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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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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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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 Insider News and Analysis

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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

Viral Safety for Biotechnology Products, Including Viral Vectors: ICH Q5A Revision 2 Brings Updated and More Comprehensive Guidance

Understanding Viral Clearance During Anion-Exchange Chromatography: A Novel Design of Experiments Approach

See all in Downstream Processing

White Papers

Seven Steps to Build a Productive CDMO/Sponsor Relationship

Automated 32×32 Epitope Binning in a Single Assay

Rapid Discovery and Characterization of Monoclonal Antibodies Against the SARS-CoV-2 Delta Spike Protein

Your Ultimate Guide to CMC Testing Support for Gene and Cell Therapy

Cell Harvesting & Washing: Optimizing Viability and Recovery in Cell Therapy

Addressing the Gassing Rate in Bioreactor Upscaling – is vvm a Reliable Parameter?

Integrated Solutions for Advanced Therapies

mRNA Process and Cost Modeling: A Tool to Optimize Process Development

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Manufacturing

eBook: Working Together Is Key to Bioprocess Sustainability

Addressing Gaps in US Biomanufacturing Capacity

See all in Manufacturing

Analytical

Pharmaceutical Manufacturing Quality Assurance Programs: Transitioning from Research and Development to the Clinic

Process Validation: Calculating the Necessary Number of Process Performance Qualification Runs

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

Development of an IEX Purification Process for Lentiviral Vectors

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

Advanced Orthogonal Methods to Fully Characterize Process Host Cell Proteins

ELEVECTATM — Truly Stable and Inducible Producer Cell Line for Large Scale AAV Manufacturing

Advances in Bioanalytical Tools for the Characterization of In-Process Viral Samples

MAb Purification Process Development Using Mixed-Mode Resins — The DOE Approach

New Generation Planova™ S20N Demonstrates Robust Performance for Multi-Specific Antibodies

Advantages of Mixed-Mode Chromatography in Host Cell Protein Removal

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  • BioProcess International Academy
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