Newsletter | August 20, 2025

08.20.25 -- Developing An In Vivo CAR-T With Interius BioTherapeutics' Sianny Christanti And Babu Medi, Ph.D.

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Webcast: Enhancing Process Development with Viral Clearance

Viral clearance studies are essential for ensuring the safety of biopharmaceutical products and for preventing costly changes to the manufacturing process. In this webcast, explore the latest data on Nuvia™ wPrime 2A Media, a scalable, weak AEX-HIC mixed-mode resin. The study demonstrates its viral clearance capabilities using co-spiked MuLV and MVM viruses across multiple conditions, with no residual infectivity detected in the end products. Watch the webcast now.

FOCUS ON FILL/FINISH

Developing An In Vivo CAR-T With Interius BioTherapeutics' Sianny Christanti And Babu Medi, Ph.D.

 On this episode of Better Biopharma, Interius BioTherapeutics’ Sianny Christanti and Babu Medi, Ph.D., explain how the company is re-engineering a lentiviral vector to enable INT2104, its off-the-shelf, in vivo CAR T-cell therapy. They discuss the vector's design and its manufacturability, as well as the analytical and regulatory challenges of bringing this first-in-human therapy to the clinic.

Biophysical Tools For Biotherapeutic Development

Discover essential analytical techniques in biotherapeutics development, as well as explore ITC, DSC, and Rheology—powerful tools for understanding formulation, stability, and efficacy in drug development.

4 Mistakes You Must Avoid When Outsourcing Vial Fill-Finish

Any errors during the fill finish stage can delay clinical trials or even prevent meeting funding milestones. Be sure to avoid these four common pitfalls when outsourcing your fill-finish project.

A Robust Extractables Data Package Helps Drive Patient Safety

Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

FILL/FINISH SOLUTIONS

Bioprocess Powder Bags - Entegris, Inc.

Capacity Update January 2025: Fill/Finish - Alcami

Sterile Fill/Finish Services - Bora Pharmaceuticals

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Join Bioprocess Online Live on September 9 at 11am ET for a Q&A with CMC and MSAT experts about how companies can align their teams to overcome internal barriers and unlock the promise of PATs. Registration is free for this digital event.

FOCUS ON DOWNSTREAM MANUFACTURING

9 Essential Oligosynthesis Component Needs

Meeting the growing need for oligonucleotides means having the right tools. Learn about the nine indispensable components, such as synthesis columns and C&D systems, for your facility.

Modular Selectivity With A Multimodal Resin For High mAb Purity, Recovery

Learn how a scalable multimodal resin with adjustable selectivity was employed to design an efficient mAb purification process in a flow-through mode.

PUPSIT Without The Pain: Practical Solutions For Implementation

Explore the critical role of pre-use post-sterilization integrity testing in quality risk management, as well as learn about integrity testing, wetting procedures, and innovative filtration systems for effective implementation.

Obtain Proteins With Optimal Properties For Commercial Applications

Tap into the vast diversity and potential of proteins found in nature using a unique protein platform based on Machine Learning and Design of Experiment.

Solvent-Free Purification Of D84-mer Oligonucleotide

Discover a solvent-free process using resins that enable high-purity, scalable purification of long oligonucleotides, achieving more than 95% of full-length product purity.

DOWNSTREAM MANUFACTURING SOLUTIONS

Unlocking The Cold Chain Of Proteins - Single Use Support

Purolite AP+ Resin Platform: Advanced Purification To Improve Manufacturing Efficiencies - Ecolab, Purolite™ Resins

Aseptic Processing Isolator (Filling-Lyophilization) From Franz Ziel - Koerber Pharma

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