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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
Asahi Kasei enters CDMO biz with Bionova buy
Through the acquisition of Bionova Scientific, the US arm of Asahi Kasei Medical will add a full-service biologics CDMO to its arsenal.
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eBook: Potency Bioassays — Development, Trending,
Transfer, and Automation
Bioassay development is infamously complex, requiring careful consideration of variability potential, system suitability, statistical models.
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Establishing a Digital Platform for Data Science Applications in Biopharmaceutical Manufacturing
Due to the complexity of integrated systems, digital platforms must be established to facilitate rapid development and implementation of models by data scientists.
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Pathogen Safety Digital Platform for Biopharmaceuticals: The Journey from Ground to Cloud
In the context of biopharmaceutical process development, digital twins can help streamline and accelerate experiments including pathogen safety.
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Reducing Cell and Gene Therapy Development Time and Cost with New Purification Strategies
Sponsored
Using new purification strategies to reduce development time and cost of cell and gene therapy.
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Addressing Critical Issues in Cell and Gene Therapy Manufacturing
Sponsored
Read about the evolution of gene therapy manufacturing and improved GMP raw-material sourcing for more efficient transient transfection.
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Get High-Throughput, Definitive Identification of Viable Cells and More in Your Cell Therapy
Sponsored
Learn how to characterize SVPs and get high-throughput and definitive identification of viable cells with Aura CL system for cell therapies.
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Patent Thickets Constrain US Biosimilars Market
Learn about patent thickets and how they work, how they can be abused, and potential domestic manufacturing implications in the US biosimilars market.
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