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- FDA Releases Draft Guidance To Accelerate Biosimilar Development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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![GettyImages-2181060355-laptop-hand-check-mark-digital-validation]( "The GxP Digital Maturity Model")
The GxP Digital Maturity ModelExplore how the GMP Digital Maturity Model guides life sciences companies through five stages to improve compliance, efficiency, and profitability with strategic digital adoption.
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Accelerating The Development And Production Of High-Quality bsAbs3/7/2024
Bispecific antibodies (bsAbs) are revolutionizing medicine by targeting two disease mechanisms simultaneously. Learn about an innovative platform offering excellent pairing and enhanced productivity.
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Tech Transfer At Risk: The Imperative For Digital Maturity, Modernization12/2/2024
Tech transfer is critical for biopharmaceutical production, but outdated tools can hinder the process. Discover how digital maturity can streamline operations, reduce risks, and accelerate time to market.
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Mitigating Early Development Risks9/11/2024
Discover how the efficient screening of biologic candidates accelerates the discovery process, reduces costs, and improves the likelihood of commercializing safe and effective drugs.
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Calculating The ROI Of EAM/CMMS For Pharma Manufacturers And CDMOs10/6/2025
Learn how modern EAM and CMMS systems help pharma manufacturers reduce risk, improve compliance, and cut costs, as well as nine signs it’s time to move beyond outdated asset management practices.
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Bench To Bedside: Trends In Regenerative Medicine7/19/2024
Discover the promising capabilities of regenerative medicine. Learn about four advanced techniques that can restore damaged tissue and offer hope to patients with severe conditions.
BIOPROCESSING APP NOTES & CASE STUDIES
- 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
- 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
- Driving Sustainability In Bioprocessing With Biobased Single-Use Solutions
INDUSTRY NEWS
NEWSLETTER ARCHIVE
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