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BioProcess International

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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Application of an Effective In-Line Analytical Instrument for Biopharmaceutical Development and Manufacture

Sponsored The CTech FlowVPX analytical instrument is an in-line system that can fulfill industry demands, while foregoing human error and solving new challenges.

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Ask the Expert Webcasts

On-Demand Webcasts

  • Flexible and Customized Approach to Lentiviral Vector Development and Manufacture Through a Well-Established Platform
  • Shaken, Not Stirred: Rocking Motion Versus Impeller Technology and What is Optimal for Cell Cultivation

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BioProcess International BIO Theater

@bioprocessintl Tweets

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Upstream Processing

Quantitative Synthetic Biology for Biologics Production

Shear-Proof Design Space: Scaling Stirred-Tank Bioreactors for Cell Culture Processes

See all in Upstream Processing

Downstream Processing

Chromatographic Purification: Data Science, Chemistry, and Process Engineering Are Driving Bioprocess Innovation Forward

Demystifying Mixed-Mode Chromatography Resins: Emerging Applications for Purification of Non-MAb Protein Therapeutics

See all in Downstream Processing

White Papers

The Powers of Odin: Comprehensive Cellular Characterization

Scalability from Mobius® 3 L Single-Use Bioreactor to 50 L – 2000 L Mobius® iFlex Bioreactors to Support Intensified Upstream Process Development

Your Ultimate Guide to Raw Materials Testing Support

Simplifying the Antibody Drug Conjugate Supply Chain: One company’s mission to drive efficiencies and mitigate CMC development and manufacturing challenges

Automated Aseptic Aliquoting: Unprecedented Flexibility For Good Filling

Standardization is Key: Unlocking the Potential of Data-Driven Maintenance

Xeno-free T cell Expansions in PBS Mini Vertical-Wheel® Bioreactor Using CellGenix® reagents

Current and Emerging Technologies to Optimize mRNA Manufacturing

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Manufacturing

Principles of Sustainable Development: Establishing a Successful Framework To Drive Change

Designing Single-Use Facilities for Biomanufacturing Expansion

See all in Manufacturing

Analytical

Continued Process Verification: A Multivariate, Data-Driven Modeling Application for Monitoring Raw Materials Used in Biopharmaceutical Manufacturing

Specification Limits for Biomanufacturing Processes: Comparing Tolerance-Interval and Process-Capability Methods

See all in Analytical

Posters

Accelerating Cell Line Development with an Efficient, Combined Platform Approach

Kuhner TOM For Off-Gas Analysis in Shake Flasks

Evaluation Of a New Glucose Control Strategy Using CITSens Bio APC (Automated Process Control) for CHO Fed-Batch Application

High Productivity and Process Economy in GxP Applications with the Octet™ Platform

Accelerate Cell and Gene Therapy Development and Manufacturing with Fully Integrated Closed CAR-T Cell Therapy Platform

Characterization Platform for Structural and Functional Feature Investigation of Bispecific Molecules

Automated Cell Line Development With Greater Than 99% Monoclonality On the Beacon® Platform

High Titer Recombinant Lentivirus and Adeno-associated Virus Production for Therapeutic Applications

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Webinars

The Use of Retrovirus-Like Particles (RVLP) to Evaluate Viral Clearance in Downstream Processing

Unlocking the Potential of CHO Cells: Advancing Bioproduction with Next-Generation Vector Design and Model-Guided Cell Line Development

Scalable AAV Vector Purification Workflow Using AEX and Mixed-Mode Chromatography

Accelerate Upstream Process Development With Data-Driven Feeding Strategy Optimization

Planova™ Webinar – Addressing Continuous Bioprocessing Challenges From Virus Removal Perspective

Highly Efficient Capture of Low Titer Fusion Molecule With Novel Protein A Membrane

Development of an IEX Purification Process for Lentiviral Vectors

Innovation of Novel Purification Strategies – A Case Study of a Clusterin Scavenger Resin

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