Contract Manufacturing

QBI has expertise in optimizing cell culture conditions, culture media formulations, and serum-free culture conditions for both anchorage-dependent and suspension systems. Services include plasmid amplification and purification, protein expression and purification, and recombinant protein expression by transient transfection (from 30 ml to >20 Liters).

The development and validation of scale-up manufacturing processes as well as validated analytical methods are fundamental to the development and commercialization of any biopharmaceutical product. QBI’s expertise includes formulation development for scale-up, stability assessment, and custom assay development for performance and quality control.

QBI is a manufacturing enterprise operating under ISO 9001:2015. Our facility is equipped with a comprehensive suite of aseptic filling capabilities at commercial scale. We offer aseptic filling for a broad range of volumes (microliters to liters), in a broad range of containers (glass and plastic tubes, square and round bottles, bioprocessing bags, ampules, jars, plates). Contact us to evaluate your specific needs in vialing reagents, solutions, and kits.

QBI offers a gene-to-antibody production and purification service platform. We use commercially available cell lines for transient transfection and commercial resins for purification so QBI does not retain any ownership. We offer production scales ranging from 0.03 liters to 20+ liters. Our expertise in glycoprotein production serves to deliver high-quality monoclonal antibodies with optimal glycosylation, a critical factor for product solubility, stability, pharmacokinetics, pharmacodynamics (PK/PD), bioactivity, and safety, minimizing potential immunogenicity.

The composition and quality of the fluids are critical to operate and maintain your flow cytometry system and Quality Biological, Inc. provides the solutions you need. The composition and high quality of the solutions are designed to prevent salt crystal buildup and bacterial growth in fluidics lines. Operate your flow cytometry system confidently knowing that the critical steps, such as startup, shutdown or routine cleaning cycles will not prevent data collection due to impaired fluidics lines. We have experience in manufacturing any volume of cell staining solution, fixation buffer, wash buffer, lysis buffer, binding buffer and FACS buffer.

QBI’s biorepository program meets all of your short and long-term cold and cryostorage requirements. QBI biorepository offers a range of refrigeration and frozen storage options for various specimens (to name a few: blood, sera, plasma, and viable mammalian cells and viruses) as well as controlled ambient storage. Services are available for specimens requiring liquid nitrogen vapor phase temperatures (<-170°C), ultra-low (-80°C) temperatures, standard -20°C and 4°C storage temperatures, and ambient storage which can accommodate thousands of vials, bottles, containers of different sizes and shapes. QBI uses integrated and comprehensive sample lifecycle management solutions including high-quality collection tubes and controlled-rate freezing for sample integrity and monitored shipping conditions for the protection of valuable samples. Temperatures on all freezers and equipment are continually monitored 24-7 by an alarm system, and trained biorepository personnel are always on call to respond in the event of an emergency.