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Supply Program

Supply Robustness and Control.
Stay ahead.

Chromatography resins are often sourced from a single supplier as the qualification process is lengthy and costly. As a result, security of supply is of high importance to our customers and to us. To improve on-time delivery reliability, and product quality of our chromatography resins, we have implemented a robust process that incorporates:

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Raw Material Selection
& Characterization		 Integration of Base
Beads Production		 Multiple Manufacturing Sites & Global
Quality Standard		 Product & Process Characterization Robust Change
Control Process		 Transparency of
Information &
Emprove® Dossier
Raw Material Selection and Characterization
Harmonized Quality Control and Supplier Management

When selecting reliable raw materials for our beads and surface modifications, we make sure they will be available in the same quality and quantity as you scale up your process. We do this through:
  • Detailed material characterization during process development
  • Harmonization of our raw material quality control and supplier management across our chromatography resins manufacturing plants.

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Eshmuno CP-FT ResinBase beads are critical components of chromatography manufacturing.
Integration of Base Beads Production
Controlling Delivery and Quality of Critical Materials

We manufacture base beads at our own state-of-the-art dedicated production facility for Eshmuno® resins and have established strong supply and quality agreements with a set of trusted suppliers for Fractogel® base beads and other critical raw materials. With both, we are able to successfully meet increased demand for resins as the need arises, ensure lot-to-lot consistency and enable consistent change control. 



Multiple Manufacturing Sites and Global Quality Standard
Ensuring Highest Quality Grades Across All Sites

Our manufacturing plants are suitable for multiple resin production, thanks to comparable equipment, know-how, and our global Bioprocess Resin (BPR) quality system. The BPR Quality Marker program ensures one global quality standard for chromatography resins across all sites, through application of industrial/ ISO standards and implementation of a standard global quality manual.

Furthermore, each site has a business continuity plan, which may leverage several strategies, such as increasing safety stock of raw materials, qualifying 2nd sources, and increasing capacity to secure supply of chromatography resins to our customers. Each site also has a disaster recovery plan that documents potential risks and identifies actions to proactively implement in order to expedite recovery. 

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Product and Process characterization
Ensuring Lot-to-Lot Consistency

Lack of consistency in raw materials and operations can create significant variation in the performance of chromatography resins, causing unexpected variability in your process. To address this, we have leveraged our extensive process knowledge and production experience to implement a robust process characterization and control methodology lot-to-lot consistency.

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A Robust Change Control Process
Minimizing Impact of Changes

Our goal is to secure supply, enable lot-to-lot consistency and minimize the impact of change. We provide you with the comprehensive information you need, in the form of comparability studies, to assess and accept the changes prior to implementation. In the event that you need to perform additional testing, post-change samples from different lots are available.

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Emprove® program
Your fast track through regulatory challenges now available for chromatography!

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We are expanding our Emprove® program to chromatography resins to help you meet the latest regulatory requirements for risk assessments and speed your way through the regulatory maze.

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