Newsletter | October 28, 2026

10.28.26 -- When Lyophilization Fails At Scale, First Scrutinize Your Formulation

SPONSOR

Developing a scalable, GMP-ready AAV8 production platform is complex and requires a unified approach across upstream and downstream operations, data-driven decisions, and efficient progression from bench scale to manufacturing-relevant volumes. In this white paper, Matica Biotechnology and Sartorius demonstrate how collaboration enabled the design, optimization, and scale-up of an integrated AAV8 process to 50L with reproducible performance, sharing practical lessons in upstream optimization, downstream purification, capsid separation, and analytics to support flexible gene therapy manufacturing.

FOCUS ON FILL-FINISH

When Lyophilization Fails At Scale, First Scrutinize Your Formulation

When lyophilizing a challenging biologic drug product, use an integrated approach optimizing formulation and process parameters together.

Unlock The Power Of Biophysical Tools In Biotherapeutic Development

Unlock innovation in biotherapeutics with expert insights into DSC and molecular stability. Learn how biophysical techniques can optimize formulations and enhance nucleic acid stability.

3 Decision Domains Shaping Sterile Drug Product Success

In sterile development, the decisions with the greatest downstream consequences are rarely recognized as such when they are made. Examine how these choices shape program outcomes across the lifecycle.

Validating Tubing For Closed-System Bioprocessing

Uncover how advanced tubing materials improve weld integrity, reduce particulates, and support sterilization compatibility for closed-system bioprocessing.

Benefits Of Isolator Technology In Fill-Finish

Isolator technology enhances sterility assurance, reduces contamination risk, improves operator safety, and supports regulatory compliance, making it essential for modern aseptic fill-finish operations.

FILL-FINISH SOLUTIONS

•

New Facility, New Filling Line: A Sterile Fill-Finish CDMO - Grand River Aseptic Manufacturing

•

Aseptic Filling Strategies With Speed, Precision, And Contamination Control - Cytiva

•

Mitigating Risk With The Right Contract Manufacturing Partner - West Pharmaceutical Services, Inc.

FOCUS ON DOWNSTREAM MANUFACTURING

Productivity Gains Upstream Apply Pressure Downstream

In this segment from the Bioprocess Online Live event, “The Levers And Tradeoffs That Drive Process Productivity,” panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), reflect on the progress that’s been made in terms of productivity gains and the “ceiling” that mAbs face, and how these upstream gains stress downstream operations. They also discuss how molecular complexity relates to challenges in purification.

High-Throughput Innovation In Action

Explore the growing demand for high‑concentration biologics, and the formulation, viscosity, and manufacturing challenges driving new technologies for stable, scalable drug development.

How Do You Protect Incubation Workflows From Contamination?

Active HEPA filtration protects cell cultures by restoring air quality within minutes. Find out how continuous purification reduces contamination risks and ensures reliable, reproducible research.

How Innovative Valve Design Drives Efficiency And Product Protection

Thoughtful design at the bioreactor and ATF interface can reduce shear, simplify fluid paths, and conserve space. See how rethinking an overlooked valve assembly helped improve process efficiency.

SPTFF High Concentration mAb Formulation

Gain insight into how single-pass tangential flow approaches improve efficiency, scalability, and product quality while addressing key development and processing challenges.

Chromatography Polishing In The Age Of Intensification

As upstream processes intensify, chromatography polishing must handle higher loads and evolving impurity profiles. Modern strategies can improve clearance, extend resin life, and maintain throughput.

Why Sterile Manufacturing Matters For ADC And CDMO Success

Rising complexity in ADCs and biologics makes sterile manufacturing more critical than ever. Discover approaches to outsourcing, lyophilization, and quality management that support success.

DOWNSTREAM MANUFACTURING SOLUTIONS

•

Advanced Purification To Improve Your Manufacturing Efficiencies And Timeline To Clinic - Ecolab, Purolite™ Resins

•

A Buffer Management System For Inline Buffer Preparation - Cytiva

Connect With Bioprocess Online: