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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.
Biosimilars
Cell/Gene Therapies
Continuous Bioprocessing
Emerging Therapeutics
Facility Design/Engineering
Fill/Finish
Formulation
Information Technology
MAb
Manufacturing Contract Services
Personalized Medicine
Process Monitoring and Controls
Single Use
Supply Chain
Vaccines
Validation
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
2004
On-Line TOC Analyzers Are Underused PAT Tools
by
BPI Contributor
Heterologous Protein Production in P.fluorescens
by
BPI Contributor
Extreme Bioprocessing
by
BPI Contributor
Chromatography Advisor #2
by
BPI Contributor
A Rose By Any Other Name?
by
BPI Contributor
Compliance Issues for Innovator and Generic Biopharmaceuticals
by
BPI Contributor
Products, Services, and Literature
by
BPI Contributor
BPI Reports
by
BPI Contributor
The FDA Changes Labeling Submission Requirements
by
BPI Contributor
Partnering with Your CMO for a Successful Preapproval Inspection
by
BPI Contributor
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