Impact of ATMP Manufacturing on Process Equipment and Facility Design

Advanced therapy medicinal products pose unique manufacturing challenges that will require appropriate and thoughtful facility design and equipment.

Single-Use Mixing Technology for Virus Clearance (Part 2: Compatibility, Leachables, and Scale-Up Studies)

The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.

Media Requirements for Different Cell Sources

This article will explore the requirements for media and supplements needed to maintain newer cell lines, such as those based on human cells and fungal cells.

Screen Hundreds of N-Glycans per Day: More Samples – Better Decisions – Faster

Fast-Track Clone Selection and Cell Line Optimization Workflows: Automating Sample Prep to Screen Hundreds of N-Glycan Samples per Day

Timely, Accurate Analytical Purity Data Helps to Avoid Late Surprises When Scaling Up

Single-Use Bioprocessing Equipment Trends and Adoption by CMOs

The growth in adoption of single-use systems for commercial manufacturing will be dramatic in coming years.

Lonza Expands Parenteral Dosage Form Capabilities

The expansion adds new capabilities and enhances existing service offerings for both oral and parenteral dosage forms.

Innovation and Industry Strength Recognized at CPhI

Survey results and record attendance may show positive signs for established and emerging biopharma regions.

Barriers and Solutions to Effective External Collaboration in Biopharma

As biopharma companies rapidly change their focus, they may lack the laboratory space, instrumentation, and the scientific knowledge to support biologics research.

Impact of ATMP Manufacturing on Process Equipment and Facility Design

Advanced therapy medicinal products pose unique manufacturing challenges that will require appropriate and thoughtful facility design and equipment.

USP Proposes a New Chapter for Rapid Sterility Testing

The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.

Study on an Inactivation Evaluation Method of Cleaning Processes for Biopharmaceuticals

This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.