技术专栏
本专栏是介绍有关生物医学下游色谱工艺的专栏。介绍诸如单克隆抗体、疫苗、基因、病毒载体等的纯化技术。 您将能够使用这些技术来构想Cellufine产品的下游工艺构成。
用Cellufine产品从CHO培养上清液中纯化单克隆抗体
用三步层析从CHO细胞培养上清液中纯化单克隆抗体。 实验中使用了Cellufine SPA-HC，Cellufine MAX Q-h和Cellufine MAX GS。
使用纤维素系色谱载体（Cellufine）的高效单克隆抗体精制方法
在单克隆抗体（mAb）生产工艺的下游（精制工艺），蛋白质A柱的捕获工艺以及被称为纯化（Polishing）的去除杂质工艺，通常采用色谱分离方法。此次我们介绍的是把在该纯化工艺中所使用的2个层析柱连接，并进一步在流穿模式下使用的方法（FT-FT模式）。
使用Cellufine亲和载体及混合模式载体的单克隆抗体纯化的两步法纯化
本报告中报告了通过Protein A色谱实施的捕获工序与通过Cellufine MAX IB实施精制（polishing）工序的两步法纯化，实现单克隆抗体的高纯度纯化的方法。通过实现两步法纯化，能够减少下游工序的纯化设备投资，并实现降低运营成本。
使用 Cellufine Sulfate 的人冠状病毒 OC43 的 纯 化事例
本报告将介绍通过病毒纯化经验丰富的Cellufine Sulfate实施的hCoV OC43的纯化示例。β冠状病毒hCoV OC43是通过Cellufine Sulfate进行高纯度纯化后的病毒。Cellufine Sulfate是对β属冠状病毒纯化有效的色谱载体。
用Cellufine Phosphate精制T7RNA聚合酶
近年来，mRNA疫苗作为一种非常有名的新冠（COVID-19）疫苗，在mRNA疫苗的生产工序中，就会用到T7 RNA聚合酶。 本文介绍的例子就是在大肠杆菌（pAR1219）中表达RNA聚合酶之后，再利用Cellufine Phosphate和Cellufine MAX DEAE(弱阴离子交换介质)精制其高纯度发酵液。 利用Cellufine Phosphate这种亲和层析介质能够精制纯度极高的酶。
通过CellufineTM对Streptococcus pneumoniae血清型19F的莢膜多糖类的纯化
肺炎链球菌是肺炎的主要病原体之一，在全世界尤其是儿童和老年人会引发高患病率和高死亡率。 最重要的毒性因子之一是细菌表面的莢膜多糖(CPS) ，基于该莢膜多糖的肺炎球菌疫苗被用于预防这些传染病。 以往的乙醇沉淀采用以纯化适合绝大多数血清型的CPS为目的的常规流程。但是，这些工艺复杂且用时较长。 这里将提出无需采用乙醇沉淀的简易化2步CPS层析纯化流程提案。这种流程采用了疏水相互作用层析 (HIC)及阴离子交换层析 (AEX)。 本文将介绍实现这种流程最优化的2种层析介质Cellufine MAX Butyl HS和Cellufine MAX Q-hv。
简单易懂的抗体药物制造方法讲解
抗体药物因针对特定病原体和疾病具有较高的特异性和有效性，近年来受到医学界的广泛关注。然而，制造过程极其复杂，需要先进的技术。本次我们将深入浅出地讲解抗体药物的制造工序。
Separation of complete and empty AAV particles using AEX chromatography media based on cellulose-based MLP
To address the challenge of removing empty particles (i.e., DNA-unencapsulated particles) in AAV production, we developed and evaluated an AEX chromatography resin based on cellulose-derived monolithic particles (MLP) with continuous pores. By controlling particle size and pore size, we achieved improved dynamic binding capacity and resolution compared to conventional AEX chromatography resins. A 50 L culture-derived raw material was subjected to polishing purification using this resin after AFF purification, achieving high purity of 91.1% in one purification run and 97.4% in two purification runs. This resin is effective as a scalable empty particle removal technology that can replace gradient ultracentrifugation and contribute to the production of high-purity (approximately 95% full) and high-yield AAV formulations. *This document was presented at BioProcess International 2024, Boston.
Development of a Cellulose Monolith-like Particle for Sulfate Pseudo-affinity Chromatography Targeting Vaccine Purification
We developed and evaluated a chromatography resin based on cellulose-derived monolithic particles (MLP) with continuous pores for the purification of large biopolymers, particularly virus particles used in vaccines. MLP 1000 DexS, modified with dextran sulfate, exhibited high dynamic binding capacity and recovery through affinity, achieving greater adsorption and impurity removal for influenza A (H1N1) than conventional chromatography resins. Its high strength and low pressure drop make it useful for scale-up, contributing to the efficiency of downstream processes in vaccine manufacturing. *This document was presented at BioProcess International 2024, Boston.
Reducing Host Cell Proteins (HCPs) During Monoclonal Antibody Purification Using Multimodal Chromatography (MMC) resin
We developed and evaluated a novel multimodal chromatography (MMC) resin effective for polishing purification after Protein A chromatography. This chromatography resin uses continuous-pore cellulose-derived monolithic particles (MLPs) as a support, with long-chain alkyl groups modified with primary amines. Optimizing the pore size enables powerful reduction of host-derived proteins (HCPs) even at high loads. Using the resin in flow-through mode, we achieved approximately 99% recovery of monoclonal antibodies (mAbs) and reduced HCPs to a minimum of 8 ppm. Because the effect of residence time is minimal, high flow-rate purification contributes to shorter processing times. *This document was presented at BioProcess International 2024, Boston.
Development of cellulose-derived monolithic particles (MLPs) with continuous pores as a next-generation modality for virus particle purification
We have developed cellulose-based monolithic particles (MLP) with continuous pores specifically designed for the purification of large molecules, such as virus particles used in vaccines and gene therapy drug substances. The porous structure with straight pores (mode radius approximately 1.5 µm) allows easy access to the particle interior, achieving high dynamic binding capacity. MLP 1000 DexS, modified with dextran sulfate, demonstrated high recovery and highly purified removal of contaminants in the purification of influenza A and SARS-CoV-2. Furthermore, AEX-modified resins have been shown to outperform existing products in the separation of AAV empty and filled capsids. We will continue to develop these new chromatographic resins as highly effective for next-generation modalities. *This document was presented at BioProcess International 2025, Boston.
The newly developed Cellufine™ Phosphate HC enables efficient purification of T7 RNA polymerase and other large biomolecules.
Cellufine™ Phosphate HC is a novel, high-adsorption chromatography resin with expanded pore volume. It features a unique ligand consisting of phosphate groups modified on cellulose particles. It is suitable for purifying large nucleic acid-binding proteins (over 30 kDa) and can be efficiently purified without the need for a His tag. For T7 RNA polymerase, the dynamic binding capacity is approximately nine times higher than that of existing products. Purification from E. coli lysate consisted of the following steps: 1) reduction of DNA and impurities with Cellufine™ MAX DEAE, 2) affinity purification with Cellufine™ Phosphate HC, and 3) endotoxin reduction with Cellufine™ ET Clean L. These three purification steps rapidly achieved high activity and purity. *This document was presented at BioProcess International 2025, Boston.
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