Quality by design (QbD) involves a science-based approach for developing drugs that is highly supported by the FDA. A robust QbD process requires an intimate understanding of the product characteristics and manufacturing process so that manufacturers can understand which aspects of the product/process are critical and which can be changed with minimal impact.



Taking a QbD approach to packaging development

Phase change material in cold chain packaging offers big benefits, but getting there requires a data driven approach

Quality advancements in CAR-T cell manufacturing

Droplet digital PCR technology strengthens quality control during CAR-T cell production

The advantages of a ‘Quality by Design’ approach in pharma drug development

At its core, the approach looks to design quality into workflows up front.

The Role of Mechanistic Understanding in QbD

The integration of scientific rationale supports the probabilistic modeling approach that is required for effective QbD implementation

Cell Therapies Come of Age: Overcoming Challenges Within the Regulatory Framework

While the field of stem cell therapy has been in development for decades, regenerative medicine is now experiencing rapid progress fueled by scientific and technology advancements...

Product Focus: Process Analytical Technologies

Interviews with product experts about select hardware/software products applicable to PAT/QbD, highlighting key features of each instrument/program

Leveraging Platform Analytical Methods for Biopharma QbD

Advances in instrumentation and techniques for critical quality attribute characterization are increasing the applicability of platform high-performance liquid chromatography ...

Evolution of Inhalation Drug Delivery

Advanced technology and rising healthcare costs have driven notable changes in inhalation therapy

Evolution in the Era of New Biopharmaceuticals

New formats and formulations will change CMC requirements

Janssen's Historic FDA Approval

The FDA has approved -- for the first time in history -- a manufacturer’s production method change from “batch” to continuous manufacturing.

What’s New in Dosage Form Analysis?

Or, what have we forgotten?

Where Is Biopharma in the PAT Picture?

The quest for “knowing exactly what’s in the soup”

How to Justify Innovation and QbD in Manufacturing

The pharmaceutical industry wants to get to the “D” in QbD, but it must overcome some obstacles to get there

PDA Annual Meeting Makes Magic

Chad Juros inspired the crowd with his story and his magic, but closed his talk by saying, "The true magicians in this world are those who are bringing these miracle treatments...

Exploring the Benefits of Real-time Particle Sizing

The optimization and scale-up of wet granulation processes is often an essential step in the commercialization of oral solid dosage (OSD) products. Granulation enables the preparation...