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Panelists

Victoria Hepworth

Product Manager
Greenfield Global

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Panelist

Victoria Hepworth

With over a decade of hands-on experience in the biopharmaceutical industry, Victoria specializes in the design and implementation of ready-to-use solutions and single-use consumables supporting downstream purification processes. She brings a strategic, highly collaborative approach to problem-solving, partnering closely with cross-functional teams to deliver scalable improvements that enhance operational efficiency and drive successful results.

Victoria is passionate about building strong team environments, supporting diverse learning styles, and applying data-driven decision-making to optimize performance across the process lifecycle.

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Cole Cordes

Head of Manufacturing,
Supply Chain and MSAT
Bionova Scientific

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Panelist

Cole Cordes

With more than 30 years of leadership experience in the biopharmaceutical and life sciences industries, Cole specializes in manufacturing operations, supply chain strategy, and MSAT across the product lifecycle. He brings a strategic, results-driven approach to operational excellence, partnering with cross-functional teams to optimize manufacturing performance, strengthen supply reliability, and support successful commercialization.

Cole is passionate about building high-performing organizations, developing talent, and leveraging data-driven decision-making to drive continuous improvement, scalability, and business growth.

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• Time: 08:00 PDT, 11:00 EDT, 17:00 CET

Downstream bottlenecks often stem from early process design decisions that fail to fully account for scale, variability, and the manufacturing realities of therapeutic modalities such as monoclonal antibodies.

As upstream titers rise and novel modalities introduce added complexity, these early oversights can force reactive workarounds that impact throughput, cost, and product quality. By taking a more deliberate and forward-looking approach, teams can reduce downstream risk and build processes that are better equipped for manufacturing scale.

In this GEN webinar, our speakers will examine five common planning gaps that can contribute to bottlenecks, including single-source material dependency, raw material pack size selection, sensitive buffer designs, and single-use systems designed without realistic failure modes. Using real-world MSAT and tech transfer examples, they will illustrate how, when overlooked, these drivers can lead to deviations, safety risks, and longer cycle times—and how to proactively address them. The webinar explores practical strategies that can help evaluate materials, buffer systems, and consumables through a scale‑ready lens—helping teams build more robust purification processes and avoid these common bottlenecks.

A live Q&A session will follow the presentation offering you a chance to pose questions to our expert panelists.

Produced with support from:

The post When Process Design Fails: 5 Common Planning Gaps That Create Downstream Purification Bottlenecks appeared first on GEN – Genetic Engineering and Biotechnology News.

Flu shots reduce hospitalizations and deaths for the roughly one billion people worldwide that get the flu each year. But they are less effective when the vaccine strains don’t closely match the viruses circulating in the community. Today’s vaccines are made months in advance of the flu season due to a long manufacturing process. When projections are off, strain mismatch can reduce the efficacy of the flu vaccines from about 60% (in a good year) down to 19%. A broader immune response could translate to a more effective vaccine even when the virus is changing faster than vaccine makers can update their shots.

Now, an investigational mRNA influenza vaccine, developed by Moderna, helps the immune system recognize a wider range of influenza viruses than today’s standard flu shot, offering stronger and potentially longer-lasting protection. The vaccine is currently under review by the U.S. Food and Drug Administration and, if approved, would be the first mRNA vaccine against influenza.

The findings are published in Nature Immunology in the paper, “mRNA-based influenza vaccine expands the breadth of the B cell response in humans.”

“We are seeing that the mRNA flu vaccine doesn’t just boost the immune system’s response to what it has already seen, it can help expand and diversify the antibody response, covering a broader range of flu strains,” said Ali Ellebedy, PhD, professor in the department of pathology and immunology at WashU Medicine. “If we can make flu immunity broader and more durable, that could mean fewer hospitalizations and deaths, which translates into a major impact on public health.”

In a separate Phase III clinical trial, Moderna found that its mRNA-based flu vaccine reduced the risk of illness by 26.6% more than the standard flu vaccine in older adults. Seeking to understand possible causes of this improved protection, the new study examined how immune responses to the mRNA-based flu vaccine differ from those of the standard vaccine.

The researchers followed 75 adults ages 20 to 50 over either the 2022-2023 flu season or the 2023-2024 flu season. About half received the investigational mRNA vaccine (mRNA-1010). The other half got Fluarix, an approved flu shot containing inactivated influenza viruses. Both vaccine platforms targeted the same strains recommended by the World Health Organization for the two flu seasons.

Analyzing blood samples, the researchers found a stronger immune response in participants who received the mRNA vaccine compared with participants who received the standard flu shot. Specifically, those given the mRNA vaccine produced more flu-specific antibodies and more flu-specific memory B cells.

“Influenza is constantly evolving to evade our immune system,” said Hanover Matz, PhD, a postdoctoral research associate working in Ellebedy’s laboratory. “But if we can develop vaccines that activate diverse B cells that target a broad portfolio of flu viruses, we have a better chance of avoiding strain mismatches and potentially even reducing the frequency with which the vaccine is needed.”

To investigate the vaccine’s ability to diversify B cells, the researchers studied germinal centers—where B cells improve their ability to recognize the virus and generate slightly different versions of themselves—in a subset of participants. It had not been previously understood if mRNA-based influenza virus vaccines can induce a superior germinal center (GC) response.

Among 13 people receiving the mRNA flu vaccine, five developed flu-specific germinal center responses in the lymph nodes that persisted for the 26 weeks of the study. In contrast, persistent immune responses were not seen in the 15 participants who received the traditional flu shot.

In addition, from four weeks after vaccination until the six-month mark, antibodies from mRNA vaccine recipients recognized and bound to many diverse flu strains across many decades of viral evolution, especially those known to cause the most widespread illness. Antibodies from standard vaccine recipients bound to fewer divergent virus strains.

These findings, the authors note, reveal a key role for persistent GC responses in broadening the repertoire of vaccine-induced antibodies. “We are seeing that the mRNA flu vaccine is driving strong, persistent germinal center responses,” said Ellebedy. “This can broaden the antibody response and better arm the immune system against an ever-changing virus.”

The post mRNA Flu Vaccine Shows Stronger, Longer-Lasting Immune Response appeared first on GEN – Genetic Engineering and Biotechnology News.

Officials at Leiden, Netherlands-based CRO ZoBio say the company has launched a DNA-Encoded Library (DEL) discovery service, which is designed to help biotech and pharmaceutical companies generate validated, progressible hits against novel and challenging drug targets.

The new offering combines structure-grade protein production, quantitative biophysics, DEL screening, off-DNA hit validation and X-ray crystallography into a single workflow, according to a company spokesperson, who explains that it enables clients to move beyond hit identification toward high-confidence starting points for drug discovery programs.

ZoBio maintains that unlike transactional DEL screening approaches that focus solely on hit generation, its platform is designed to deliver biologically relevant, structurally characterized hit matter with clear potential for progression. The service is particularly suited to exploratory and difficult-to-drug targets, including protein–protein interactions (PPIs) and targets with poorly defined binding pockets, where conventional screening approaches often fail, notes Gregg Siegal, CEO of ZoBio.

“Drug discovery teams today are increasingly focused on highly validated but technically challenging targets, where traditional screening approaches can struggle to deliver meaningful starting points,” he continues. “Our approach combines DEL technology with the structural biology, biophysics, and assay expertise needed to generate hits that clients can confidently progress.”

Siegal also points out that the DEL service is library-agnostic, enabling clients to access commercially available DEL collections or apply ZoBio’s workflow to proprietary client-owned libraries. The integrated platform reportedly includes:

• Structure-grade protein production and characterization
• Quantitative biophysical assay development using techniques such as SPR
• Biophysically informed DEL selection design
• Interactive DEL data analysis and hit prioritization
• Off-DNA hit resynthesis and orthogonal validation
• Structural characterization through X-ray crystallography
• Mechanistic insight to support downstream optimization

The workflow is designed to support collaborative decision-making throughout the discovery process, helping clients rapidly establish whether difficult or exploratory targets are viable for further development, according to Siegal, who says that members of the ZoBio team will be available for meetings during the BIO International Convention in San Diego to discuss the new service.

The post ZoBio Introduces DNA-Encoded Library Service for Exploratory Drug Discovery Programs appeared first on GEN – Genetic Engineering and Biotechnology News.