Manufacturing

Q&A with Robert Hardy, chief executive of Aesica

Social media tools have taken over many aspects of our lives, now including regulatory info.

The author provides an overview of QbD implmentation for biopharmaceuticals.

Just when things seem to be looking up, the unexpected problem occurs.

The authors review a compliance-by-design approach to quality systems.

Pharmaceutical Technology's annual survey on equipment and machinery reveals the spending levels and type of spending made in 2010 and planned for 2011.

The author challenges current detection methodologies.

As drug shortages make headlines, FDA tests the Sentinel safety system and its efect on healthcare.

This report provides plans for the USP Council's work in the 2010-2015. This articles contains online bonus material.

INTERPHEX 2011 aims to address the industry's unique characteristics.

The authors outline the key decision points FDA must consider in putting forth a US regulatory pathway for biosimilars.

This article is Part I of a three-part series on biopharmaceutical issues in public health, government, and developing-world markets. Part 1 focuses on drug-development. Part II, which examines manufacturing, appeared in the April 2011 of Sourcing and Management. Part III, which analyzes distribution and administration,appeared in the May 2011 issue.

Contract manufacturers and fine-chemical suppliers announce capacity expansions and service enhancements of Informex.

Many solid oral dosage forms do not dissolve at the correct place in the gastrointestinal tract for them to be absorbed into the bloodstream. Could magnets solve the problem?

Use of in-process particle size analysis has enabled pharmaceutical scientists and process engineers to track the progress of a granulation process and detect its endpoint.

There are two types of widely used dry granulation methods: slugging and roll compaction. Currently, roll compaction is preferred to slugging because it offers greater capacity and ease of process control.

In wet granulation, many companies used to rely on empirical data and quality control, but processes and technologies have improved in a variety of ways in recent years.

Pharma's manufacturing and supply chain needs a "radical overhaul" because it is underused, inefficient and ill-equipped to cope with new types of products that will be coming to market in the near future, according to a report from PricewaterhouseCoopers (PwC).

Gilead to Acquire Calistoga; Bayer Healthcare Appoints Former Pfizer Exec; and More.

Last Wednesday, sanofi aventis agreed to acquire Genzyme for $74 per share in cash, or approximately $20.1 billion.

President Barack Obama released his budget proposal for fiscal year (FY) 2012, which shows an increase in funding for the US Food and Drug Administration.

Company and People Notes: sanofi to Acquire Genzyme; Lilly Makes Senior Appointments; and More.

US Senators Amy Klobuchar (D-MN) and Bob Casey (D-PA) introduced the "Preserving Access to Life-Saving Medications Act," which is intended to help address and prevent shortages of prescription drug medications.

A major pharmaceutical micronizing company consulted Telstar when it needed a mobile, high-containment isolation system suitable for housing 4-, 8-, 12-, or 15-in. micronizing jet-mill systems during the loading, milling, and offloading processes.

My drug failed a light-obscuration test, but after I filtered the drug for microscopic particle counting, I couldn?t see any significant particulate on the filter. What might have caused the failure, and why is it not visible?