Wednesday June 07, 2023
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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
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Featured Content
Voices of Biotech: Bristol Myers talks diverse leadership
When it comes to hiring, there is not enough diversity at upper leadership levels says Vibha Jawa from Bristol Myers Squibb.
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eBook: Working Together Is Key to Bioprocess Sustainability
Biopharmaceutical developers and industry suppliers must collaborate if they are to achieve ambitious bioprocess sustainability initiatives.
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Digital Transformation in Biopharmaceutical Operations
The biopharmaceutical industry can embrace digital transformation, as consumer products become digitalized, to meet changing product demands.
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Addressing Gaps in US Biomanufacturing Capacity
The PCAST biomanufacturing report identified key concerns that include regulatory uncertainty, outdated strategies, and a lack of capacity.
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High Precision: Automated Aseptic Filling of Small Volumes
Sponsored
Automated aseptic filling of drug substances into single-use containers simplifies manufacturing, while improving throughput, speed, and filling accuracy.
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Hybrid Design Considerations in Biomanufacturing: Leveraging Both Stainless-Steel and Single-Use Systems
Biopharmaceutical companies are developing hybrid manufacturing facilities, as single-use process flows are not always possible or desirable.
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Viral Safety for Biotechnology Products, Including Viral Vectors: ICH Q5A Revision 2 Brings Updated and More Comprehensive Guidance
The ICH Q5A Revision 2 includes new product types including viral-vector-derived products, continuous manufacturing, and prior knowledge.
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Development of an IEX Purification Process for Lentiviral Vectors
Sponsored
Learn about high-throughput screening employed for LVV IEX purification processes which provide high yield and acceptable HCP clearance.
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Issue Archive
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Featured Reports
eBooks
BioProcess Insider
Multimedia
â–¼
BPI White Papers
Webinars
Posters
BioProcess International Events
â–¼
BioProcess International Conference & Exhibition
Cell & Gene Therapy Manufacturing & Commercialization US
Well Characterized Biologics & Biological Assays
Cell & Gene Therapy Manufacturing & Commercialization Europe
BioProcess International Academy
Events
