Tuesday March 28, 2023
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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

Podcast: From platform to patient, CGTs must be more accessible

We sit down with Ori's CEO Jason Foster to discuss the company’s paperless platform journey to commercialization.

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eBook: mRNA — Negotiating New Manufacturing Hurdles

Biopharmaceutical companies must surmount new hurdles stemming from increased demand for commercial-scale mRNA manufacturing.

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The CRISPR Saga (So Far)

The provenance of eukaryotic CRISPR has not been settled for good by the Patent Trial and Appeal Board. There are four parties involved: CVC, Broad, ToolGen Inc. and Sigma-Aldrich Co.

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Optimizing Process Economics Across Modalities

Sponsored Polyplus offers a look at process economics optimization and the legacy of innovation that is evolving into new approaches.

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Cold Chain Excellence: Getting Control Over Freezing of Biologics

Sponsored This special report from Single Use Support GmbH discusses how single-use systems can provide solutions for controlling biologics freezing.

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Plant-Based Protein Expression: Emerging Systems Bring Viable Approaches to Biopharmaceutical Manufacturing

The application of plant-based expression systems to produce biopharmaceuticals for human and veterinary indications are proving to be safe for clinical use.

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Scaling AAV Production: Easing the Transition from Laboratory Scales to Commercial Manufacturing

Best practices for scaling AAV production comes from the importance of identifying and monitoring critical quality attributes (CQAs).

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The Impact of Protein Stability on Virus Filtration

Sponsored This special report on virus filtration by scientists at Pall Biotech includes discussion of minimizing protein aggregation through formulation and handling considerations.

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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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Bispecific Antibodies Conference

@bioprocessintl Tweets

  • Tweet Avatar This eBook covers the current state of #bioprocess #monitoring, while identifying areas in need of further investig… https://t.co/Lje5qIS6fC 11 hours ago
  • Tweet Avatar Take a look at this article from our March issue, "Learning Management: Evaluation of Retraining Risk at Indian Pha… https://t.co/6MhWyfQJ5r 12 hours ago
  • Tweet Avatar Please join us for a #BPIAskTheExpert on "MAb Purification Process Development Using Mixed-Mode Resins — The DOE Ap… https://t.co/lu4b0SW3iQ 13 hours ago
  • Tweet Avatar Take a look at this article from our latest Featured Report, "Introduction: Practicalities of Aseptic Processing fo… https://t.co/vonAJxO6ud 17 hours ago

Upstream Processing

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

Deciphering Nutritional Needs in Bioprocess Optimization: Targeted and Untargeted Metabolomics with Genome-Scale Modeling

See all in Upstream Processing

Downstream Processing

Purification of Hepatitis B Virus Surface Antigen for Vaccine Products: Impact of Ligand Density on HBsAg Purification By Immunoaffinity Chromatography

Production and Purification of Newcastle Disease Virus: A High-Yield Platform Process Based on a Novel Avian Cell Line and Monolith Chromatography

See all in Downstream Processing

White Papers

Critical Factors of Fill Finish Manufacturing for Large Molecules

Responding to a Changing Drug Product Global Supply Chain

Rapid and Efficient Measurement of Critical Quality Attributes and Parameters Using Octet® Bio-Layer Interferometry (BLI) Systems

Magnetic Agitators Score on Climate Friendliness

From Concept to Cure: Using AAV in Gene Therapy

Solving Cost and Supply Challenges in Biopharma Downstream Processing

Leading Biopharma Uses Linkit® AX: Here are the Results

Intensified Biomanufacturing: Achieving 3-4-Fold Higher Titers of mAbs Using Syngene’s Intensified Fed-Batch Process

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Manufacturing

Introduction: Practicalities of Aseptic Processing for Modern Biological Drug Products

Cryopreserving Hematopoietic Stem Cells — Part 2: Methods, Materials, and Operations

See all in Manufacturing

Analytical

A Case Study in Environmental Monitoring: Reviewing Incubation Times Upon Recovery of Microorganisms

Water-Proton Nuclear Magnetic Resonance Spectroscopy: Emerging Applications for Vaccine Quality Assessment

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

Advantages of Mixed-Mode Chromatography in Host Cell Protein Removal

Accelerating Antibody Characterization and AAV Analytics Using Next Gen Biolayer Interferometry (BLI)

Beyond Standard Protein A Resin: Establishment of an Improved DSP Affinity Platform Step for Monoclonal Antibodies

Enabling Faster Feed Strategy Optimization with Rapid Spent Media Analysis and Data Visualization Tools

Benefits of Real-Time Analytics to Overcome Common Cell Culture Challenges

Simplify Residual DNA Quantitation in Viral Vector Production With qPCR and dPCR Tools

Simple In-House Mycoplasma Testing Method for Regulatory Expectations and Rapid, Confident, and Actionable Results

The BARDA Industry Day Breakdown

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