Uncategorized
When Process Design Fails: 5 Common Planning Gaps That Create Downstream Purification Bottlenecks
Panelists
Victoria Hepworth
Product Manager
Greenfield Global
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.
Cole Cordes
Head of Manufacturing,
Supply Chain and MSAT
Bionova Scientific
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.
- Time:
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.
Uncategorized
New webinar: Tackling drug discovery challenges in cancer research

Hosted by Drug Discovery World and supported by Sartorius and BioIVT, this webinar will explore the opportunities and challenges that exist within cancer research drug discovery and development.
You will hear from Dr Sudha Rao, Chief Scientific Officer of Kazia Therapeutics, Karol Budzik, PhD, Business Development Associate at Vyriad Therapeutics and Lars van der Veen, Chief Scientific Officer at iOnctura.
Presentations will cover how cancer treatments have shifted towards reprogramming the biology driving tumour growth, immune escape and treatment resistance, the trajectory that in vivo CAR-T treatments are taking, and how challenging tumours burdened by stroma and immune-mediated resistance can be tackled.
Q&A with the speakers follows the presentations.
The post New webinar: Tackling drug discovery challenges in cancer research appeared first on Drug Discovery World (DDW).
Uncategorized
Psilocybin proves promising in neuropathic pain mouse study
Amid the rise of psychedelics in the mental health space, researchers have begun to explore psilocybin as a treatment for chemotherapy-induced peripheral neuropathy.
Uncategorized
New Spectrometry Technique Could Aid Formulation Development
New Spectrometry Technique Could Aid Formulation Development
A new technique combining two forms of spectrometry could help biopharmaceutical companies improve their choice of formulation buffer for antibody manufacturing by revealing how molecular forms and three-dimensional shapes of complex biologics respond to their environment. That’s the view of Christian Bleiholder, PhD, a professor at Florida State University who helped develop the technique.
According to Bleiholder, what happens structurally when a complex biological molecule, such as an antibody or viral spike protein, binds to its target is currently poorly understood.
“This is where [this approach] can help with the bioprocessing and formulation,” he says, as structural changes “can affect the lifespan [of the product] and lead to issues, such as aggregation.”
Because antibodies are complex, existing techniques tend to be powerful at different levels of complexity, he explains. Mass spectrometry is particularly powerful for distinguishing molecular composition, while structural approaches such as X-ray crystallography and cryo-electron microscopy can provide high-resolution structural information.
The challenge is understanding the link between these things within a heterogeneous sample, he says.
To overcome this, Bleiholder and his team worked with Bruker Daltonics to develop Tandem-Trapped Ion Mobility Spectrometry (Tandem-TIMS). This combines tandem ion mobility spectrometry with tandem mass spectrometry to disentangle three overlapping layers of molecular complexity: molecular form, three-dimensional shape, and binding or assembly state, he says.
He explains that, if the proteins have different structures, they can be characterized with tandem ion mobility spectrometry, and then mass spectrometry can be used to look at their molecular forms and binding states.
Going forward, Bleiholder hopes the technique can be used for formulation development but also earlier, during drug discovery of new products, such as multi-specific antibodies, to determine which molecular states are important and how those change when a biologic engages its target. He also plans to look at automating the technique.
Bleiholder spoke about using Tandem-TIMS at the Bioprocessing Summit in Boston earlier this year.
The post New Spectrometry Technique Could Aid Formulation Development appeared first on GEN – Genetic Engineering and Biotechnology News.
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