QBI has expertise in optimizing cell culture conditions, culture media formulations, and serum-free culture conditions for both anchorage-dependent and suspension systems.
Cell Culture Media Contract Manufacturing
Outsource to a dependable media contract manufacturing partner. All products are manufactured under an ISO 9001:2015 certified and GMP-compliant quality management system. We provide high-quality buffers, reagents, and cell culture solutions designed to meet the stringent demands of preclinical and drug development research. Our rigorous quality control processes ensure consistency and reliability, giving your team the confidence needed for reproducible results.
Cell Culture Media Contract Manufacturer Services
The development and verification of scale-up manufacturing processes as well as qualified analytical methods are fundamental to the development and commercialization of any research 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 an ISO 9001:2015 certified quality management system (QMS). Our facility is equipped with a comprehensive suite of commercial-scale aseptic filling capabilities. We offer aseptic filling for a wide range of volumes (microliters to liters) in a variety of containers (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. Services include plasmid amplification and purification, protein expression and purification, from stable cell lines or by transient transfection. We use commercially available cell lines for transient transfection and commercial resins for purification, so QBI does not retain ownership. 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 provides comprehensive cold and cryostorage solutions for various specimens, including blood, sera, plasma, cells, and viruses. We offer temperature-controlled short and long-term storage options, including liquid nitrogen vapor phase, ultra-low (-80°C) freezers, standard frozen (-20°C) storage, refrigeration (4°C), and controlled ambient conditions. Our services accommodate thousands of samples in various formats. We implement lifecycle management solutions to ensure sample integrity and traceability, including high-quality collection tubes, controlled-rate freezing, and monitored shipping conditions. Our freezers and equipment are monitored 24/7 with alarm systems and on-call personnel to respond to emergencies.
Cell Culture Process Development
Quality Biological demonstrates expertise in cell culture process development through its tailored approach to media production, emphasizing the precision and adaptability of our manufacturing process. Our expertise extends beyond creating custom cell culture media, focusing on engineering solutions that seamlessly integrate into your operational workflows.
Our process-driven strategy is built on rigorous quality control and adaptive scalability. We understand that each scientific endeavor has unique requirements, which is why we develop comprehensive solutions precisely aligned with your project objectives. As your development partner, we ensure our processes are tailored to meet your specific needs, reflecting our commitment to delivering the highest quality products.
Flexibility is the core of our service offering. We provide an extensive range of packaging options – from 1 mL vials to 200 L bioprocessing bags – with private-label manufacturing capabilities. Whether supporting small-scale laboratory research or large bioprocessing initiatives, we deliver products designed to enhance your scientific workflows and drive research success.
Quality and Compliance
Quality Biological has an unwavering commitment to quality manufacturing. We collaborate closely with our clients to develop and scale manufacturing strategies that meet rigorous quality requirements and industry standards. Our dedication to excellence is evident in our ability to provide the highest quality products enhanced by personalized service and flexibility.
Quality Biological’s manufacturing capabilities ensure that from raw material sourcing to finished product, each step is optimized for quality and reproducibility. This approach meets and often exceeds the expectations of our partners, consistently delivering results that drive successful project outcomes.
Every batch of product is provided with a certificate of analysis (COA). Our comprehensive COAs detail the specifications, results, and compliance of our products, ensuring transparency and confidence in their quality. Customizing COAs for private-labeled products is part of our service, allowing clients to seamlessly integrate their branding and meet their specific documentation needs.
If you have specific requirements or wish to explore how customization can support your brand’s needs, contact us.
Process Workflow
Pure Results.
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 the product formulation, packaging, customized the manufacturing fill and finish process, and completed validation in 9 months.
Results: The customer met the on-time launch deadline of the new instrument.
Challenge: A 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 reviewing the data generated by the pilot lot, the customer revised production requirements to those proposed by QBI and signed a supply agreement with us for the production of commercial lots.
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Let us help you streamline your research with solutions that work for you.