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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: Industry veteran moves to Lykan Bioscience, and this time its personal!
The BioProcess Insider Expression Platform explores the evolution of cell and gene therapies with COO of Lykan Bioscience, Patrick Lucy.
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From Target to Hit: The WuXi HitS Platform
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WuXi's HiTS business unit has constructed >200 DNA-encoded libraries displaying >90 billion different small-molecule structures.
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G-Protein–Coupled Receptors: Promising Targets for Antibody–Drug Conjugates
Improved understanding of the structure and function of GPCRs in cancer is accelerating development of novel ADCs for cancer treatment.
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eBook: Biomarkers — Improving Clinical Studies to Enhance Commercial Success for Biologics
Finding predictive biomarkers for cancer and autoimmune diseases could help drug companies hone clinical trials and improve patient outcomes.
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Drug Formulations Are Changing:
New Sterile Filtration Challenges in the Changing Landscape of Drug Formulations
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Complex drug formulations are raising sterile filtration challenges that require new strategies for meeting process development timelines.
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Manufacture and Regulation of Cell, Gene, and Tissue Therapies, Part 1: Chemistry, Manufacturing, and Control Challenges
An adequately controlled system for raw materials, starting materials, and reagents is the foundation for manufacturing of ATMPs.
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Innovations in the Manufacturing of Cell and Gene Therapies
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Integrating platforms for development, testing, manufacturing, and commercialization can accelerate time to market and can be achieved by advanced therapies contract manufacturing.
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Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 2: Process Modeling and Analytics
Advancements in data analytics and process modeling are driving efforts to transform biopharmaceutical process control strategies.
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Featured Reports
eBooks
BioProcess Insider
Multimedia
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Webinars
Posters
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BioProcess International West
COVID-19 Therapeutic Development & Production
BioProcess International Academy
Events
