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CCell Culture Media Supply Program

Lack of consistency in cell culture media can create variation in your upstream process. To control cell culture media variability and ensure the quality of our products worldwide, we have implemented a robust supply process that incorporates three key attributes:

Manufacturing Locations

Our supply chain experts are committed to providing the highest quality in cell culture media, earning your utmost confidence in our consistency anywhere in the world.

Global Raw Materials and Vendor Management Program

We require high standards from our suppliers. We collaborate and manage requirements for their quality systems to include communication of change and visibility into their process when needed. Our raw material experts work with our suppliers to define the right quality attributes for the raw material, ensuring that the right raw materials are in our products. Our procurement experts purchase the same approved cell culture media raw materials, from the same qualified suppliers, for use at all our manufacturing sites.

You can be confident that you are receiving the highest quality and consistency from any of our manufacturing sites around the world.

Characterizing Raw Materials – Understanding Trace Element Variability

To help you better understand your cell culture media, we developed a raw material characterization program to study our raw materials and provide the scientific rationale for intelligent raw material specifications. We also identified those raw materials at risk for trace element impurities and established monitoring programs. And when there is change in our supply chains, we include the risk of trace element impurities in our evaluation of any potential variability.

The role of trace elements and the impact on protein and product quality is well documented. We can offer the right data to begin understanding this variability, with the option of quantitative testing by Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for copper, manganese, zinc, molybdenum, nickel, vanadium, aluminum, selenium, chromium, and cobalt.

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Global Quality Management System and transparency of information

Our cell culture media facilities are covered under a comprehensive company-wide Global Quality Management System featuring:

  • ISO 9001:2015 site certification
  • Standard quality control assays for media using harmonized current compendia methodologies
  • A tiered approach for customer inquiries to provide you with a quick and appropriate support

We are committed to staying at the forefront of all relevant guidelines and regulations.

  • To ease your regulatory efforts for risk assessment and accelerate your progress through regulatory requirements, we are expanding our Emprove® Program to a number of catalog media.
  • Our sites* now voluntarily comply with the Joint IPEC-PQG Guide on Good Manufacturing Practices for Excipients and applicable sections of Annex 1 of the EU Guidelines to Good Manufacturing Practice for Medicinal Products.

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Consistent Manufacturing Network with Harmonized Sites and Redundant Facilities

We know the challenges global biopharma companies can have with securing dual sources of cell culture media. We provide manufacturing redundancies for dry powder media in Europe and the United States, by offering two sister sites-same technology, consistent sourcing of raw materials, and global quality management to deliver dual sourcing from one supplier.

The result? With our global supply network and duplicate production sites that deliver proven product comparability and high quality, there is no need to procure from a second supplier in order to mitigate supply chain risks.

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Clinical to Commercial Manufacturing Capability

We offer dry powder manufacturing volumes in lots ranging from 25 kg to 6,000 kg, as well as the small volume powder and liquid formats typically used for prototyping, troubleshooting, or down-scale modeling. These smaller quantities are provided through our imMEDIAte ADVANTAGE® centers, a quick-turnaround service for small scale, custom media intended for bioprocess development.

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Packaging and Storage Customization

We provide a range of qualified primary and secondary packaging to ensure the protection of our product, as well as tamper evident seals to demonstrate security from our facilities to yours.

With a network of temperature-controlled warehouses all over the world, we have the capability to offer a range of shipping and storage options to meet your needs.

  • Range of hard-walled containers
  • EZ BioPac® Powder Transfer Bags with Right Sized Weighing
  • Custom packaging as needed
  • Temperature-controlled freight
  • Temperature monitoring and tracking options
  • Just-in-time delivery capable

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*Applies to sites in Lenexa and St.Louis USA, Irvine UK, Darmstadt Germany, and Nantong (liquid) China.