Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

Reshaping Dosage Forms

This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

Frontrunners in Bispecific Antibodies

Topic

Articles

This risk-management case study focuses on assessing empty capsules.

PQRI Case Study (4): Process Deviation and Empty Product Capsules

In a 2004 guidance, FDA says that the "use of redundant sterilizing filters should be considered in many cases." But not all manufacturers agree on what redundant filtration is.

Can Redundant Filtration Make Sterility Assurance Double Sure?

The International Society for Pharmaceutical Engineering will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide and contain practical information about technological advances in sterile manufacturing.

ISPE to Publish Updated Sterile-Product Manufacturing Guide

Podcasts

Meeting Co-Chair Susan Schniepp provides insight into this year's regulatory conference.

PDA-FDA 2011 to Focus on Compliance

Amy Ritter was Scientific Editor, BioPharm International.

Representatives from FDA, the Generic Pharmaceutical Association, the European Fine Chemicals Group, and a task force from the Society of Chemical Manufacturers and Affiliates are nearing completion of draft legislation for the Generic Drug User Fee Act.

Generic Drug User Fee Agreement Nears Completion

Powder Systems Ltd's (PSL's) new GFD&#153; isolator combines the latest innovation to provide a high containment lab scale filtration and drying solution with the same reliability and benefits as PSL high containment production size filter dryers.

New lab glass filter dryer isolator technology

The author prepared and analyzed a detailed design of experiments for the manufacture of a simple tablet formulation. The aim was to test whether tablet hardness and weight could be controlled during the compression process by adjusting certain machine parameters.

A Design of Experiments for Tablet Compression

Elham Blouet is Pharmaceutical Project & Development Manager, Pharmaceuticals & Cosmetics BU, at Roquette.

Elham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.

Carbohydrates For Injection

A Q&A with Joe Cascone, director of potent pharmaceutical development at Metrics, moderated by Patricia Van Arnum. Discussion of the key considerations made in facility design, equipment selection, and operations to achieve desired levels of containment.

Achieving Containment in High-Potency Manufacturing: A Case Study for Solid Dosage Manufacturing

Highly potent APIs (HPAPIs) represent a growing area of interest for the pharma industry. Mark Griffiths, CEO of Carbogen Amcis AG, explains why.