Custom GMP Cell Culture Products
For decades, biopharmaceutical companies have trusted us to deliver high-performing cell culture products for a diverse range of biologics, both on market and in development. We understand, conceptualize, and continue to invest in new capabilities and solutions which solve the toughest challenges faced by this industry.
Whether we are designing and manufacturing one of our proprietary platforms or providing support to manufacture your custom formulation, our experts provide the design support you need for products such as:
- Cell culture media, feeds, and supplements in liquid or dry powder form
- Buffer solutions for upstream or downstream applications
- Concentrates for intensified or dilution processes
Our global design team partners with every client to understand and meet their exacting standards. We can show you a wide range of options, including sites of manufacture, raw materials, quality testing, documentation, and final package delivery. Our network of manufacturing facilities allows for global supply with regional support closer to your different sites.
Related Product Resources
Custom Cell Culture Product Design
As you evolve your bioprocess from clinical to commercial scale, our products are scalable and reliable in batch sizes from 50 L to 10,000 L for liquid products, or 25 kg to 6,000 kg for dry powder products.
Liquid Products
- Our process technology features qualified mixing vessels for complete dissolution prior to sterile filtration through an 0.2 μm system, or optional 0.1 μm system.
- Final container choices include standard PET bottles (100 mL–2,000 mL), as well as standard or custom bags (1 L–500 L) with convenient connector options.
- Container protection for shipment includes tamper evident seals for safety.
- HTST pasteurization option is available for glucose solutions.
Dry Powder Products
- Our process technology features pin-milling and conical or tumble blending for homogeneity of final product.
- Packaging container options range from small-scale bottles to larger-scale buckets and barrels.
- Product is closed for safe transport, with tamper evident seals for safety.
- EZBioPac® bulk powder transfer bags and Right Sized Weighing offer the perfect solution for ready-to-use delivery without any weigh manipulations.
- Compacted cell culture media, like the custom EZMix™ product line, delivers equivalent performance to dry powder media and offers important advantages for intensified upstream processes. Compacted media is easy to hydrate, requires less packaging volume, and has enhanced flowability, resulting in significant savings, reduced footprint, and increased upstream flexibility.
Dry small-scale bottles to larger-scale buckets and barrels.
- Prodr bags and Right Sized Weighing offer the perfect solution for ready-to-use delivery without any weig manipulations.
Pre-GMP Cell Culture Media Products
- In addition, our imMEDIAte ADVANTAGE® service provides small scale custom media, feeds, supplements, and buffers with the quick turn-around you need to complete development work, in batch sizes of 1–200 L for liquid products or 0.5–20 kg for dry powder products.
Our products are made in dedicated facilities that meet industry requirements for Animal Component Free (ACF) or Animal Component Containing (ACC) formulations. All facilities and equipment are designed and operated to meet biopharmaceutical standards, regularly receive customer approval, and are confirmed by auditing agencies.
Our Global Quality Management System is certified as ISO 9001:2015, and all sites voluntarily comply with the Joint IPEC-PQG Guide on Good Manufacturing Practices (GMP) for Excipients and applicable sections of Annex 1 of the EU Guidelines to Good Manufacturing Practice for Medicinal Products.
Raw Material Selection and Specification
When you need assistance with raw material selection, we can guide you at every step with expert attention to your key requirements. We leverage our experience with the hundreds of different types of raw materials and raw material characteristics. Our raw material program includes:
- Vendor management – we define and align the right supply chains to ensure security of supply, while ensuring the right raw material quality attributes. We require our suppliers to provide us with change notification, complete site and material questionnaires, allow on-site audits, and provide information regarding their process and other source information as needed.
- Raw material requirements – our experts define each raw material specification to include bioprocess-specific requirements of endotoxin, bioburden, identity, impurities, performance, and, if needed, other unique raw material-specific attributes.
Quality Testing and Documentation
The right quality testing and documentation are essential features of a custom cell culture product. For example, we offer:
- Standard testing – pH, osmolality, appearance, solubility, bioburden (dry powder), or sterility (liquid)
- Optional testing – mycoplasma testing, cell performance testing, analytical analysis for amino acids, vitamins, and much more
- We also know the importance of trace elements and their impact on protein and product quality, so we can add trace element testing to your product specification.
- Safety data sheets and a certificate of analysis are included with every order, in addition to other forms of document support needed for your drug substance filing.
When you are ready to begin, simply complete and submit the reply form below. One of our experts will be in touch soon to guide you through the process.
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