Manufacturing

Emerging markets remain an important element in the strategies of pharmaceutical companies and their suppliers.

Pre-Interphex 2010 Product Releases.

Current methods for establishing visible residue limits (VRLs) are not statistically justifiable. The author proposes a method for estimating VRLs based on logistic regression.

In Part I of this article, the authors describe the materials and methods used in developing a screening strategy to accelerate the preparation and characterization of spherical agglomerates by spherical crystallization.

To best carry out the vision of Hatch-Waxman, Congress must act now on biogenerics.

Brief pharmaceutical news items for March 2010.

Analysis of the opportunities and challenges in the biosimilars market.

FDA modernizes information systems, expands access to drug safety and use information.

From last-minute product inserts to putting out fires, close calls are a common occurrence.

It's time to maintain a thorough traceable excipient trail.

If both sides of the aisle don't agree on even mild healthcare reform soon, the bill could die out.

The vice-president addresses shifts in process and more.

Technological developments make it easier to manufacture sterile parenterals.

Visitors to INTERPHEX 2010 will find an abundance of packaging innovations. Plus: Check out our preliminary program for LIVE video interviews at the show.

The author reviews the benefits, challenges, and considerations to be made when selecting a gamma-irradiation sterilization method.

Although efforts have been made to improve solubility, many poorly soluble drugs still reach the market. Peter Nielsen discusses new developments in solubilisation technology, which could help those companies seeking to reinvigorate marketed products.

The authors describe an industrialized process for the manufacture of iPSC-derived human cardiomyocytes. This article is part of a special issue on Bioprocessing and Sterile Manufacturing.

Single-use technologies can help simplify equipment and facility design, thus bringing cost advantages. But how are these cost advantages realized and what criteria can be used to assess their impact? This article is part of a special issue on Bioprocessing and Sterile Manufacturing.

The second annual Pharmaceutical Technology Bioprocessing Survey offers a snapshot of the industry following 2009's megamergers.

The author examines the use and advantages of disposable technologies in the fill–finish of sterile pharmaceutical products and how these technologies can reduce costs and time in producing clinical-trial materials.

Pharmaceutical Technology talked to drugmakers, equipment vendors, and service providers to learn more about the advantages and disadvantages of rapid microbial-detection methods.

The authors propose a process-centric approach for carrying out aseptic-processing and suggest further dialogue. This articles contains bonus online-exclusive material.

Freeze drying is widely used in pharmaceuticals to improve the long-term storage stability of labile drugs.

A Q&A with GE Healthcare

The authors propose increased use of single-use technologies in biopharmaceutical manufacturing to achieve operational excellence without compromising product quality.

Moisture-activated drying granulation is a simple and effective process for particle size enlargement.

The most important consideration when choosing a freeze dryer is to ensure the system is fit for both today's applications and future needs.

Pharmaceutical Technology Europe discusses some of the latest challenges and innovations in pharmaceutical lyophilization.

Last year, a member of the PTE editorial team attended the 2nd Annual Lyophilisation Conference in London (UK).

Could a collaborative approach involving both public and private parties offer a solution to Europe's lack of innovation?