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Friday January 22, 2021
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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

Events

  • January 2021
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  • December 2021
  • Tue
    26
    Oct
    2021
    Thu
    28
    Oct
    2021

    Well Characterized Biologics & Biological Assays

    Hyattsville, Maryland

    The leading event to ensure CMC, regulatory success and expedited product approval. Gain Practical Advice From Case Studies, FDA & Regulator …


xxTweets by @BioProcessIntl

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