VxP Biologics has extensive experience with multiple bioprocess routes, including batch and fed-batch fermentation of E. coli and Pichia. Fermentation procedures are established in process development and scaled-up for cGMP operations in our state-of-the-art facility. Our manufacturing team works in close coordination with the tech transfer group to ensure a seamless transition from lab-scale to clinical production.
Cell and Virus Banking
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. 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.
Viral Cell Banks
- Viral Seed Stocks
- Viral vectors for gene delivery (adenovirus, retrovirus, lentivirus, AAV, others)
- Viral vectors for vaccines (live, attenuated, and whole-killed)
- Banking/vialing of purified phage
Our manufacturing team is highly experienced in bioreaction technology and has an excellent track record with process-scale fermentation. With production capacities in 10L, 100L, 200L or 1000L stainless steel vessels, our fermenters can accommodate the majority of your microbial biologics production campaigns. Fermentation experts at VxP Biologics routinely work with and design a wide range of feed strategies, media formulations, and inclusion body recovery techniques.
Purification & Bulk Fill
We have extensive experience with an array of purification capabilities to meet your cGMP production needs. Purification suites 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 are experts with multiple chromatography techniques, including tangential flow filtration, and bulk drug substance filling per cGMP guidelines.
Contact us today for a free consultation about your Biologics program today.