Pure Results.

Our Research and Development team is available for your outsourcing projects. We will be your partner to guarantee a successful transition of technology from the laboratory bench to a scale-up process within a commercial production environment. We identify and validate raw material providers for quality, cost-effectiveness, regulatory compliance and supply reliability. We will work closely with you to address your specific needs and requirements, and we will deliver a product that is yours to use; we do not retain any ownership.

Our clients range from small start-up companies to global pharmaceutical giants and everything in between. We have experienced staff with over 40 years industry experience in process development, validation and bulk manufacturing. All products are produced under a cGMP compliant Quality System in an ISO 9001:2015 certified facility.

Featured Services:

Aseptic Processing
Quality Biological is a manufacturing enterprise operating under ISO 9001:2015. Our facility is equipped with a comprehensive suite of aseptic filling capabilities at commercial scale. Our clean rooms are certified in accordance with ISO-14644-1 and IEST-RP-006.3 as ISO Class 5. 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, ampules, jars, plates). Contact us to evaluate your specific needs in vialing reagents, solutions, kits.

 

Monoclonal Antibody (mAb) Production and Purification
QBI offers a gene-to-antibody production and purification service platform. We have an extensive experience in protein production in mammalian cell systems, by transient transfection or from stable cell lines. 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 and pharmacodynamics (PK/PD), bioactivity, and safety, minimizing potential immunogenicity.

 

Flow Cytometry Fluidic Solutions
The composition and quality of the fluids are critical to operate and maintain your flow cytometry system and Quality Biological 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.

 

Repository Management
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 (<-160°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 an integrated and comprehensive sample lifecycle management solutions including high quality collection tubes and controlled-rate freezing for sample integrity, barcode identification for traceability and monitored shipping conditions for 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.

 

Cell Culture Services, Biomanufacturing
Services include plasmid amplification and purification, protein expression and purification, analytical and biological characterization of recombinant proteins. QBI offers recombinant protein expression services by transient transfection (from 30 ml to >20 Liters) or by stable cell line development. QBI has expertise in optimizing cell culture conditions, culture media formulations, serum-free culture conditions for both anchorage-dependent and suspension systems.

 

Process Development
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.

 


Case Study: Product Development

Challenge: A large bio-biopharmaceutical company needed to launch a new instrument that required fluidics into the cell biology market. The immediate challenge was the need to deliver a solution quickly as the device had high expectations for launch.

Solution: QBI developed product formulation, packaging, customized the manufacturing fill and finish process, and completed validation in 9 months.

Results: The customer met on-time launch deadline of the new instrument.

Case Study: Process Development

Challenge: Start-up biotechnology company approached us for large-scale manufacturing of a reagent they had only prepared at a small scale in their lab.

Solution: QBI proposed a pilot lot production to work out conditions (mixing time, exposure to light, filling and packaging), QC requirements (type and schedule of QC tests, product performance determined by cell-based assay), storage and shipping conditions (room temperature vs. ice packs), and cost based on material and production conditions.

Results: After review of data generated by the pilot lot, the customer revised production requirements to those proposed by QBI and signed a supply agreement with us for production of commercial lots.


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