Market Profile: Mixed-mode Chromatography
     
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    Chromatography consists of separation techniques based on molecular differences such as size, charge, polarity, solubility, affinity, etc. In chromatography, there is a mobile phase and a stationary phase within a column. The mobile phase typically consists of a mixed solution containing the target analyte to be isolated and purified or detected. The stationary phase consists of resin, which is designed to separate the molecules by retaining them for different periods of time. Resins, also referred to as separations media, exist in a wide variety of types, volumes and grades. There are many different ways for the stationary phase to retain analytes inside the column, including reverse phase, normal phase, ion exchange, size exclusion chromatography, affinity, etc.

    色谱法由基于分子差异(如大小、电荷、极性、溶解度、亲和力等)的分离技术组成。在色谱法中,色谱柱中存在流动相和固定相。流动相通常由含有待分离和纯化或检测的目标分析物的混合溶液组成。固定相由树脂组成,树脂旨在通过将分子保留不同的时间段来分离分子。树脂也被称为分离介质,其类型、体积和等级多种多样。固定相有许多不同的方法可以将分析物保留在色谱柱内,包括反相、正相、离子交换、尺寸排阻色谱、亲和力等。

    Mixed-mode chromatography involves the usage of more than one separation mode. The most popular combination is reverse phase and ion exchange methods. In reverse phase, a polar mobile phase and a non-polar stationary phase are used for column separations. Meanwhile, ion exchange separations utilize ionic attraction and repulsion between charged species. The combination of these methods allows the separation of both polar and non-polar analytes in a single column.

    混合模式色谱法涉及使用多种分离模式。最受欢迎的组合是反相和离子交换方法。在反相中,极性流动相和非极性固定相用于色谱柱分离。同时,离子交换分离利用带电物种之间的离子吸引和排斥。结合使用这些方法,可以在单个色谱柱中分离极性和非极性分析物。

    The biggest advantage of this method is that users can fine-tune separation selectivity by adjusting several conditions such as mobile phase ionic charge, pH and organic/non-organic solvents. The mixed-mode approach has been evolving from mixed packed beads to single ligands, which yields homogeneous and reproducible results. The zwitterionic ligand is the next generation of mixed-mode separation and includes both anionic and cationic functional groups in each ligand. The mixed-mode technique is commonly used in the pharmaceutical and biotechnology sector to analyze and purify biomolecules. Companies in this end-market mainly drive demand for mixed-mode chromatography resins, but other industries that focus on the production and purification of biomolecules, such as CROs, are involved in the market as well.

    这种方法的最大优势在于,用户可以通过调整流动相离子电荷、pH 和有机/非有机溶剂等多种条件来微调分离选择性。混合模式方法已经从混合填充珠子演变为单一配体,从而产生均匀且可重复的结果。两性离子配体是下一代混合模式分离,每种配体中都包含阴离子和阳离子官能团。混合模式技术通常用于制药和生物技术领域,用于分析和纯化生物分子。该终端市场的公司主要推动了对混合模式色谱树脂的需求,但其他专注于生物分子生产和纯化的行业(例如CRO)也参与了该市场。

    The largest market by application for mixed-mode chromatography is in mAbs analysis and purification. In this application, mixed-mode resins are most commonly used to remove host cell proteins, antibody aggregates and excess proteins. Aside from mAbs, mixed-mode separation is also used to purify recombinant proteins, viruses, enzymes, biosimilars and vaccines.

    混合模式色谱的最大应用市场是单克隆抗体分析和纯化。在这种应用中,混合模式树脂最常用于去除宿主细胞蛋白、抗体聚集体和多余的蛋白质。除单克隆抗体外,混合模式分离还用于纯化重组蛋白、病毒、酶、生物仿制药和疫苗。

    The overall mixed-mode chromatography market, which includes prepacked columns and resins, reached more than $100 million in 2019. Growth in 2020 is projected to be almost flat as the pandemic has significantly diminished general chromatography demand due to lab closures. On the bright side, COVID-19-related research also buoys mixed-mode chromatography demand, particularly for virus and vaccine applications. In the long run, the mixed-mode market will restore its robust growth in 2021 and 2022, driven by pent-up demand and increasing biotherapeutic interest.

    2019年,包括预包装色谱柱和树脂在内的混合模式色谱市场总额超过1亿美元。由于实验室关闭,疫情大大减少了对色谱的需求,预计2020年的增长将几乎持平。好的一面是,与COVID-19相关的研究也刺激了混合模式色谱的需求,特别是对病毒和疫苗应用的需求。从长远来看,在被压抑的需求和日益增长的生物治疗兴趣的推动下,混合模式市场将在2021年和2022年恢复强劲的增长。

    The market has a strong base in North America and Europe, supported by significant demand from advanced research labs and biotech giants established in these regions. However, emerging markets such as China and India will lead regional growth, driven by substantial investment in the biotech and biopharma industries in these countries.

    在北美和欧洲建立的先进研究实验室和生物技术巨头的巨大需求的支持下,该市场在北美和欧洲拥有强大的基础。但是,中国和印度等新兴市场将在这些国家对生物技术和生物制药行业的大量投资的推动下,引领区域增长。

    In terms of vendor share, Cytiva, formerly known as GE Healthcare before Danaher's acquisition (see IBO 2/28/19), is the leading supplier in the market. The company has a diverse portfolio of mixed-mode resins that cover all of the aforementioned applications. Cytiva also has one of the largest total portfolios of resins designed for vaccine development. Meanwhile, MilliporeSigma has a narrower range of resins, which are targeted primarily towards antibodies and proteins. On the column side, Thermo Fisher Scientific and Waters are the leaders in supplying mixed-mode HPLC columns.

    就供应商份额而言,Cytiva是市场上领先的供应商,在丹纳赫被收购之前被称为GE Healthcare(见IBO 2/28/19)。该公司拥有多样化的混合模式树脂产品组合,涵盖了上述所有应用。Cytiva还拥有专为疫苗研发设计的树脂总量最大的产品组合之一。同时,MilliporeSigma的树脂范围较窄,主要针对抗体和蛋白质。在色谱柱方面,Thermo Fisher Scientific 和沃特世是提供混合模式高效液相色谱柱的领导者。

    Leading Vendors

    领先的供应商

    Cytiva (Danaher)

     

    MilliporeSigma

    milliporeSigma

    Bio-Rad Laboratories

    生物拉德实验室

    Largest Markets

    最大的市场

    Biotechnology

    生物技术

    Pharmaceutical

    制药

    CROs

    CRO

    Column Cost

    列成本

    $630–$1,300

    630—1300 美元

    Resin Cost

    树脂成本

    $1,000–$8,500/L

    $1,000—8,500 美元/升