OPUS® 2.5 - 80R Pre-packed Chromatography Columns
Discover the OPUS pre-packed chromatography column portfolio, which delivers a comprehensive range of ready-to-use solutions designed to streamline purification processes. Pre-packed columns enable scientists and operators to reduce set up time, ensure consistency and enhance overall process productivity and facility efficiency for biopharmaceutical workflows.
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OPUS® 2.5 - 80R cm diameter 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 by eliminating the need for column packing equipment, space and headcounts so scientists and operators can focus on chromatography runs and accelerate 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
- Customize plate count, asymmetry and test method
- Unpack resin using recovery port featured on OPUS® 36R, 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
ULTIMATE FLEXIBILITY
Largest scale, broadest range
To help scientists easily scale from process development to commercial manufacturing volumes, Repligen offers an extensive assortment of pre-packed chromatography columns which are easily configured to the specifications required by your process. Simply select the resin and bed height, and we will pack, qualify and ship the column to your facility quickly. Additionally, OPUS 36R cm, 45R cm, 60R cm, and 80R cm columns are the first pre-packed chromatography columns designed to meet the 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
- ISO 文件 (CoA、RSF)
- 可选择填料 > 250 种
- 每根层析柱进行出厂检测
Ultimate Flexibility
Packed with user-specified resins
Repligen packs over 250 commercially available and custom chromatography resins. Typical resins are 30 to 120 um particle size on base bead matrices composed of agarose, methacrylate, cellulose or polystyrene.
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. The resin recovery port allows operators to clean and re-use the resin in the OPUS column or a traditional self-packed column.
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。
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。
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
HIGH PERFORMANCE
Impact on process economics
Using pre-packed chromatography columns for clinical and commercial manufacturing processes yields significant cost and labor savings.
- 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
- Operational excellence
- Reduced labor requirements
In this example, over 65% cost savings and up to 80% labor savings were achieved when using OPUS Columns compared to self-packed columns.*
*Purchase of OPUS 60R pre-packed column compared to the purchase or a new, 60cm Diameter column and automated self-packing equipment. Data presented is estimated and subject to change.
Click on the + to explore different design features of the OPUS 80R cm column with resin recovery port.
Gamma Irradiation for OPUS 2.5 - 30 cm pre-packed columns
Ensure final product purity and safety using gamma irradiated OPUS columns to reduce bio burden risk. Gamma irradiated columns comply with regulatory standards for product quality and safety and maintain consistent OPUS performance.
- Ideal for large biomolecules where sterile filtration is not an option including: viral vectors, gen therapies and cell therapies
- Risk mitigation to ensure product quality and patient safety
- Plug-and-play solution for continuous downstream processing
- sterility assurance to eliminate bioburden contamination risk
- Facilitated GMP to align to industry best practices
Used resin packing and repacking service
Repligen now offers used resin packing and repacking services. We will repack cleaned and sanitized used resin from used OPUS columns or other pre-packed or self packed columns. Upon receipt of the cleaned and sanitized resin, we will quarantine the resin and column while on site and pack the resin into new OPUS column hard ware or into used OPUS columns (including replacement of ports or other OPUS parts), qualify the column, and return it to our customer. Contact us to learn more about our used resin packing and repacking service.
层析“再设计”
Optimize your chromatography workflow with innovative solutions designed to improve product recovery and purity while enhancing operational efficiency. KRM™ chromatography systems, ProConnex® single-use flow paths, AVIPure affinity resins and C-Tech in-line process analytics technology combined with OPUS® pre-packed columns are solutions designed to work together to improve your downstream process productivity.
Click on the image highlights to see key elements of chromatography redesigned.
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.
2020-12-14
01:34
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.
2021-07-22
03:12
Statistical Process Control Analysis
Utilizing statistical process-control analysis (SPA) offers customers valuable insights into process controls and their impact on column performance. This analysis illustrates how variables such as column size, bed height, and diameter affect the process. Years of data from packing columns with hundreds of different resins have been integrated into process-control charting methods and software that leverage data variance and standard deviations to determine control scores. These scores help users to identify which resin types perform optimally under specific conditions.
We continuously evaluate and optimize packing methods through a plan–do–act–check–repeat cycle. For example, we have detailed data from an ion-exchange resin family, showcasing different column diameters and bed heights. Data from a thousand individually packed columns showed efficiency expressed as reduced height equivalent to a theoretical plate (HETP). Over 95% of the data fell within the standard deviation, providing more than 95% confidence in achieving reduced HETP and well-packed columns. Asymmetry trends were similar, with over 97% of results falling within two standard deviations, ensuring consistently packed columns that perform reliably.
Our commitment to quality and precision in column packing is evident through these comprehensive analyses and results.
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