Search results for " documentation" in Articles / App Notes

Article Setting Up Bioprocessing Systems for Digital Transformation
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern. By Feliza Mirasol The advancement of digit…

Article Traceability in Western Blot Imaging: Considerations for GxP
LEARN MORE >> Densitometry analysis of gels is a key part of quality control in the pharmaceutical drug release process. In regulated environments, electronic record-keeping can improve both tra…

Article Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
By establishing effective management of data and knowledge, it will be possible to employ advances, such as artificial intelligence and synthetic biology, to their full potential in upstream bioproc…

Article Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar. By Cynthia A. Challener …

Article The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…

Article Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…

Article Single-Use for Downstream Chromatography: Benefit or Hindrance?
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption. By Feliza Mirasol ARTMOIS/STOCK.ADOBE.COM Biopharmaceutical manufactu…

Article Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …

Article A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals. …

Article The Challenge of Disruptive Technologies in Bioprocessing
Customers are demanding overall efficient, cost-effective solutions, faster, just-in-time service and delivery, supply chain logistics, full [good manufacturing practice] GMP documentation, high consi…

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