Biomanufacturing Process Development
Process Development & Scale Up
Design and optimization of production scale-up (including pilot plant operations) requires careful testing and monitoring using a wide range of different techniques.
Monoclonal Antibody (mAb) Purification
mAb purification relies heavily on chromatography. Each resin works within a set of parameters. These purification steps include capture, intermediate and polishing that remove a wide range of contaminants including host cell proteins (HCPs) host cell DNA aggregates, and other contaminants from your mAb therapeutic.
Vaccine & Gene Therapy Development
Vaccines and gene delivery systems (viral vectors) are often developed from virus and virus-like particles (VLP). Virus purification comes with a unique set of challenges. They are commonly purified using chromatography resins in a single or multiple purification steps.
Biologics such as recombinant proteins, antibodies, and antibody derivatives are transforming the healthcare landscape by offering targeted therapies to patients. These biomolecules are purified using resin based chromatography techniques. This workflow includes multiple steps from capture to polishing to achieve the target purity and quality.
Pharmaceutical Manufacturing & Release Testing
Ensure Quality Across Workflows
Employing good manufacturing practices (GMPs) including workflow adherence, record-keeping, and quality assurance throughout your manufacturing process is vital to safe pharmaceutical release.
Chromatography Resins for Biomanufacturing
Bio-Rad offers a wide selection of innovative bioprocess chromatography resins, media and tools providing process developers with flexibility and high productivity to meet the demands of downstream purification processes.
Manufacturing, QC & Patient Monitoring
Key Tools for Manufacturing, QC & Patient Monitoring
Commercial scale manufacturing requires constant QC and monitoring to comply with the rigorous standards of patient care. Key tools contribute to successful manufacturing and better patient safety.
Once your candidate drug is ready for human testing, it undergoes a rigorous progress where it is closely evaluated for safety and efficacy in treating, preventing, or diagnosing a specific disease or condition. Because the safety of trial participants is the most important consideration, all testing occurs in FDA-supervised phased clinical trials, along with further assays to characterize absorption, distribution, metabolism, excretion, and toxicity.
Drug Discovery & Development
Consistency, reproducibility, and reliability are critical to accelerating your drug discovery and development journey from target identification through scale-up manufacturing. In order to maintain the highest quality standards and productivity, choose products that automate your workflow, and reduce hands-on time, so you can focus on your most critical tasks.
Translational Research takes scientific discoveries made in the laboratory, the clinic, or in the field, and transforms them into new medical treatments and approaches that improve human health. The process of applying discoveries generated during lab and preclinical research to human clinical trials, requires work to ensure quality including validating biomarkers, optimizing therapeutics for safety and efficacy, and determining the best purification processes and formulations for human trials.