Newsletter | May 28, 2025

05.28.25 -- Using AI To Predict Multispecific Formulation Patterns

SPONSOR

Join us for our three-day process development virtual summit on 10-12 June, 2025.

From upstream to downstream for protein-based and gene therapy processes. Attend one session or all twenty. Click to explore the full agenda and register.

FOCUS ON FILL-FINISH

Using AI To Predict Multispecific Formulation Patterns

This emerging class brings substantial formulation challenges beyond those of traditional mAbs. Here’s a comprehensive look at the issues and some solutions.

Alternatives To Testing Sterility In Cell- And Tissue-Based Products

Testing depletes precious product, and regulators increasingly support using other methods if they're backed by robust validation data.

The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

FILL-FINISH SOLUTIONS

Create A Quick And Easy Closed Connection - CPC

Aseptic Fill & Filtration For Large Volumes - Single Use Support

SPONSOR

Webinar: Seals & Stability: Preventing Failures in Synthesis and Chromatography Columns

This webinar highlights the overlooked importance of seals and O-rings in oligonucleotide synthesis and chromatography. Chuck Haeger shares real-world cases showing how proper maintenance and skilled teams prevent failures. Attendees will learn strategies to boost column longevity, reduce risks, and ensure high-quality output—ultimately supporting the production of life-changing medicines. Click here to learn more.

FOCUS ON DOWNSTREAM MANUFACTURING

Challenges And Considerations For Purifying Multispecific Molecules

The structural complexity and variability of multispecific molecules presented purification challenges, from incorrect chain pairings to increased aggregation, fragmentation, and lower yield compared to standard mAbs. Developers shared how they overcame these challenges to achieve high purity and discussed key considerations for downstream developers when designing these processes. Bioprocess Online editor Tyler Menichiello explored these questions with Jian Ren, Ph.D., a principal scientist in downstream process development at AbbVie, and Mark Fitchmun, founder, president, and CEO of Somatek.

The Benefits Of Mass Spectrometry For Expediting Biologics To Patients

With increased pressure on CMC development to support shortened BLA submission timelines, mass spectrometry (MS) can be leveraged to accelerate and de-risk product and process development.

Shear and Flow In High-Productivity Membrane Affinity Chromatography

Can high flow rates and turbulent conditions compromise protein quality? This analysis explores the relationship between fluid dynamics and aggregation in membrane and resin chromatography systems.

Complex Biologic Purification : New Advances In Protein A Affinity Resins

Explore modern challenges in protein A purification, how strategic partnerships are benefiting technology innovation, and an affinity toolbox of chromatography resins.

From Bottlenecks To Breakthroughs: Mastering Buffer Management

Watch to explore strategies to overcome buffer-related bottlenecks in large-scale biomanufacturing.

Carryover Analysis Through Two Consecutive Cell Culture Harvests

Follow this ELISA testing that analyzes a protein capture device for carryover effects after consecutive cycling of two different cell culture harvests.

DOWNSTREAM MANUFACTURING SOLUTIONS

Downstream Purification Strategies And Solutions - Bio-Rad Laboratories, Inc.

Pharma+ Tubing Retainers - Nordson MEDICAL

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