Mammalian Cell Culture
One of the major services we provide is recombinant protein drug substance production derived from mammalian cell culture. Our manufacturing team works in close coordination with the tech transfer group to ensure a seamless transition from lab-scale to clinical production. At VxP Biologics, cell culture is scaled-up into our traditional stainless bioreactors or single-use bioreactors to meet your specific requirements and project guidelines. We are experienced with almost all types of culture formats such as traditional plates, flasks, roller bottles, and spinner vessels. Please contact us should you prefer that we find the source of the cells for you. We have access to hundreds of different primary cells and a variety of stem cells as well.
The establishment of compliant, robust, and traceable cell and viral banks are critical for GMP production. VxP Biologics manufactures and cryostores Master and Working Cell Banks to support present and future production requirements. Mammalian Cell Banks are cryostored in the vapor phase of liquid nitrogen freezers. Viral banking services are completely segregated from non-viral activities to ensure no cross-contamination of products. Validated changeover and cleaning procedures requiring Quality Assurance release of each suite prior to use ensures cell line integrity and minimizes adverse events and contamination. VxP Biologics manages and coordinates all required testing per FDA and ICH guidelines.
Mammalian Cell Banks
- Base master & working cell lines (eg. HEK-293, Vero)
- Stable recombinant protein/antibody expressing lines (CHO, NS/0, BHK-21)
- Human and non-human stem cells
Our experienced manufacturing team is well-equipped to execute mammalian cell culture production campaigns for your specific guidelines. With production capability in 250L or 1000L disposable bioreactors or in 100L, 500L, and 1000L stainless steel bioreactors, our independent trains of bioreactors can accommodate a majority of biologics drug substance requirements. As an alternative, single-use options are also available throughout all cell culture expansion and terminal bioreactor steps.
Purification & Bulk Fill
We have extensive experience with an array of purification capabilities to meet your cGMP production needs. Purification suites at VxP Biologics are segregated and customized with equipment to specifically meet the requirements of each client process. Single-use options are available throughout all purification steps with cutting-edge technologies to increase efficiency and shorten project timelines. Personnel in the purification team at VxP Biologics are experts with multiple chromatography techniques, including tangential flow filtration, and bulk drug substance filling per cGMP guidelines.