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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/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
April 2004 Supplement
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
Resources for Further Reading
by
BPI Contributor
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