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Cell Line Development

Viewing related articles

Genetic characterization/ stability and regulatory aspects of cell line stability – Survey one

Genetic characterization/ stability and regulatory aspects of cell line stability – Survey one

Oct 2021 | Benchmarking, Cell Line Development, Development Group

Survey examining the types of testing conducted and included in filing and research looking at companies’ approaches to setting and using acceptance criteria.

read more
Genetic characterization/ stability and regulatory aspects of cell line stability – Survey one

Genetic characterization/ stability and regulatory aspects of cell line stability – survey two

Oct 2021 | Benchmarking, Cell Line Development, Development Group

The second member only survey from the Cell Line Development workstream gathering information on the genetic characteristic and stability of cell lines.

read more

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  • Supply Partner
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  • Buffer stock blending system
  • Change Notification
  • Closure playbook
  • Cyber security
  • Digital integration of sponsor and contract organizations
  • Digital plant maturity model
  • Extractables and leachables
  • Forecast and demand planning
  • In-Line Monitoring and Real-Time Release
  • IT for cell and gene therapies
  • Knowledge Management
  • Lab of the future
  • Raw materials
  • Single-use systems
  • Sterile Filtration QRM & PUPSIT
  • Technology adoption

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Phorums

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  • Cell & Gene Therapy
  • Development Group
  • Drug Substance
  • Fill Finish
  • Information Technology
  • MedTech
  • Regulatory
  • Supply Chain to Patient
  • Supply Partner
  • Sustainability
  • Technology Roadmapping

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