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Monoclonal Antibodies: Unlocking Cost and Efficiency Gains in Downstream Processing

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Kristina Pleitt

Senior Staff Scientist
Thermo Fisher Scientific

Panelist

Image of Kristina Pleitt

Kristina Pleitt

Kristina Pleitt is a senior staff scientist at Thermo Fisher Scientific with 15 years of experience in biopharmaceutical process development and manufacturing. Her expertise includes downstream process development, process scale-up, integrated continuous processing, and clinical and commercial production, with a particular focus on advancing intensified downstream strategies that improve process efficiency, performance, and manufacturability.


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Analytical developers and downstream scientists are under constant pressure to improve process efficiency while maintaining product quality for monoclonal antibodies (mAbs). Yet, many platform purification processes still leave untapped opportunities for optimization, cost reduction, and simplification.

In this webinar, our speaker will explore a series of practical, chromatography-focused strategies designed to enhance mAb purification performance while reducing cost of goods (COGs). Using real-world examples and process scenarios, attendees will gain insight into:

  • Identifying opportunities to simplify traditional mAb purification workflows
  • Improving Protein A performance and lifetime to drive cost savings
  • Enabling efficient two-step downstream processes through better impurity management
  • Addressing difficult HCP and aggregate clearance challenges with advanced polishing strategies

A live Q&A session will follow the presentation, offering you a chance to engage directly with our expert and discuss how these approaches can be applied to your own processes.

Produced with support from:

Thermo Fisher logo

The post Monoclonal Antibodies: Unlocking Cost and Efficiency Gains in Downstream Processing appeared first on GEN – Genetic Engineering and Biotechnology News.

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STAT+: Pharmalittle: We’re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and more

Top of the morning to you, and a fine one it is. Sunny skies and mild breezes are enveloping the Pharmalot campus once again. And to celebrate, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is Jack Daniel’s. Yes, this is a real thing. And remember, a prescription is not required. So no need to mess with rebates, coupons, or TrumpRx. Meanwhile, here are a few items of interest. Hope you have a smashing day and conquer the world. And of course, do stay in touch. We appreciate feedback, criticism and tips. …

Sanofi asked the U.S. Food and Drug Administration to pull its type 1 diabetes drug, teplizumab, out of FDA Commissioner Marty Makary’s new speedy review program, STAT reports. The move comes after acting Center for Drug Evaluation and Research Director Tracy Beth Høeg disagreed with a staff decision to approve the drug. The agency missed its April 21 goal date to deliver a decision to Sanofi. Such decisions are typically made by career scientists. It is rare for a center director to become involved in scientific review of a single drug, and particularly a political appointee like Høeg. Makary recently said that he stands behind review teams, and that “disaster” occurs whenever political leaders overrule scientific staff. 

An experimental drug from Revolution Medicines that nearly ​doubled survival time for patients with advanced pancreas cancer in clinical trials comes with a high rate ‌of mostly low-grade side effects, Reuters tells us. A report by researchers from a first-in-human trial of daraxonrasib is the first peer-reviewed paper to show safety data for what analysts say could become the next standard of care for previously treated metastatic pancreatic cancer. Among the 168 patients with previously treated pancreatic ductal adenocarcinoma who received daraxonrasib in the early trial, treatment-related adverse side effects ​of any grade occurred in 96%, while severe or life-threatening events were reported in 30%.

Continue to STAT+ to read the full story…

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Top of the morning to you, and a fine one it is. Sunny skies and mild breezes are enveloping the Pharmalot campus once again. And to celebrate, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is Jack Daniel’s. Yes, this is a real thing. And remember, a prescription is not required. So no need to mess with rebates, coupons, or TrumpRx. Meanwhile, here are a few items of interest. Hope you have a smashing day and conquer the world. And of course, do stay in touch. We appreciate feedback, criticism and tips. …

Sanofi asked the U.S. Food and Drug Administration to pull its type 1 diabetes drug, teplizumab, out of FDA Commissioner Marty Makary’s new speedy review program, STAT reports. The move comes after acting Center for Drug Evaluation and Research Director Tracy Beth Høeg disagreed with a staff decision to approve the drug. The agency missed its April 21 goal date to deliver a decision to Sanofi. Such decisions are typically made by career scientists. It is rare for a center director to become involved in scientific review of a single drug, and particularly a political appointee like Høeg. Makary recently said that he stands behind review teams, and that “disaster” occurs whenever political leaders overrule scientific staff. 

An experimental drug from Revolution Medicines that nearly ​doubled survival time for patients with advanced pancreas cancer in clinical trials comes with a high rate ‌of mostly low-grade side effects, Reuters tells us. A report by researchers from a first-in-human trial of daraxonrasib is the first peer-reviewed paper to show safety data for what analysts say could become the next standard of care for previously treated metastatic pancreatic cancer. Among the 168 patients with previously treated pancreatic ductal adenocarcinoma who received daraxonrasib in the early trial, treatment-related adverse side effects ​of any grade occurred in 96%, while severe or life-threatening events were reported in 30%.

Continue to STAT+ to read the full story…

Read More

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Entrada crashes as Duchenne therapy comes in ‘below expectations’ in early study

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Entrada Therapeutics saw a 2.36% dystrophin increase in patients treated with its oligonucleotide asset—a number that fell short of the company’s prior guidance of a double-digit improvement.

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Next Gen Leadership Awards Presented at the AGBT Agricultural Meeting

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Last month, the AGBT Agricultural Meeting was held in Phoenix, Arizona. The conference is focused on agricultural genomics—plant and animal genetics. During the meeting, the recipients of the 2026 Next Gen Leadership Awards were announced.

These awards recognize outstanding early-career scientists and graduate students whose work and potential are shaping the future of agricultural genomics, including advances in plant and animal genomics. Award recipients receive financial support to attend and present their research at the AGBT Agricultural Meeting, with opportunities to engage with leaders in the field and build connections across the genomics community.

“These awardees reflect the strength and diversity of emerging talent in agricultural genomics,” said Sarah Hearne, PhD, chief science and innovation officer at CIMMYT and co-chair of the AGBT Agriculture Scientific Organizing Committee. “AGBT Agriculture plays an important role in bringing these scientists into conversation with leaders across the field, helping accelerate the translation of genomics into practice.”

The awardees represent rising leaders in agricultural genomics, advancing research across genomic variability, genetic analysis, molecular diagnostics, pathogen surveillance, and quantitative trait genomics to improve crop performance, strengthen food safety, and advance sustainable agriculture.

“This award represents a transformative opportunity to grow as a scientist and contribute more effectively to innovation in animal breeding,” said Larissa Bordin Temp, a 2026 Next Gen Leadership Award recipient.

The 2026 AGBT Agricultural Meeting Next Gen Leadership awardees were:

  • Boris ME Alladassi, PhD: postdoctoral research associate at the University of Illinois Urbana-Champaign
    • Research focus: Connecting the evolutionary and statistical views of epistasis in quantitative trait genomics
  • Mythri Bikkasani: graduate student at Punjab Agricultural University, India
    • Research focus: Connecting the dots: from high-throughput feed phenotyping to genomic dissection of heterosis in maize
  • Larissa Bordin Temp: graduate student at São Paulo State University, Faculty of Agricultural and Veterinary Sciences
    • Research focus: Genomic evaluation of rump fat–adjusted residual feed intake in zebu cattle: implications for selection strategies
  • Lauren Johnson: graduate student at Gluck Equine Research Center, University of Kentucky
    • Research focus: Functional introgression within the horse mhc genes
  • Mehak Kapoor: graduate assistant at Iowa State University
    • Research focus: Cell-type resolved gene expression signatures to identify and predict persistent PRRSV infection
  • Pedro Nuñez Romano, PhD: postdoctoral researcher at Universitat Politècnica de València
    • Research focus: Integrating technology to refine the estimation of social genetic effects in pigs
  • Viona Osei: graduate student at Tuskegee University
    • Research focus: Exploiting genomic variability in Listeria for the development of molecular diagnostic markers
  • Kyungyong Seong, PhD: postdoctoral fellow at the University of California, Davis
    • Research focus: Resurrection of the plant immune receptor Sr50 to overcome pathogen immune evasion
  • Jade van Wijk: graduate student at Earlham Institute
    • Research focus: Using airborne DNA sequencing to monitor sporulation, infection and relative abundance of cereal rust fungi

The post Next Gen Leadership Awards Presented at the AGBT Agricultural Meeting appeared first on GEN – Genetic Engineering and Biotechnology News.

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