Newsletter | June 11, 2025

06.11.25 -- Formulation Is Key For Y-mAbs' Self-Assembling Antibody

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Explore the latest biotech equipment and solutions — all online, wherever you are.

Don't miss the next Bio-Expo Live! This interactive, multi-day event is organized by stages of drug development and production, making it easy to find sessions tailored to your company's needs. Browse the full agenda and register for free to join the conversations most relevant to your work.

FOCUS ON FILL-FINISH

Formulation Is Key For Y-mAbs' Self-Assembling Antibody

The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.

Delays To Market In Generic Drug Manufacture Can Be Costly

Mitigate risk upfront to maximize significant first mover advantage over later drug entrants. Explore the untapped potential for injectable generic drug growth and three priorities for maximizing speed to market.

Navigating Your Holistic Approach To CCI For Biologic Drug Products

Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.

How To Reduce Five Key Risks In Fill And Finish

Common fill-finish risks include human error, process variability, contamination, product inconsistency, and more. Explore best-practice solutions for manufacturers looking to de-risk this process.

Innovations In CGT Processing

discover insights into how innovative connectors streamline workflows, save time, and enhance reliability in critical applications, ultimately supporting improved outcomes in cell and gene therapies.

FILL-FINISH SOLUTIONS

Capacity Update April 2025: Fill/Finish - Simtra BioPharma Solutions

Capacity Update January 2025: Fill/Finish - Lonza

Capacity Update October 2024: Fill/Finish - INCOG BioPharma Services

Plate Freeze-Thaw Unit Large Scale - Single Use Support

FOCUS ON DOWNSTREAM MANUFACTURING

Analytics And Cross-Functional Communication: Keys To Purifying Complex Molecules

This summary features key takeaways from the Bioprocess Online Live event, "Challenges And Considerations For Purifying Multispecific Molecules."

Purification Strategies For Multispecifics

In this segment from the Bioprocess Online Live event, “Challenges And Considerations For Purifying Multispecific Molecules,” our panelists Mark Fitchmun and Dr. Jian Ren debate the use of affinity resins compared to ion exchange and multimodal chromatography methods.

Strategies For Viral Inactivation And Filtration In Multispecifics

In this segment from the Bioprocess Online Live event, “Challenges And Considerations For Purifying Multispecific Molecules,” our panelists cover molecule sensitivity to low pH and the use of detergent-based viral inactivation, as well as evaluating the suitability of platform viral filters.

Addressing Manufacturability And Scalability Challenges In Multispecifics Purification

In this final segment from the Bioprocess Online Live event, “Challenges And Considerations For Purifying Multispecific Molecules,” our panelists answer some remaining audience questions relating to viral inactivation, affinity resins, precipitation steps in purification, and downstream scalability challenges.

Optimizing DSP: Faster Timelines, Lower Costs, And High-Quality Processes

The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.

Innovative Purification Solutions For Therapeutic Antibody Manufacturing

Discover cutting-edge antibody purification resins designed to tackle challenges in purifying novel therapeutic formats like bispecific antibodies and Fc-fusion proteins with high efficiency.

Single-Step Purification Of A 21-mer Oligonucleotide

Explore how the oligonucleotide therapeutics market is advancing with scalable solutions for high-purity purification, supporting global production of life-changing RNA therapies.

Alternative Two-Step Mixed-Mode Approach To A mAb Purification Process

Two post–Protein A capture two-step mAb processes were developed and compared to an archetypical three-step mAb purification process using two IEX steps after Protein A capture.

More Flexibility At Reduced Costs With Protein A Membrane Technology

It’s time to look at how new protein A technologies may replace resin-based methods and enable more productive and flexible purification.

DOWNSTREAM MANUFACTURING SOLUTIONS

Bio-Expo Live February 2025: Downstream Bioprocessing - CARR Biosystems

A Single-Use Chromatography System For Scale-Up And GMP Manufacturing - Cytiva

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