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Software Can Solve CGT’s Sectors Traceability Challenges

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The most important role of industrial software for the cell and gene therapy sector is the ability to precisely trace materials from collection site through the plant and back to the patient. So says Jonathan Wofford, CCO at Phoenix, Arizona software developer, Title21 Health Solutions, who told GEN, “CGT manufacturing typically involves fragmented, bespoke workflows.

“The complexity is compounded by several variables, including diverse collection methods and protocols, highly variable starting materials, operator techniques, and challenging logistics. Therapies are time-sensitive and orchestration between collection centers, manufacturing facilities, and treatment centers is critical.

“As a result, CGT manufacturing requires coordination across a complex ecosystem that includes clinical operations, manufacturing, supply chain, quality, and data management, unlike mature and standardized mAb production processes.”

And this is where software makes its biggest, if somewhat underacknowledged, impact, according to Wofford.

“The primary value of software systems is not replacing or automating manufacturing processes, but rather bringing control, standardization, and traceability of manual data workflows,” he pointed out. “CGT manufacturing is variable and typically involves multiple changes in custody…each handoff creates opportunities for human error, documentation discrepancies, and compliance risk.”

Traceability in the plant

Software can also enhance the traceability of data within the manufacturing facility.

“Software platforms can help bring quality control and standardization to data entry and workflow management manufacturing through multiple features,” he continued, using electronic batch records as an example. “Industrial software system can also facilitate real-time chain-of-identity and chain-of-custody tracking, with live dashboards and analytics capabilities to drive enhanced insights into production runs, as well as real-time automated warnings for in-process issues or data values.”

The ability to trace materials and data in the plant is always going to be important, even if technology advances allow CGT process developers reduce the requirement for manual handling.

“Adoption of closed-system manufacturing may increase over time. However, today, software systems remain a more immediate solution for improving data accuracy, reducing manual data entry and processes, strengthening compliance controls, and driving analytics,” said Wofford, noting that this is where the emerging cell and gene therapy industry should focus its efforts rather than on promising yet untested technologies like artificial intelligence (AI) based process control systems.

“CGT organizations should be prioritizing technologies that can deliver meaningful and measurable operational and compliance benefits now,” he emphasized. “In the not-too-distant future, AI will likely contribute to predictive manufacturing and autonomous process control. But the greatest value today lies in targeted applications that improve efficiency, strengthen compliance, accelerate batch reviews, and generate actionable insights from complex data.”

The post Software Can Solve CGT’s Sectors Traceability Challenges appeared first on GEN – Genetic Engineering and Biotechnology News.

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New webinar: Tackling drug discovery challenges in cancer research

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Cancer cells

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.

Register for free now.

The post New webinar: Tackling drug discovery challenges in cancer research appeared first on Drug Discovery World (DDW).

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Psilocybin proves promising in neuropathic pain mouse study

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Amid the rise of psychedelics in the mental health space, researchers have begun to explore psilocybin as a treatment for chemotherapy-induced peripheral neuropathy.

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New Spectrometry Technique Could Aid Formulation Development

New Spectrometry Technique Could Aid Formulation Development

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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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