Thursday November 21, 2024
  • |Subscribe
  • |Contribute
  • |About
  • |Access Your Account
  • |Register
  • |Login
  • |Home
  • |Issue Archive
    • |Featured Reports
    • |eBooks
  • |BioProcess Insider
  • |Multimedia
    • |BPI White Papers
    • |Webinars
    • |Posters
  • |BioProcess International Events
    • |BioProcess International US West
    • |BioProcess International Europe
  • |BioProcess International Academy
  • |Events

BioProcess International

Covering the whole development process for the global biotechnology industry

  • Upstream
    Processing
    Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.
    • Assays
    • Biochemicals/Raw Materials
    • Bioreactors
    • Cell Culture Media
    • Expression Platforms
    • Fermentation
    • Perfusion Cell Culture
    • Upstream Contract Services
    • Upstream Single-Use Technologies
  • Downstream
    Processing
    Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.
    • Filtration
    • Separation/Purification
    • Viral Clearance
    • Chromatography
    • Downstream Contract Services
    • Downstream Single-Use Technologies
  • Manufacturing
    Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.
    • Personalized Medicine
    • Single Use
    • Supply Chain
    • Vaccines
    • MAb
    • Biosimilars
    • Cell/Gene Therapies
    • Emerging Therapeutics
    • Facility Design/Engineering
    • Continuous Bioprocessing
    • Fill/Finish
    • Formulation
    • Information Technology
    • Manufacturing Contract Services
    • Process Monitoring and Controls
  • Analytical
    Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.
    • Culture Development
    • Cell Line Development
    • Downstream Development
    • Downstream Validation
    • Laboratory Equipment
    • PAT
    • Pre-Formulation
    • Product Characterization
    • QA/QC
    • Upstream Development
    • Upstream Validation
    • Leachables/Extractables/Particulates
  • Business
    Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.
    • Careers
    • CMC Forums
    • Economics
    • Intellectual Property
    • Pre-Clinical and Clinical Trials
    • Regulatory Affairs
    • Risk Management
    • BioRegions

Validation Issues for Disposable Manufacturing

View PDF
by BPI Contributor Friday, October 1, 2004  9:00 am

Categories: 2004, Downstream Validation, October 2004 Supplement, Upstream Validation

View PDF
← Older Post Newer Post →

Editor’s Choice

  • BioProcess Insider

    Quell and Cellistic partner to develop cell therapy platform

  • BioProcess Insider

    Shingrix sales bounce back post-pandemic for GSK

  • Sponsored Content

    Product Quality in Focus

  • BioProcess Insider

    Danaher and Sartorius: COVID just one variable affecting bioprocess growth

  • BioProcess Insider

    Thermo Fisher opens $44m single-use Utah plant

  • Sponsored Content

    The Critical Role of Predictive Bioreactor Characterization in Pharmaceutical Process-based Upscaling

BioProcess Insider News and Analysis

Recent Tweets

  • Tweet Avatar Great panel discussion about the security of supply chains at the BPI Theatre #BPIWest https://t.co/rMFdNpHjhM 2 years ago
  • Tweet Avatar We’re at #BPIWEST, 2023! 2 years ago
  • Tweet Avatar What a great event #cphi2022 - see you in Barcelona next year! 2 years ago
  • Tweet Avatar We’re here & ready for the second day at #CPHI in Frankfurt! 2 years ago
Follow @bioproinsider

Explore Topics

  • Upstream Processing
  • Downstream Processing
  • Manufacturing
  • Analytical
  • Business

Publication

  • Issue Archive
  • Featured Reports
  • eBooks
  • Subscribe
Connect
Privacy policy

BioProcessIntl.com

  • White Papers
  • Posters
  • Webinars
  • BPI Theater
  • Awards
  • Register
  • Login
  • Access Your Account

Keep up with BPI

  • Email Newsletters
  • Events
  • BioProcess Insider
  • Twitter
  • LinkedIn

About BPI

  • Who We Are
  • Editorial Advisors
  • Author Guidelines
  • Advertising/Media Kit
  • List Rental/Reprints
  • Contact Us
  • Careers
BPI
twitter linkedin
Site Map|Contact
©2024 BioProcess International All Rights reserved
  • Home
  • Issue Archive
    â–¼
    • Featured Reports
    • eBooks
  • BioProcess Insider
  • Multimedia
    â–¼
    • BPI White Papers
    • Webinars
    • Posters
  • BioProcess International Events
    â–¼
    • BioProcess International US West
    • BioProcess International Europe
  • BioProcess International Academy
  • Events