Search results for " documentation"
Webcast
Establishing a CHO-K1 cell line and cell line development process for biotherapeutics markets
But how can you meet rapid timelines when the cell line development workflow is challenged by documentation needs, commercial use rights, and regulatory scrutiny?
Join Cytiva’s webinar on February…
Article
Webinar: Establishing a CHO-K1 cell line and cell line development process for biotherapeutics markets
But how can you meet rapid timelines when the cell line development workflow is challenged by documentation needs, commercial use rights, and regulatory scrutiny?
Join Cytiva’s webinar on Febru…
Article
Current Techniques and Challenges Presented in Scaling Between Bioreactors
cell culture
In this video, Andreas Castan, Strategic Technology Partnerships Leader at Cytiva, discusses the current techniques and challenges in scaling between bioreactors.
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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
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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…