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.

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.

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, a single source 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.

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, quick-turnaround service for small scale, custom media intended for bioprocess development.

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.

• Range of hard-walled containers
• EZ BioPac^® Powder Transfer Bags with Right Sized Weighing
• Custom packaging as needed

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.

• Temperature-controlled freight
• Temperature monitoring and tracking options
• Just-in-time delivery capable

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