Search results for " regulatory" in Posters
Poster
Reduce Risk of Failure in Your Virus Clearance Study by Choosing Robust Scale-Down Chromatography Tools
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. Vi…
Poster
Perfusion Media Development for Scalable Processes
Cell culture perfusion processes are considered optimal for a truly integrated continuous biomanufacturing pipeline. The nutrient-rich but balanced media should be designed to support very low cell-sp…
Poster
Repurposing Fed-Batch Media and Feeds for Highly Productive CHO Cell Perfusion Processes
The authors developed a method for identifying first-generation perfusion culture media based on existing fed-batch media and feeds. Here, they show that they can obtain culture media that successfull…
Poster
Strategies for optimized cell culture media: Effectively using design space to influence product quality
Effective biopharmaceutical production is achieved in part through target-specific, quality-optimized cell culture media. Balancing the many individual media components required to achieve high tite…
Poster
Case Study: Improve Process Economy by Cycling of Prepacked Chromatography Columns
The use of disposable technologies in downstream processing has increased significantly over the last years, as they reduce the need for time-consuming cleaning and cleaning validation operations as…
Poster
Heating-cooling and liquid-liquid mixing characterization at a range of volumes
In a biopharmaceutical plant, more that 50% of the operation is mixing or hydration. Single-use mixers have been used in the past two decades in biopharmaceutical plants to replace the use of stainl…
Poster
Improve operational efficiency in biomanufacturing with comprehensive automation solutions
In the biopharmaceutical industry, process data is used in multiple ways throughout process development and the different production phases. However, equipment used are often connected only by proce…
Poster
Residual DNA analysis in influenza vaccine processing
In cell-based influenza vaccine production, the European Pharmacopoeia demands a host cell residual DNA concentration of less than 10 ng per dose. To reliably measure residual DNA in both process sa…
Poster
Biacore™ systems in vaccine development and production
The growing public awareness of a potential pandemic requiring rapid treatment of millions of healthy individuals has spurred renewed interest in vaccines. Vaccination campaigns mean that often very…
Poster
Process economy and production capacity using single-use versus stainless steel fermentation equipment
This white paper compares production capacity and process economy between stainless steel and single-use equipment in microbial processes. Economy simulations were based on an E. coli Dab process. P…