Process Development

Quality by design, process analytical technology, and high throughput screening have helped drive progress in pharmaceutical development.

Quality by Design has initiated a paradigm shift in solid dose pharmaceutical manufacturing.

Contract service providers describe how quality by design has influenced a drug sponsor's expectations of suppliers.

Laser Diffraction Software Supports Analytical QbD

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

Agencies extend successful pilot program to further harmonization of QbD topics.

Traditional project decision-making is compared with a QbD approach.

Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.

Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing.

Covance Inc. and Pathoquest have announced a collaboration to provide next-generation sequencing (NGS) based biosafety assessments to detect and identify viral contaminants within biologic compounds.

EMA and FDA publish joint QbD guidance on design space verification.

The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs.

The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs

Case studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.

Agencies collaborate to ensure consistent product quality.

Until recently, glycan analysis has been a slow, labor-intensive process more widely used late in bioprocess development. New high-throughput methods are changing that.

An introduction to the upcoming Interphex panel--Lessons Leaned: Successes and Challenges in Implementing Quality by Design.? Moderator: Jennifer Markarian, manufacturing editor, Pharmaceutical Technology. Panelists: John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck and Co. Chris Moreton, FinnBrit Consulting Jonathon Thompson, senior manager of Compliance Services Consulting at Invensys Operations Management

The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.

Keith Bader, senior director of technology at Hyde Engineering + Consulting discusses his presentation ?Establishing a design space: cleaning process development and validation,? which will be presented at Interphex 2013

The authors present topics discussed and conclusions that resulted from the PDA QbD workshop.

Factors for assessing excipient variability, the associated challenges developers need to address to design and manufacture solid oral drug products, and solutions for such challenges are examined.

The author discusses current expectations in bioprocessing and lays a framework for using NMR to enhance a QbD approach.

The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.

This study examines the effect and interaction of variations in hypromellose physicochemical properties.

Meticulous system configuration can prevent machines from taking over.

The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes.

Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.

A technical forum featuring Tim Freeman of Freeman Technology and Carl Levoguer of Malvern Instruments.

Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.

On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.