Merck

Stay Ahead

As a leading partner and supplier to the biopharmaceutical industry, we continue to strengthen our supply chain to help you stay ahead.


Chromatography Supply Program

Chromatography resins are often sourced from a single supplier, as the qualification process is lengthy and costly. 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 supply process that incorporates six key attributes.

  • Raw material selection and characterization
  • Integration of base beads production
  • Multiple manufacturing sites and a global quality standard
  • Product and process characterization
  • Robust change control process
  • Transparency of information and Emprove® dossier

We can help you stay ahead by providing the resin quality and quantity you need – when you need it.


Raw material selection and characterization

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

Integration of base beads production

We manufacture base beads at our own state-of-the-art dedicated production facility for Eshmuno® and ProSep® resins. In addition, we have strong supply and quality agreements with a set of trusted suppliers for Fractogel® base beads and other critical raw materials. We can meet the increased demand for resins as the need arises while ensuring lot-to-lot consistency and enabling robust change control.

Multiple manufacturing sites and a global quality standard

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, applying industrial/ISO standards and our own standard global quality manual. Each site also has a business continuity plan which may leverage strategies such as increasing safety stock of raw materials, qualifying second sources, and increasing capacity to secure supply of chromatography resins to our customers. Disaster recovery plans are also in place at each site, documenting potential risks and identifying actions to take in order to expedite recovery.

Product and process characterization to ensure 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. We have implemented a robust process characterization and control methodology to ensure lot-to-lot consistency, utilizing our extensive process knowledge and production experience.

Transparency of information and Emprove® dossier

We have expanded our Emprove® program to include chromatography resins, helping you meet the latest regulatory requirements for risk assessments and speed your way through the regulatory maze. Emprove® Chromatography addresses these specific needs during selection and qualification of our chromatography resins.

Robust change control process

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


Infographics

Our Overall Approach to Change Control

Infographic: Our Overall Approach to Change Control

Our Process Characterization and Control Methodology

Infographic: Our Process Characterization and Control Methodology