Newsletter | October 1, 2025

10.01.25 -- How End Users Can Drive Single-Use Harmonization

SPONSOR

Webinar: Cell Bank & Scale Up Strategies for MSC & Exosome Manufacturing

This webinar explores two key decisions affecting the manufacturability and long-term success of advanced therapies. RoosterBio experts will share strategies for reducing costs, risks, and timelines in GMP manufacturing through optimized cell banking. Attendees will learn about major risk areas, effective banking strategies, and scale-up techniques for MSC and exosome production to support clinical and commercial success. Register here.

FOCUS ON FILL-FINISH

How End Users Can Drive Single-Use Harmonization

Though progress has been made in supplier-created standards, broader harmonization is difficult to balance in a competitive supplier market. In this segment from the Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up,” the panelists encourage self-regulation for the industry. This bottom-up approach, where standardization begins with end users, will ultimately put competitive pressure on suppliers.

Risk Control | Bulk Filling Application

Learn about a bulk filling system that enables you to achieve risk control, accuracy, and superior product recovery in your fill and finish operations.

FILL-FINISH SOLUTIONS

Quality Used Process Equipment At Competitive Prices - Federal Equipment Company

SPONSOR

Webinar: Driving Operator Safety and Process Efficiency Through Innovative Prep and Column Changeover

Join Asahi Kasei Bioprocess for a webinar on transforming pharmaceutical production. Discover how safety and efficiency can be strategic levers for long-term success through smarter prep and column changeover workflows. Explore innovative solutions—THESYS® ACS Ergo, CURSIV® DAC Ergo, and SLURIPREP®—that simplify processes, reduce risk, and empower operators with ergonomic, human-centered design for greater productivity. Click here to learn more.

FOCUS ON DOWNSTREAM MANUFACTURING

Beyond Traditional Monoclonal Antibodies

New antibody formats present new purification challenges due to novel impurity profiles. New methods and media are required to ensure safe, effective, and scalable manufacturing of these biologics.

Increasing Biomanufacturing Downstream Process Efficiencies

Downstream processing can account for up to 80% of biopharmaceutical production costs. Optimizing this stage is crucial for resource management, product quality, and overall yield.

Best Practices In HCP Assay Qualification And Bridging To A New Assay

Explore a case study using a specific HCP immunoassay and advanced orthogonal Antibody Affinity Extraction and Mass Spectrometry methods for assay qualification.

Scaling Analysis Of Protein Capture Devices

Take an in-depth look at a capture device designed to scale consistently by residence time.

DOWNSTREAM MANUFACTURING SOLUTIONS

White Raven's Accelerated Path To GMP Certification - Cytiva

Multitools For Clarification And Harvest - CARR Biosystems

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