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:
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.
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.
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.
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:
The right quality testing and documentation are essential features of a custom cell culture product. For example, we offer:
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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