05Nov
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 highly proficient in continuous perfusion bioreactor production processes that can increase working volume yields by over 5-fold as compared with fed-batch mode. The Company also highly experienced in developing downstream recovery and purification processes. Steps may include centrifugation, depth and micro/ultra-filtration, and chromatography (affinity, ion-exchange, mixed mode). BioFactura excels in developing, qualifying 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. The Company also has high-resolution characterization capabilities including LC-MS/MS and Octet/BLI.
BioFactura’s facilities are located at 8435 Progress Drive, Suite Z in Frederick, Maryland. The laboratory space is segregated into a process development lab, an analytical development and quality control lab, and cGMP suites at ISO 8 and 7 classification: An upstream cell culture/bioreactor suite (200L production bioreactor, ISO 8); and a downstream purification suite (AKTAReady chromatography system, ISO 7).
BioFactura’s entire operation is grounded and governed by an independent Quality Assurance department employing a comprehensive Quality Management System (QMS). All critical environmental and process parameters are electronically monitored by a compliant Facility Monitoring System (FMS). Environmental monitoring (EM) and critical cleaning are continuously maintained. 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.