Process and Scaling

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

Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.

Agencies collaborate to ensure consistent product quality.

CDER withdraws some outdated guidance documents and makes plans to finalize others.

Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The author, Marga Vines from Grifols International, analyzes a project for an injectable drug for which a new drug application was submitted to FDA.

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

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.

ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages.

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.

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

Prefilled-syringe line features automation and novel disinfection techniques.

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

Victor Hernandez of EMD Millipore discusses his upcoming session, "Current continuous process validation program: following FDA current guidelines,? which will be held 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.

Process chemists employ a variety of approaches to improve yield, purity, and stereoselectivity.

To ensure the accuracy of scientific testing, protect the subjects to avoid data contamination.

Even when all is well at the facility, one must expect the worst while braving the elements.

This article focuses on the growing need for effective data management in the life sciences industry-especially among smaller pharmaceutical manufacturers.

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.

Only the strong survive when it comes to pharmaceutical packaging and shipping.

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

Ties between the biotechnology industry and university research are crucial.

International trade can be great for business, but breaking border laws can put one in hot water.

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.