层析“再设计”

Repligen is revolutionizing how modern chromatography is performed. The result? Unprecedented recovery and operational efficiencies even with the most complex modalities.

Click on the image highlights to see key elements of chromatography redesigned.

 ULTIMATE FLEXIBILITY

Largest scale, broadest range

In response to the need to scale up chromatography processes, Repligen offers the largest pre-packed columns for the bioprocess industry. OPUS® 45R,  60R and 80R Columns are the first pre-packed columns designed to meet the chromatography requirements of larger 1000L and 2000L single-use bioreactors.

  • 可针对柱床高度、填料和应用进行简单的配置
  • Seamless scale-up from smaller OPUS® Columns
  • 针对GMP使用的完整文件包
  • 相比传统层析柱技术,显著节省时间和成本
  • 一致的结构材料
  • VI级、EMA 410/01 合规材料
  • GMP 和 pre-GMP 质量文件包
  • ISO 文件 (CoA、RSF)
  • 可选择填料 > 150 种
  • 每根层析柱进行出厂检测
 Ultimate Flexibility

Packed with user-specified resins

Repligen packs > 250 resins from 60 resin families >15 resin vendors. The most frequently packed resins are 30-120μm in particle size and based on matrices of agarose, methacrylate, cellulose, and polystyrene material.  A convenient resin pick-up service is available upon approval.

完整填料列表

 

     

亲和

Repligen CaptivA® 和 CaptivA® HF
Repligen NGL COVID-19 刺突蛋白 AF 基质
Repligen AVIPure® AAV2、AAV8 和 AAV9
Purolite Praesto® AP/AP+, Jetted A50/A50+
Cytiva MabSelect™ 家族
Cytiva AVB Sepharose™ HP
Cytiva Capto™ PlasmidSelect
Thermo POROS® CaptureSelect™ AAV/AF 型
Thermo POROS® Heparin
Tosho TOYOPEARL® AF-rProtein A HC-650F

IEX/混合模式填料

JSR Amsphere™ A3
KANEKA KanCap™ A
不同供应商的 IMAC/螯合/镍
Purolite Praesto® (IEX)
Cytiva Capto™ ImpRes (IEX, HIC, MMC)
Cytiva Capto™ (IEX, HIC, MMC)
Cytiva Capto™ Core 400 和 700
Cytiva Capto™ S ImpAct
Cytiva Sepharose™ FF (IEX, HIC, MMC)
Cytiva Sepharose™ HP (IEX, HIC, MMC)
Cytiva SOURCE 30 (Q 和 S)
Cytiva Superdex (75 和 200)
Cytiva  Sephadex G25

ABT Rapid Run Agarose Bead (IEX)
Thermo POROS® 50 um (IEX, HIC)
Thermo POROS® 20 um (IEX)
Tosoh TOYOPEARL® (IEX, HIC, MMC)
Millipore Fractogel® (IEX)
Millipore Eshmuno® (IEX)
Sartorius HyperCel™ (PPA, HEA, CMM, MEP)
BioRad Nuvia™ (IEX, MMC)
BioRad Nuvia™ HP (IEX)
BioRad UNOsphere™ (IEX)
BioRad CHT™ Types: I & II, 40um, 80um, (≤60cm IDs)

Access CHT™ Resin pre-packed in OPUS Columns

Ceramic hydroxyapatite (CHT™) resin offers unique selectivity during the purification of mAbs and recombinant proteins. OPUS Columns can now be pre-packed with CHT™ resin and shipped world wide with excellent performance.

  • 内径范围: 5 - 45 cm
  • 柱床高度:5 - 30 cm

View the full performance data

CHT™ 为 Bio-Rad Laboratories Inc. 注册商标

运输后仍保持性能

运输后平均塔板数和不对称性变化分别在运输前检测值的8%和3%以内。绝对值在规格范围内。

 Ultimate Flexibility

Innovative resin recovery port

 

从预装到拆装

With an innovative side port that allows for easy resin unpacking, OPUS 45R, 60R, and 80R Columns provide the ultimate flexibility in pre-packed column technology.

Without compromising  chromatographic performance or cleanability, the new feature helps mitigate the risk of implementing pre-packed columns in GMP settings, and allows for re-use of the unpacked resin in other columns.

In the event of a deviation, and if the OPUS pre-packed column performance cannot be recovered, the column can be unpacked and the resin can be repacked into a traditional, self-packed column. 
After the intended usage of the OPUS pre-packed column, the column can be unpacked and resin transferred to a development or pilot setting for additional use.

OPUS® 液流分配器设计可维持均匀的液流分布。该设计采用了行业广为接受的技术,包括径向流场和反向喷射漏斗。 

在OPUS® 层析柱的开发过程中,将分散性作为柱效的影响因素进行了建模,以确定液流分配器的关键参数。通过在OPUS® 应用实验室进行的计算机流体动力学建模和应用案例研究,对最终设计进行了质量确认。  

VIEW POSTER

OPUS® 层析柱由医用级聚丙烯同聚物构成,所有产品接触表面均符合EMA 410/01 (或无动物源性)及VI级要求。

部件结构材料
2.5 - 30 柱管聚丙烯
45 R- 80 R 层析柱管70% w/w E-玻璃 / PP 工程复合结构
液流分配器聚丙烯
进口 / 出口 聚丙烯
柱床支撑筛网 聚丙烯
O型圈 铂金硫化医用级硅胶
回流管 含强力聚酯纤维强化的铂金硫化医用级硅胶

OPUS® 层析柱兼容单克隆抗体、重组蛋白或疫苗典型下游工艺运行中常用的清洗和消毒程序。

使用磷酸盐降低的色度检测显示,装填6 FF的 OPUS® 20层析柱可在仅2 CV内可靠地清除残留的磷酸盐。  

  • OPUS® 层析柱无显著的死腔
  • OPUS® 层析柱设计易于清洗

VIEW TECHNICAL NOTE

   HIGH PERFORMANCE

Impact on process economics

Substantial savings in manufacturing costs and labor are realized because OPUS Columns offer the benefits that come with pre-packed technology:

  • 无前期资本支出
  • 减少CIP程序和交叉污染
  • 更快的运行轮转时间
  • 卓越运营(降低劳动力需求)

In this example, over 65% cost savings and up to 80% labor savings were achieved when using OPUS Columns compared to self-packed columns.*

*Assumptions: OPUS 60R Pre-packed Column versus purchase of new 60 cm diameter automated self-pack equipment (columns are dedicated to a specific molecule). Data presented are estimates and subject to change.

OPUS® 2.5 - 80R Pre-packed GMP-ready Columns

OPUS® Pre-packed Chromatography Columns provide linear scale-up from process validation to commercial and GMP manufacturing. Select from the broadest portfolio of pre-packed GMP-ready column sizes, including large scale OPUS® 45R, 60R, and 80R Columns. Pre-packed columns enhance facility efficiency overall by converting column packing resources into productive chromatography and accelerating campaign turnaround time.

纯化工艺创新

  • 配置柱床高度至毫米精度
  • 可装填几乎来自任意供应商的任意填料
  • 可定制塔板数、不对称性和检测方法
  • Unpack resin using recovery port featured on OPUS® 45R, 60R and 80R columns
  • 在ISO 7 级洁净室内装柱
  • 完整的法规支持文件
  • 提供针对每根层析柱配置的分析证书
     

OPUS GMP manufacturing process 

Click on the links to explore different features.

R 因子视频博客
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The OPUS® time machine

OPUS® Columns pack your choice of resin and the most precious element of all, time, into a self-packed ready-to-use chromatography column at almost any size and for almost every application. Skip months of hardware validation, execute more runs--and still leave work early to enjoy a bike ride. Don’t worry, we won’t tell your boss.

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Small but mighty

Reallocate column packing time and resources toward productive GMP-level chromatography, even at small-scale. The family of OPUS® Pre-packed Columns now includes the small but mighty OPUS® 2.5. Scale GMP purification effortlessly from 2.5 cm to 80 cm ID.

Manufacturing Centers of Excellence

Repligen在ISO 9001质量管理体系下开发和生产用于生物制药行业的产品。我们专注于及时交付高质量、一致且稳健的产品,以确保我们客户的业务连续性。

Repligen manufacturing sites are located in Massachusetts, California, and New Jersey in the United States and in Sweden, France, The Netherlands,  Germany and Estonia.

地点

客户至上。

Repligen DNA 为您提供支持。我们的目标是提供卓越的客户体验,并为所有 Repligen 产品和服务高效成功的采用及实施提供支持。

  • Field Application Support
  • 客户服务
  • 现场服务工程师

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