The Bigfinite Bioreactor Application: Solving Key Data Challenges Facing Biotech and Pharmaceutical Firms
This paper will explore the most important data challenges experienced by the rapidly modernizing pharmaceutical industry and propose a GxP-compliant, ready-made application as a solution designed to increase efficiency in upstream processes, while maintaining data integrity and compliance.
Upstream processes are one of the fastest evolving technologies available for the production of medicinal products. Traditional production methods using batch or fed-batch bioreactor systems are evolving to provide continuous manufacturing with single-use technologies. Controlling process parameters can be difficult for pharma teams who cannot analyze the large amount of data in real time. Traditionally, process experts tend to analyze a limited number of critical process parameters (CPPs) in a limited scenario. Pharma companies often lack the tools to pay close attention to all critical factors which could directly or indirectly affect the safety, the potency, the impurity profile and the quality of medicinal products from the initial entrance of raw and starting materials to manufacturing sites, to the drug product’s final packaging. Few solutions meet these complex requirements