BioFactura’s biopharmaceutical industry experience is grounded in bioprocess development, scale-up, and manufacturing. The Company has capabilities to develop a broad range of upstream bioprocesses in mammalian cell culture expression systems. This includes the development of expression vectors and cell lines through medium optimization and process scale-up. BioFactura is also highly experienced in developing downstream recovery and purification processes. Steps may include centrifugation, depth and micro/ultra-filtration, and chromatography (affinity, ion-exchange, hydrophobic interaction). The Company is also well versed in developing and performing in-process and release analytical assays including various HPLC methods, SDS-PAGE and Western analysis, antibody/antigen capture ELISAs, purity assays (endotoxin, HCP, residual protein A), and bioactivity methods.
BioFactura’s facilities are located at 8435 Progress Drive, Suites Y-Z in Frederick, Maryland. The laboratory space is segregated into a general research lab, an analytical lab, and three cGMP suites at ISO 8 and 7 classification: A cell culture suite (ISO 7: 200 sq. ft.); a bioreactor suite with 250L and 1000L single-use bioreactors (upstream, ISO 8: 235 sq. ft.); and purification suite (downstream, ISO 7: 300 sq. ft.). All critical environmental and process parameters are electronically monitored by a compliant Facility Monitoring System (FMS). Environmental monitoring (EM) is outsourced during cGMP campaigns. All process equipment and bioprocesses utilize full single-use technology such that all product contact surfaces are disposable and no cleaning or in-house sterility validation is required. This delivers high flexibility, rapid changeover, and low failure risk for clinical manufacturing campaigns.