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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
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Featured Content
Podcast: On board the Cell Shuttle with Cellares
Cellares Corporation’s CEO Fabian Gerlinghaus talks about the limitations in cell therapy production and its Cell Shuttle technology.
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Top Trends in Biomanufacturing
A BioPlan Associates report on biopharmaceutical manufacturing projects that market growth will be steady but suppressed by demand for staff.
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Reducing Risk in Bioproduction with Facilities Equivalency
Sponsored
Establishing facilities equivalency across biomanufacturing sites helps to ensure consistent production of high quality cell culture media.
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Evaluation of a Novel Peptide-Based Affinity Ligand for Human IgM Purification: Use of an Automated Liquid-Handling System for Rapid Assessment of Binding Kinetics and Capacity
Recent introduction of novel affinity ligands has enabled single-step IgM purification, opening up new therapeutic applications.
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Exploring Resin Modalities for Biotherapeutic Purification
Sponsored
Learn how resin functionalities can maximize yield and improve process economy, helping manufacturers to deliver low-cost biologics to patients with unmet medical needs.
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Advanced Analytics to Accelerate Development of Genetic Vaccines
Sponsored
Genetic vaccines, including those developed for COVID-19, require advanced analytical methods that can confirm vector structure and purity.
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Cold-Chain Validation: Emerging Vaccines for COVID-19 and Beyond Require More Extensive Evaluation
Cold-chain engineers are working alongside drug companies to ensure COVID-19 vaccines ship quickly without compromising safety and quality.
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eBook: mRNA — Revisiting a Technology That Has Rocketed into Success
Since the emergence of COVID-19, the biopharmaceutical industry has learned much about manufacturing and formulating mRNA drug products.
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Issue Archive
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Featured Reports
eBooks
BioProcess Insider
Multimedia
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BPI White Papers
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Posters
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BPI Conference & Exhibition – HYBRID
Cell & Gene Therapy US HYBRID
BioProcess International Academy
Events
