Newsletter | November 5, 2025

11.05.25 -- Dual Membrane Preconditioning Can Improve Concentration, Cut HCPs

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Webinar: Driving Sustainability in Bioprocessing with Biobased Single-Use Solutions

Join this Thermo Fisher Scientific webinar to explore how biobased Thermo Scientific™ BioProcess Containers (BPCs) and cell culture systems help achieve measurable reductions in Scope 3 carbon emissions. Learn how adopting biobased single-use technologies delivers quantifiable sustainability gains, reduces CO₂ emissions comparable to removing gas-powered vehicles from the road, and supports global decarbonization goals through actionable strategies for greener bioprocessing practices. Click here to learn more.

FOCUS ON DOWNSTREAM MANUFACTURING

Dual Membrane Preconditioning Can Improve Concentration, Cut HCPs

Research from Penn State, the FDA, and Takeda shows how combination filtration and purification steps improve output and reduce impurities.

Virus Reduction And Impurity Removal

Examine a DOE-based study that reveals how buffer conditions impact virus and impurity clearance using a mixed-mode resin, as well as gain practical guidance for optimizing downstream purification.

Utilizing RVLP To Evaluate Viral Clearance For Multiple Modes Of Separation

This study demonstrates that Retrovirus-like particles (RVLPs) can be used to accurately assess viral clearance, providing a valuable tool for the development of biopharmaceutical manufacturing processes.

Overcoming Scale-Up Challenges In Viral Vector TFF

Discover how a tailored TFF solution delivers a scalable, high-yield process that integrates smoothly with existing infrastructure and maintains regulatory compliance.

Speed Your Science With Integrated, End-To-End Manufacturing

Explore how to simplify your downstream viral vector manufacturing with integrated, end-to-end strategies that reduce delays and accelerate your path to the clinic.

Scalability And Reproducibility Of The AAV9 Capture Step

Scaling gene therapies beyond rare diseases demands innovation. Discover a chromatography system that boosts efficiency, protects product integrity, and overcomes viral vector manufacturing challenges.

Building A Fully Single-Use Process With Protein A Membrane Devices

Explore results from a study demonstrating the capability of an intensified, single-use downstream process for a fed-batch cell culture harvest producing a representative mAb at an industrial scale.

DOWNSTREAM MANUFACTURING SOLUTIONS

Prepare For Successful Biomarker Profiling From Cell-Free DNA - QIAGEN

Redefine Your Oligonucleotide Manufacturing - Asahi Kasei Bioprocess

Productivity In mAb Capture - Cytiva

FOCUS ON FILL-FINISH

mRNA-LNPs For Vaccine And Gene Therapy Indications

mRNA-LNPs are unlocking new therapeutic directions in cancer, rare diseases, and personalized medicine through recent advances in molecular and nanoparticle engineering.

Factors To Consider While Selecting Stoppers For Lyophilized Vials

Ensure the success and stability of your lyophilized products by choosing the right container-closure system — explore your stopper options, here.

Top 3 Things Your Sterile Fill Finish Operator Wants You To Know

Sterile fill finish operations can be complex. Those on the floor handling these products every day answer the question, "What are the top things customers should consider when beginning this step?"

Thermal Stability Technology Selection Guide

Thermal stability testing is essential for biologics development to help ensure safety and efficacy. Learn how thermal data supports candidate selection, formulation, and storage decisions.

FILL-FINISH SOLUTIONS

De-Risk Container-Closure Selection With DeltaCube - West Pharmaceutical Services

Capacity Update January 2025: Fill/Finish - Alcami

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