件（包括与许多 AR 配件的兼容性）可为您实验室未来可能需要的任何测量提供保障。联系我们以了解有关流变仪以旧换新的更多信息。

除节省成本外，对您的热分析仪或流变仪进行以旧换新也非常易于操作且回报丰厚：

• 通过承接已有的历史数据和操作程序实现平稳过渡
• 使用新的“无人值守”自动进样器减少瓶颈（可在特定的热分析仪型号上使用）
• 借助专为每个用户级别的易用性而构建的 TRIOS 软件，最大限度地减少操作适应时间
• 通过可靠的结果和更高的准确性提高数据可信度
• 通过新功能和测量选项扩展实验室能力

抗体的稳定性对于抗体药物的性能至关重要。抗体具有较高的热稳定性对于制造具有合理保质期的产品以及避免抗体生物物理特性恶化的问题至关重要。¹
许多抗体，尤其是单克隆抗体，生产成本非常高。²许多合成程序在完成纯化后可能仅产生几毫克产品，这意味着需要使用最少量的样品进行表征和质量控制检查。拉曼光谱等非破坏性方法可能适用于某些类型的测量，但该检测并不总是适合评估抗体稳定性。另一种替代方法是差示扫描量热仪 (Nano DSC)，这是以最少量的样品来检测抗体稳定性的最佳方法之一。

纳米差示扫描量热仪的工作原理是测量与抗体展开或变性事件相关的温度变化。对纳米 DSC 热谱图的解读不仅可提供有关蛋白质是否保持稳定的信息，而且还可从信号标志和峰形状的分析中得出有关变性类型的信息。

TA Instruments 纳米 DSC是一种超灵敏的纳米差示扫描量热仪，用于可靠地测量抗体和其他大分子的稳定性。纳米 DSC 采用易于使用的设计，测量所需的样本低至 2 µg，是常规和研究应用中检测抗体稳定性的理想的纳米差示扫描量热仪。

纳米 DSC 是一种差示扫描量热仪，测量稀释溶液中的生物分子在加热或冷却时吸收或释放的热量。虽然差示扫描量热仪广泛用于制药、电子产品、复合材料等诸多领域，但纳米 DSC 是用于测量生物分子热变化的专门仪器。

TA Instruments 纳米 DSC是行业领先、可高度定制的纳米差示扫描量热仪。这种纳米差示扫描量热仪可通过对极少量样品进行温度斜坡分析，以极高的灵敏度测量抗体稳定性。通过测量反应热损失或增益，热谱图可识别蛋白质稳定性的任何弱点，并用于样品的表征。

包括抗体在内的许多生物分子具有很强的结构-功能关系。不需要的展开可扰乱抗体不同区域间的分子间相互作用，是可能导致所需生物物理特性退化的事件之一。¹ 使用纳米差示扫描量热仪进行此类测量还可提供总体结构信息以及研究结合事件，特别适用于蛋白质-配体相互作用的研究。

由于新治疗性抗体的稳定性通常是研究过程中需要考虑的设计参数之一，因此在抗体的研发阶段测量抗体稳定性非常重要。³

研究人员出于多种原因选择纳米 DSC。与其他竞争设计相比，纳米 DSC 可让您以更少的样品消耗获得更高质量的数据。独特的毛细管铂样品池设计具有 300 µL 的体积，可轻松上样，且具有极高的重现性和灵敏度。

纳米 DSC 可让您灵活设计测试，且仪器提供多种附件，可全方位满足您的应用和实验室需求。其中的一个选项是自动进样器，该进样器最多可与两个 96 孔板兼容，可将您的纳米差示扫描量热仪变成一台“启动即可离开”的机器。纳米 DSC 仪器操作软件提供涵盖缓冲液和溶剂溶液出口的洗涤序列编程选项。

纳米 DSC自动取样器可提高您的生产力和检测量。数据可直接导入 NanoAnalyze 软件进行模型拟合和多批次文件处理，以加速提取用于抗体稳定性分析的重要参数。

请立即联系 TA Instruments，以获取有关纳米差示扫描量热仪如何简化抗体稳定性分析的专家见解。