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#46142 (no title)
Analytical, Formulation and Quality
Cell Culture & Upstream Processing
Drug Product Manufacturing & Fill-Finish Processing
Early Stage Biologics and Companies
Manufacturing Strategy
Podcast Sponsors
Charter Medical
Fujifilm Diosynth Biotechnologies
Gyros
ILC Dover
Pall Life Sciences
Recovery & Purification
#60015 (no title)
Cell Culture & Upstream Processing
Recovery & Purification
Bioprocessing 4.0 – The Path to Smart Manufacturing
Analytical & Quality
Speed from Gene to Market
2018 BioProcess International Conference & Exhibition Pre-Event Planner
2014-07-10 PDF test 01
2016 BioProcess International Awards
Best Collaboration Finalists – 2016 BioProcess International Awards
Best Technology Application – ANALYTICAL Finalists
Best Technology Application – DOWNSTREAM Finalists
Best Technology Application – UPSTREAM Finalists
Corporate Citizenship Award Finalists – 2016 BioProcess International Awards
Emerging Company Finalists – 2016 BioProcess International Awards
Excellence in Facility Design or Retrofit Finalists – 2016 BioProcess International Awards
Excellence in Leadership Award Finalists – 2016 BioProcess International Awards
FAQs: BioProcess International 2016 Awards
Past Winners of BioProcess International Awards
A New Paradigm in Process Development: To Accelerate Biologic Manufacturing of MAbs, Vaccines, and Novel Biotherapies
Addressing High Demands for Increased Productivity in Downstream Operations
Advances in Single-Use Platforms for Commercial Manufacturing
April 2018 – Smart(er) Facilities: Automation and Innovation Can Take Bioprocessing to the Next Level of Intelligence
Biopharmaceutical Training Supplement
Bioreactors: Process Advances in Cell Culture and Fermentation
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Industry Innovators: 2018-2019
Upstream Processing — Industry Innovators: 2018-2019
Downstream Processing — Industry Innovators 2018-2019
Manufacturing — Industry Innovators 2018-2019
Analytical Methods and Instrumentation — Industry Innovators 2018-2019
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January-February 2019 Featured Report
March 2019 Featured Report: Addressing Challenges in Formulation
May 2017 Featured Report: Continuous Processes – Disposables Integrate Upstream and Downstream Processing
November 2018 Featured Report: The Biopharmaceutical Supply Chain
October 2018 Featured Report: Bioassays
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September 2018 Featured Report: Cell Line Development
State of the Industry – 2017 BioProcess International Special Issue
The Regulatory Affairs Perspective: Addressing Compliance in a Changing Industry – Chapter 5
The Supply-Chain Management Perspective: Managing Risks and Guarding Against Disruption – Chapter 6
The Bioexecutive Perspective: Business Strategies for a Rapidly Maturing Industry – Chapter 1
The Laboratory Manager’s Perspective: Ensuring Efficiency, Data Integrity, and Compliance
The Project Manager’s Perspective: Managing Timelines, Budgets, and Milestones in Multidisciplinary Teams – Chapter 3
The R&D Perspective: Mapping New Pathways from Discovery to Development – Chapter 4
The Process Development Perspective: Implementing Tools for Optimization – Chapter 7
The Manufacturing Perspective: Current Approaches to Bioprocess Intensification – Chapter 8
The Technology Transfer Perspective: Modern Approaches and Challenges – Chapter 9
The Engineer’s Perspective: Transforming Science into Technology – Chapter 10
The Analyst’s Perspective: Ensuring and Controlling Quality of Well-Characterized Biologics – Chapter 11
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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 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
April 2004 Supplement
Resources for Further Reading
by
BPI Contributor
Acknowledgments – Continuing Our Supplement Series
by
BPI Contributor
Chapter 1: The Human Immune System
by
BPI Contributor
Chapter 2: Classifying Vaccines
by
BPI Contributor
Chapter 3: Applying the Technology
by
BPI Contributor
Chapter 4: Vaccine Testing and Delivery
by
BPI Contributor
Chapter 5: The Two Global Markets
by
BPI Contributor
Glossary: The Language of Vaccines and Immunology
by
BPI Contributor
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