Gail Dutton
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I cover life sciences, technology and policy. I also have covered training and logistics earlier in my career.
Dutton is a journalist, writing for GEN, Leaps, LabManager, Training and other publications.
Articles by Gail Dutton
Overcoming Bottlenecks: Biopharma’s Big Challenge Is Execution
Home > Topics > Bioprocessing > Overcoming Bottlenecks: Biopharma’s Big Challenge Is Execution Credit: Extreme Media/Getty Images The biggest challenge facing the biopharma industry isn’t scientific innovation. It’s manufacturing execution. That’s the opinion of Nicolas Pivet, vice president and general manager of manufacturing and digital solutions at Cytiva.
Trends in NGS
Next-generation sequencing (NGS) has matured into an essential part of modern drug development and diagnostic laboratories, and its steadily dropping costs are making it affordable for many facilities that a few years ago couldn’t justify the expense. The coming years will build on that foundation by extracting more and different types of data from samples, leveraging AI both upstream and downstream, and streamlining workflow.
Big Data Opportunities in Biomanufacturing
Is your data a predictive asset or something that merely takes up storage space? Odds are good the answer is the latter. Yet, data sets from R&D, tech transfer, facilities operations, supply chain operations, and quality optimization hold details that could be predictive assets for current and future biomanufacturing, product development, and supply chain operations.
Multi-Controller System: Major Boost to Continuous CHO Perfusion
A nonlinear model predictive control system developed by researchers at Sartorius is making fully-continuous biomanufacturing for Chinese hamster ovary (CHO) cells more productive. By simultaneously controlling feed, bleed, and harvest flows, they increased production by 68% and maintained viable cell density at or above 95%.
Choice of Excipients Dramatically Affects Antibody Solubility
The excipients added to therapeutic protein formulations are more specific than biomanufacturers typically realize. As it turns out, these inactive ingredients have markedly different effects on solubility, and those differences are based on certain specific physicochemical factors.
Increasing CHO Cell Productivity
Overexpressing the cytoplasmic poly(A)-binding protein gene Pabpc1 increases protein titers in Chinese hamster ovary (CHO) cell lines by 30–50%, according to researchers from BeOne Medicines (formerly BeiGene). Those results, published in a recent paper, appear consistent across multispecific and monoclonal antibodies.
Bicistornic Vectors + piggyBac = Improved Antibody Cell Line Production
Home Topics Bioprocessing Bicistornic Vectors + piggyBac = Improved Antibody Cell Line Production Credit: JUAN GAERTNER/SCIENCE PHOTO LIBRARY/ Getty Images To produce stable cell lines for monoclonal antibody production, manufacturers typically use the piggyBac transposon system. For larger, multi-specific antibodies that have payloads of three or four cistrons (sections of genes that express one complete, functional polypeptide), piggyBac is only the starting point.
Affordable Bioreactor Helps Prep Students for Biomanufacturing Careers
Home Topics Bioprocessing Affordable Bioreactor Helps Prep Students for Biomanufacturing Careers Credit: Benjamin Toth/Getty Images The biomanufacturing workforce of the future is hampered by a lack of familiarity with the technology today. Consequently, when those students choose careers, biotech isn’t top of mind and, even when it is, they may not have developed the deep understanding to help them succeed in biomanufacturing careers.
Protecting Scientific Intent in AI-Enabled Labs by Not Letting AI Set the Mission
Home Topics Artificial Intelligence Protecting Scientific Intent in AI-Enabled Labs by Not Letting AI Set the... Forget self-driving labs. For scientific AI to thrive, humans must always be in charge, setting objectives, constraints, risks, and interpreting results. [Maite Mueller/Getty Images] AI is neither saint nor demon. Nor should it be a replacement for human scientists.
SFA Spectroscopy Chases Away Cloudy Samples
Share Facebook Twitter Linkedin ReddIt Email Brendan Darby, PhD Co-founder and CEO Marama Labs Characterizing the RNA and ligands in nanoparticle-based therapeutics has, historically, been a cumbersome process. The lipid nanoparticles (LNPs) that encase RNA and payloads are cloudy by nature, which means analysis can’t be accomplished using the UV/Vis spectrometers that are ubiquitous throughout the life sciences industry.
Five Steps to Enable Self-Optimizing Process Purification
Home Topics Bioprocessing Five Steps to Enable Self-Optimizing Process Purification Two women wearing safety workwear seen in a pharmaceutical laboratory in front of the complex machine that is the part of drug manufacturing. Self-optimization is the next evolutionary step for bioprocessing purification systems and, although that step is near, it currently is hindered by missing integrations among its many parts and by loose usage of precise concepts.
AI “Council of Models” Improves Workflows and Outcomes
To maximize the benefits of AI, biopharmaceutical manufacturers need to take an end-to-end systems engineering approach to their data, preparing it for AI while orchestrating the right models for each stage of a workflow. Relying solely on a single foundation model is often insufficient, particularly as complexity increases and therapeutics advance from pilot stages into production. No single model excels at every task.
Downstream Purification Platform Breaks Complex Vector Bottleneck
Downstream processing is becoming a bottleneck as biopharmaceutical manufacturing shifts to more complex bispecific antibodies, FC-fusion proteins, and adeno-associated viral (AAV) vectors. A purification platform developed by a team of 24 researchers at North Carolina State University removes that bottleneck by providing both high flow-through and superior impurity capture.
Free-Floating Bioelectronic Sensors for Fermentation Monitoring
The static, mounted monitoring systems currently used inside fermentation vats are poised to be replaced in the near future with a network of free-floating bioelectronic sensors, if the vision of researchers from Boston University and Capra Biosciences reaches fruition.
Ag Genomics Begins to Bear Fruit
Agrigenomics is, to use an analogy, spring looking toward summer. Wielding modern genomics tools fine-tuned to agriculture, along with AI-driven insights from field technologies and satellites in low Earth orbit, traditional agriculture is transitioning to precision farming and the bounty it brings.
Issue No. 7, July 2026 Archives
Copyright © 2026 Sage Publications or its affiliates, licensors, or contributors. All rights reserved, including those for text and data mining and training of large language models, artificial intelligence technologies, or similar technologies.
Local PBMC Isolation Enables Four-Hour Processing in San Diego
Fast, local cryopreservation is a consistent bottleneck for autologous cell therapy developers, even in major cell and gene therapy hubs. For the peripheral blood mononuclear cells (PBMCs) that form the foundation of immunotherapies, vaccine development and autologous therapies, every hour between leukapheresis collection and cryopreservation can degrade cell viability and functional integrity.
Interface Mismatches Remain Key Barrier to Continuous Bioprocessing
Achieving end-to-end continuous bioprocessing without introducing surges and pooling remains a goal for biomanufacturers. As they transition from vat to hybrid or continuous processing, biomanufacturers optimize individual steps but often overlook their interfaces, creating an imbalance in the system. “The primary barrier to end-to-end continuous biomanufacturing is often not the lack of continuous unit operations themselves.
KLK1 Expands Possibilities to Restore Vascular Health
Home Topics Drug Discovery KLK1 Expands Possibilities to Restore Vascular Health DiaMedica’s DM199 restores normal levels of the KLK1 protein, thus improving blood circulation to the placenta, possibly and gaining precious time in utero for babies whose mothers are preeclampsic. [DiaMedica] Knowing that the protein tissue kallikrein-1 (KLK1) is effective in treating ischemic diseases is one thing. Manufacturing it as a recombinant protein has been quite another.
Blueprint to Fill the Manufacturing Talent Gap
As biopharmaceutical companies expand facilities and reshore some manufacturing operations, the industry faces a shortfall of trained workers for its manufacturing facilities. While the Bureau of Labor Statistics recently predicted some 19,000 jobs would be created, PhRMA last year predicted the creation of 100,000 new jobs. Both predictions leave a gap between those jobs and the trained workforce.
Novel Feeder Cell Line Dramatically Expands NK Cell Production
Allogeneic natural killer (NK) cells appear promising as an adoptive cell therapy (ACT) that targets cancer. They’re limited, however, by production methods that can’t readily produce these cells in therapeutically relevant quantities.
China Sets Framework for Advanced Therapeutic Development
Home Topics Drug Discovery China Sets Framework for Advanced Therapeutic Development Credit: Liu Liqun / Corbis Documentary / Getty Images China’s Order 818—Regulations on the Administration of Clinical Research and Clinical Translation and Application of Biomedical New Technologies—establishes a new commercialization pathway for cell and gene therapeutics, gene editing, and other advanced therapeutics.
Analytics Map Purification Optimization Tradeoffs
Speed or quality? When it comes to two-step chromatography purification, biopharmaceutical manufacturers want both, despite knowing, realistically, that each choice involves tradeoffs. With purity, stability, toxicity, processing times, and costs hanging in the balance, the key optimization questions, therefore, are which purification efforts deliver the greatest return and how they can be combined to achieve the ultimate, optimal balance.
Updated Amplification Tool Rapidly Detects Mycoplasma
Nucleic acid amplification techniques (NAAT) are recommended by pharmacopoeias in the United States, the EU, and Japan as an alternative to traditional culture and indicator cell methods used to detect Mycoplasma in biological products. Used for in-process controls and release testing, NAAT is an improvement over traditional methods that take up to 28 days, but attempts to balance broad species coverage and sensitivity favor one over the other.
Bioproduction Pivots from Centralized to Regional Support
The global biopharma industry is placing increasing importance on regional support rather than only centralized expertise to help complex programs advance. A key benefit is access to local expertise in or near their time zone. The localization movement “is part of a global shift [in which] companies are assessing how they balance cost, quality, and risks across regions rather than relying on any single market,” Jessay Devassy, PhD, global R&D director, Ecolab Life Sciences, tells GEN.
Turning the Patent Cliff into a Bioplant Opportunity
The 2030 patent cliff may either decimate revenue streams or provide an opportunity for innovation that can transform the biopharmaceutical industry. As it stands today, some 200 biopharmaceuticals are scheduled to go off patent during the next four years, representing approximately $300 billion in revenue. That revenue hit can be softened if biopharma manufacturers replace traditional mammalian expression systems with a Lemna plant-based system.
Open-Source Up- and Downstream Modeling in a Unified Environment
A broad European industry/academic consortium, Inno4Vac, has developed a robust, open-source modeling platform that unifies upstream and downstream models and predicts product stability, all within a single environment. Unlike many open-source modeling programs, this one, called CADET-Hub, doesn’t need mad programming skills to use.
Mixed-Reality Fermentation Simulator Preps Workforce
Hands-on biomanufacturing training is expensive, regardless of whether that training occurs in manufacturing facilities where training may take production units offline, or in community colleges and universities where the availability of equipment and consumables may limit training time. A mixed-reality fermentation training platform dubbed BioSuite Virtual solves much of that challenge.
Technique Yields Uniform, High-Quality, EVs at Scale
Mesenchymal stem cell-derived extracellular vesicles (MSC-EVs) play an outsized role in intracellular communications, influencing such functions as inflammation and tissue repair. With the possible applications of these small, membrane-bound particles growing, an efficient, cost-effective production method has been on drug manufacturers’ wish lists for some time.
Heavy-Chain BsAbs More Manufacturable than Light-Chains
Bispecific antibodies (BsAb) were first approved in 2014. Since then, a total of 19 have been approved globally, and approximately 250 BsAbs are being developed by some 180 companies, according to a report from Research and Markets. As this therapeutic class moves out of the lab and into clinical and commercial sectors, manufacturing may be its biggest challenge. These dual-targeting compounds are considered difficult to produce, especially at scale.
Conserved Protein May Transform Anti-Inflammatory Strategies
Inflammation is at the core of many diseases. Yet, although many therapeutics have been developed to treat inflammatory diseases, they typically are designed to suppress the immune system, which uses inflammation as a tool to fight infection. Often, this inflammatory process gets out of control. That is the case with acute respiratory distress syndrome (ARDS), a complex condition that currently lacks any effective, approved treatments.
Big Improvements for CGT Manufacturing as Development Scales Up
As cell and gene therapies (CGTs) move from the research stage to commercial applications, biomanufacturers are seeing that many of the production techniques they relied upon at lab scale are no longer their best options. Life sciences solutions providers are well aware of the challenge and are responding with innovations of their own.
Adaptive, Agent-Oriented Control for Biomanufacturing Systems
Agentic AI goes beyond predictive and generative AI and, in biomanufacturing, has the potential to enhance efficiency by integrating with existing manufacturing infrastructure such as IoT sensors, process information management systems, management execution systems, and even enterprise resource planning software. The challenge, however, is that industrial biomanufacturing processes are complex, demand resilience, and are tightly regulated.
Overcoming the VLP Purification Bottleneck
Virus-like particles (VLPs) are a popular platform for biomanufacturers because of their good biosafety profile, immunogenicity, and ease of engineering, although downstream purification remains bottlenecked.
iPSC-Based Manufacture vs. Autologous Model Production Costs Examined via Financial Analysis
Autologous and allogeneic cell therapies are establishing viable clinical pathways but cannot be manufactured cost-effectively at scale. Manufacturing natural killer (NK) cell therapies, and possibly T-cell therapies, using induced pluripotent stem cells (iPSCs) is understood to be significantly more cost-effective. Now those cost advantages have been quantified.
Plant Molecular Farming Comes of Age
Plant molecular farming (PMF) may seem like a bold option for companies accustomed to mammalian or microbial systems, but recent advances have transformed plant-based bioproduction into serious, scalable biomanufacturing platforms able to produce even complex biologics cost-effectively. “A major advantage is sustainability,” Marco P.C. Marques, PhD, associate professor, University College London (UCL), tells GEN.
AI In Silico Multi-Omics Technique Cuts Therapeutic Development Costs
Bringing a drug from discovery through clinical trials takes too long and is too expensive, with preclinical costs alone estimated at $15 to $100 million. Employing artificial intelligence (AI) early in the process can lower those costs dramatically. AI itself isn’t a panacea, though, Jayson Uffens, CTO and chairman of GATC Health, tells GEN. Instead, “Smart computing makes smart people smarter.
Peptonics Solves Cell Culture Defoaming Debacle
Advances in surfactants are preventing foaming and reducing shear in the mammalian cell cultures used to produce monoclonal antibodies and viral vectors. One of the newest, Peptonic ih-T1010 (the generic term for this family of peptide and peptoid mimetics of poloxamers), is emerging as a viable alternative to poloxamer surfactants.
The Three Pillars of Successful AI Deployments
Artificial intelligence and machine learning (AI/ML) are breakthrough tools in biopharmaceutical processing, but they are only as good as the dynamic processes they interact with. You know the “garbage-in, garbage out” adage, but manufacturers need to look beyond those obvious inputs and ensure the entire bioprocessing operation is designed for sustainable AI/ML applications within the regulatory framework.
Electrorheoimaging Helps Manage Droplet Viscosity in Real-time
A new technique combined with changes in material design is making reversible viscosity modulations possible, according to researchers from the University of Guelph in Ontario, Canada. By connecting electrorheological properties to microscopic behaviors, biopharmaceutical manufacturers can simultaneously view real-time changes in emulsion microstructures and measure viscosity.
Agentic AI Swarms Degrade Decision-Making
Agentic AI swarms are just as dysfunctional as human managers, recreating many of the inefficiencies AI aims to eliminate, according to a just-released report, The Organizational Physics of Multi-Agent AI. This doesn’t mean AI is inefficient, but that it is susceptible to the same flaws that affect human middle managers.
Cas-CLOVER Gene Editing for CHO Cells
Researchers at Sanofi report that cas-CLOVER (deactivated Cas9 fused to the C-terminus of Clostridium Clo051) gene editing has the potential to notably enhance recombinant protein production in Chinese hamster ovary (CHO) cells, potentially offering an alternative to CRISPR-Cas9 editing. “We were looking for a gene editing technology with freedom to operate that yielded the same benefits of a CRISPR-Cas9 system, such as ease and efficiency.
Fermenter-Extractor-Separator Mixes Uniformly and is Gentle on Cells
A combined fermenter-extractor-separator has been developed by researchers at Iowa State University. Because it uses the Taylor vortex design, it is gentler than traditional fermentation, extraction, and separation techniques, which makes it attractive for microbe production and other biotech applications. Called the Taylor Vortex Fermenter-Extractor-Separator, it is envisioned as a bioreactor for small volumes of value-added products and for process intensification.
Manipulating Microliter Droplets without Sticking by Particle Coating
The fluid-handling bioprocessing surfaces that successfully repel microliter droplets aren’t as effective for nano- and picoliter droplets. Because those smaller droplets are more sensitive to chemical and topological differences in the substrate, they are more likely to stick to the surfaces they contact, which poses a challenge as bioprocesses move to ever-smaller quantities of liquids. One potential solution is to coat surfaces with low-surface-energy particles.
High-Density Fed-Batch Optimization Cuts GLP-1 Bioproduction Costs
Researchers in India have developed a high-density fermentation strategy that significantly increases the yields of recombinant glucagon-like peptides-1 (GLP-1) in Escherichia coli. It may reduce upstream production costs by 20–30%. U.S. governmental policy changes are expected to lower GLP-1 costs to payers from their list prices of $1,000 or more per month to about $350 per month this year, and future products targeted at $149 per month.
PI3Kγ: A New Approach to Respiratory Relief
Home Topics Drug Discovery PI3Kγ: A New Approach to Respiratory Relief With a small in-house staff, Kither Biotech relies on collaborations and contracts to advance projects aimed at modulating cell signaling via the PI3Kγ pathway. [University of Turin] Recently approved therapies for cystic fibrosis and chronic obstructive pulmonary disease (COPD) have created significant improvements among patients, but full-capacity lung function remains elusive.
Biomanufacturing Framework for Scaling and In-Line Monitoring
A biomanufacturing framework addresses the challenges of scaleup and scaledown, enabling biomanufacturers to scale more quickly and efficiently, whether they’re going from bench- to pilot-scale, or enhancing legacy processes. Developed by North Carolina State University (NC State University) and BioMADE, “the framework uses a statistical model of bioprocesses at both the microbioreactor scale as well as pilot scale.
pH Denaturation of dsRNA for mRNA Purification
Double-stranded RNA (dsRNA) is a critical immunostimulatory impurity in mRNA production and poses a problem for the downstream purification methods vital to manufacturing mRNA vaccines and therapeutics. Scientists at Sartorius BIA Separations in Slovenia and Johannes Gutenberg University in Mainz, Germany, have a novel solution: pH denaturation of dsRNA.
Biosynthesis of Medicarpin in Engineered Yeast
Scientists in China have developed a way to synthesize medicarpin in yeast—specifically, Saccharomyces cerevisiae, also known as baker’s yeast. Like paclitaxel in the 1990s, this tumor-attacking substance has only limited natural quantities and is considered difficult to synthesize. Developing an efficient biosynthesis method, therefore, is a key step in making the production of this antitumor and antibacterial isoflavonoid efficient and sustainable.
Framework to Optimize Mammalian Cell Culture Media Blending
In biopharmaceutical manufacturing, optimizing chemically defined media (CDM) is critical for enhancing cell growth, productivity, and product quality in mammalian cell cultures. Traditional screening methods, such as one-factor-at-a-time or factorial designs, tend to be labor-intensive. Media blending offers a simpler alternative—creating concentration variations through liquid mixing of pre-existing “mother” media.
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