When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.
- Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs
- A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches
- Global Implications Of Zero Tariffs On Indian Pharma Exports To China
- Why Do So Few Cell Therapies Make The Leap From Lab To GMP?
- Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
- FDA Releases Draft Guidance To Accelerate Biosimilar Development
- The Transition To E-Labeling Is More Than Uploading PDFs
EDITOR'S DESK
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![Bio-Kat-Kozyrytska]( "On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration")
On The Ground At BPI: Kat Kozyrytska On Ethical AI And CollaborationAI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.
Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.
DeciBio partner Carl Schoellhammer, Ph.D., speaks on the record with Bioprocess Online's chief editor Tyler Menichiello at the 2025 BioProcess International conference in Boston.
Nobel laureate, David Baltimore passed away at 87 years old, on September 6, 2025. He was widely regarded as a scientific visionary who at just 37, co-discovered reverse transcriptase, an enzyme that flipped molecular biology on its head by showing that genetic information could flow from RNA back to DNA, not just the other way around.
During a Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up," panelists discuss a way forward for the industry to unlock the true flexibility and promise of single-use technology.
GUEST COLUMNISTS
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![Globe Direcrtion-GettyImages-483422997]( "Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs")
Guidelines For Defining A Control Strategy Framework For Accelerated mAb ProgramsThis article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process.
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![Paper minimal-GettyImages-1365826561]( "A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches")
A Multi-Omics Approach For Characterizing Clinical-Scale iPSC BatchesThe transition from 2D to 3D cell culture requires a combination of advanced analytical techniques, but aligning new methods with established principles can be challenging.
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![India and us flags-GettyImages-1089423548]( "Global Implications Of Zero Tariffs On Indian Pharma Exports To China")
Global Implications Of Zero Tariffs On Indian Pharma Exports To ChinaDiscover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.
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![Laboratory scientist, headache, frustration-GettyImages-1600719537]( "Why Do So Few Cell Therapies Make The Leap From Lab To GMP?")
Why Do So Few Cell Therapies Make The Leap From Lab To GMP?Among other reasons, academic centers have access to sophisticated technology. In contrast, manufacturing suites must use established, validated methods.
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![Earth Diverse unity-GettyImages-2189085103]( "Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots")
Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation LotsThe terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.
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![asian woman suspicious looking at phone-GettyImages-2200130927]( "The Transition To E-Labeling Is More Than Uploading PDFs")
The Transition To E-Labeling Is More Than Uploading PDFsDespite tight restrictions, patchwork regulations, and an unclear timeline, one researcher says we're heading toward fully-digitalized drug labels.
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![2 Scientists shaking hands-GettyImages-2194013620]( "Are You Still Evaluating CMOs When You Really Need A CDMO?")
Are You Still Evaluating CMOs When You Really Need A CDMO?Outsourcing adds capacity and specialized knowledge to your supply chain. But contractors come in several types. Here's how to pick the right one.
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![lightbulb, inspiration, bright idea-GettyImages-825526728]( "Here's A Thought: What If Gene Editing Didn't Use Bacterial Enzymes?")
Here's A Thought: What If Gene Editing Didn't Use Bacterial Enzymes?Citing the dismally few wins for CRISPR/Cas9 and other gene editing systems, one scientist proposes delivering zinc finger DNA-binding peptides using AAV6 vectors.
BIOPROCESSING WHITE PAPERS
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![Female scientist microscope-GettyImages-1453524892]( "Process Scale Column Packing Instructions")
Process Scale Column Packing InstructionsExplore a comprehensive guide to using DurA Cycle A50, a high-capacity, alkaline stable protein A affinity chromatography resin for the downstream processing of mAbs and recombinant proteins.
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A Checklist For Efficient And Reliable Gene Therapy Manufacturing6/3/2024
Gain insight into how to design and execute an efficient upstream AAV production process, and follow the checklist within to ensure all appropriate factors are considered at each phase of drug development.
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Handling Protocols: Key Considerations In The Highly Potent API Market5/12/2025
Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.
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Microbial Challenge In-Use Studies6/13/2024
Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.
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Navigating Digital Transformation For Pharmaceutical CDMOs10/31/2025
Discover how CDMOs can modernize operations, safeguard data integrity, and improve audit readiness with practical strategies for connecting systems and reducing validation burdens.
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Quality: The Link Between Platform, Processes, And Patients2/18/2025
Quality management in healthcare and life sciences is crucial for optimizing patient health. Learn how modern quality management systems optimize patient outcomes, enhance safety, and drive operational efficiency.
BIOPROCESSING APP NOTES & CASE STUDIES
- How A Global Pharma Manufacturer Reduced Line Stops And Increased OEE
- Accelerating Cold Chain Expansion: Responding To COVID-19 Challenges
- Ensuring Product Safety And Purity With Mycoplasma And Sterility Testing
- N-1 Perfusion High Inoculum Fed-Batch For Reduced COGS And Easy Retrofit
- Measuring Scanning Motion Flatness With AFM
- FDA Releases Draft Guidance To Accelerate Biosimilar Development
- Supporting The Next Generation Of ADCs
- AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing
- On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration
- On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing
- On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D.
- Single-Use Standardization Starts At Home
BIOPROCESS ONLINE CONTENT COLLECTIONS
This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Accelerating Early Phase Biologics From The Clinic To Commercialization
- Designing Viral Clearance Studies By Phase, Modality, And Regulation
- Manufacturing Of CAR-T Cells: Automation And Defined Culture Conditions
- Intensified Antibody Purification With Membrane Chromatography
- Boosting Vaccine Yields Through Smarter Cell Culture Media Optimization
INDUSTRY NEWS
NEWSLETTER ARCHIVE
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- 11.13.25 -- Take Strides Not Steps With Your Cell & Gene Therapy Manufacturing Process
- 11.13.25 -- AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing
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