Tuesday June 23, 2020
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  • 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
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    • Economics
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    • Pre-Clinical and Clinical Trials
    • Regulatory Affairs
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人体艺术套图

Scalable Manufacturing of Lentiviral Gene Therapies

Lentiviral vectors are excellent candidates for introducing ex vivo gene therapies to patients who have lysosomal storage diseases.

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COVID-19 pipeline: Industry flexing its Abs in fight against coronavirus

From Regeneron to GSK, monoclonal to bispecific, industry is increasingly looking at antibody (Ab) therapies to tackle the novel coronavirus.

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A Future-Proof Solution for Bioprocess Applications: The New Eppendorf Flexible Bioreactor Control System Evolves with the Changing Needs of Modern Biotechnology

SponsoredEppendorf presents the SciVario twin bioreactor controller, a modular system designed to adapt to the changing needs of bioprocess operators.

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eBook: Sensor Technologies — Essential Tools for Bioprocessing 4.0

The biopharmaceutical industry sorely needs robust single-use and smart sensors for bioprocess monitoring as it approaches automation and digitalization.

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Implementation of Single-Use Miniature Bioreactors to Support Intensified Cell Culture: Using Functional Performance Indicators to Assess a Small?Scale Model

SponsoredSartorius ambr minibioreactors mimic benchtop reactors for batch and fed-batch cell culture, expediting biologics development and diminishing cost of goods.

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A Response Plan for Viral Contamination in Bioproduction Facilities

Biopharmaceutical companies should invest beyond standard preventive measures to develop appropriate response plans for viral contamination events.

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Commercialization Frameworks for the Biopharma Ecosystem

SponsoredIn this CPhI Theater presentation, delivered on 4 June 2019, Kiran Chin (managing partner and chief executive officer at MKA Insights) brings to the fore key questions and commercialization frameworks for biopharma start-ups.

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Using Blockchain Technology to Ensure Data Integrity: Applying Hyperledger Fabric to Biomanufacturing

Using blockchain technologies such as Hyperledger Fabric in biomanufacturing can ensure the integrity of data gathered during bioprocessing.

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Ask the Expert Webcasts

On-Demand Webcasts

  • Assembly, Labeling, and Packaging Trends: Next Decade’s Sterile Finished Goods Solutions
  • Identification of Host Cell Protein (HCP) Impurities using Antibody Affinity Extraction and Mass Spectrometry Approach

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BioProcess Insider News and Analysis

@bioprocessintl Tweets

  • Tweet Avatar@BPI_TechEditor gets the #downstream perspective on #speedtoIND from Margit Holzer of Ulysse Consult. Learn more ab… https://t.co/9bp3PtZgnY4 hours ago
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  • Tweet Avatar@BPI_TechEditor interviews Yuval Shimoni of @BayerPharma to learn how #singleuse and #automation can help biopharma… https://t.co/TfpkSt7hVX4 days ago
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Upstream Processing

Application of Targeted Locus Amplification for Enhanced Apollo X CHO Clone Screening

The Upstream Perspective: Taking Efficiency Beyond Cell-Line Development

See all in Upstream Processing

Downstream Processing

The Downstream Perspective: Putting Product Knowledge to Work Using Technological Innovations

Discover, Develop, Deliver

See all in Downstream Processing

White Papers

Writing the Future of Biologics to Discover and Optimize Antibodies

Confidence in Host Cell Protein (HCP) Coverage Assays with Differential Gel Approaches

Why, Why, Why… ELISA? A Look at the Benchmark HCP Assay

Cyclic Cell Harvest with CONTIBAC® SU Filters

Challenges Of Host Cell Protein Analysis With ELISA And How To Obtain Better Coverage Of Your ELISA Antibody Reagents

Effectively Securing Cell and Gene Therapies with Closed Systems

Understanding and Controlling Raw Materials Variation in Cell Culture Media

Why Characterizing Protein Stability Matters For Drug Development

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Manufacturing

The Green Imperative: Part One — Life-Cycle Assessment and Sustainability for Single-Use Technologies in the Biopharmaceutical Industry

Applications of Disposable Technologies for Upstream Bioprocessing

See all in Manufacturing

Analytical

The Analytical Perspective: Turning Data Into Information Requires Teamwork

Trends in COVID-19 Diagnostic Test Development

See all in Analytical

Posters

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

New Approach for Qualifying Liquid Handling in Single-Use Bags

Antibody Affinity Extraction Enables Identification of Host Cell Proteins by Mass Spectrometry

Step-wise strategy to address process characterization and late phase development – toward the definition of a standardized approach

Characterization and Lot Release Assays for Antibody Drug Conjugates

Keeping Host Cell Protein ELISAs Covered

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Webinars

Relative and Absolute Quantitation of Impurities and HCPs Using Mass Spectrometry

2.5× Lentiviral Vector Bioreactor Yield Increase and Simplified Execution with Innovative Tangential-Flow Depth Filtration

Optimizing Your Excipient Screening for Vaccine Formulation with an Ultra-Pure Pharmaceutical Gelatin

Protein A Chromatography: Using Automation Instead of Multiple Columns To Increase Productivity

Technology-Ready Processes for Gene Therapy Manufacturing 2.0

Innovative Closed Process CAR-T Cell Therapy Platform to Streamline Approach for Manufacturing with Great Predictability

Assessing Viral Clearance in Early Phase Process Development

Accelerating Vaccine Development By Innovative Purification Solutions and State of the Art Quality Testing

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Trending

  • Business

    Biosimilars Pipeline and Market Trends

  • Manufacturing

    Managing Risk in Single-Use Systems Design and Implementation: A Shared Responsibility

  • Analytical

    Trends in COVID-19 Diagnostic Test Development

  • Upstream Processing

    Retrofitting Your Bioreactor to Enhance Stirring Processes: Replacing Old Agitators with State-of-the-Art Magnetic Mixing Technology

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人体艺术套图