Manufacturing

Editors' picks of pharmaceutical science and technology innovations.

A timely new book explains techniques for conformational analysis.

Europe moves to place excipient GMP and GDP standards on the same level as active pharmaceutical ingredients.

Too much or too little control can actually lead to the same result.

The authors recommend a strategy for classifying similar nonstainless-steel surfaces into three groups based upon the analytical recovery that was observed in this study.

Granulation is the most crucial step in the manufacture of solid dosage forms.

The requirements of a granule drying process haven't really changed much in recent years.

A laboratory information system (LIMS) is a key tool in facilitating communication between a pharmaceutical company and its outsourcing partners; however, most LIMS require extensive customisation before they can be used in the pharmaceutical industry.

An effective quality management system will identify the root cause of non-conformances and put measures in place to ensure that they do not recur, but is the pharmaceutical industry choosing the right methods to make sure this happens?

An environmental risk assessment (ERA) is now required for all new pharmaceutical product marketing authorisation applications. The author outlines the steps to this procedure.

Compressed tablets are the most popular solid dosage form and, despite having been used for many years, still offer numerous advantages.

The market for tablet compression technology and the demands placed on equipment manufacturers have changed quite significantly in recent years.

Shared audits of suppliers offer several advantages, but networking to conduct such an audit can be challenging.

Tablet coding or identification is based either on the detection system being overt (visual to the naked eye) or covert (non-visual). The coding of tablets is obvious at an overt level because of size, shape, colour and logo design.

We regularly deal with tabletting equipment problems and malfunctions, and find that the most common cause is misuse or improper handling and transportation, which often leads to accidental damage to tablet punches (including nicks and dents to the punch tip edges).

Despite its potential, why is personalised medicine still not widely used in healthcare?

The requirements of a granule drying process haven?t really changed much in recent years: pharmaceutical companies still need a process/technology that is capable of drying the produced granules as fast as possible, without affecting critical quality attributes (CQAs), such as particle size and homogeneity.

The market for tablet compression technology and the demands placed on equipment manufacturers have changed quite significantly in recent years. This has been driven by a number of factors.

One of the biggest changes in recent years that has impacted tablet coating technologies is the introduction of 21 CFR Part 11, which deals with electronic records and electronic signatures.

Granulation is the most crucial step in the manufacture of solid dosage forms because it provides the main physical modification to the product bulk that affects the rest of the production downstream and, of course, the characteristics of the final form.

Thanks to the Integrated Architecture solution from Rockwell Automation, the Swiss company could help its customers improve productivity.

Bayer to Open San Francisco Innovation Hub; Lonza Bioscience Names COO; And More.

Genzyme (Cambridge, MA) signed a consent decree of permanent injunction that requires the company to correct manufacturing-quality violations at its Allston, Massachusetts, manufacturing facility.

Signaling its interest to strengthen its presence in emerging markets, Abbott (Abbott Park, IL) has agreed to acquire Piramal Healthcare Ltd.'s (Mumbai, India) Piramal Healthcare Solutions business (domestic formulations) for $3.72 billion.

More acquisitions are expected as the patent cliff pushes the pharma industry into a critical phase, with many executives believing that the industry will be unable to innovate sufficiently from within to replace blockbuster drugs.

Lonza Acquires MODA; Sigma-Aldrich Exec to Retire; And More.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published its "Ten Principles on Counterfeit Medicines" last week to draw public attention to the issue.

Pfizer (New York) announced this week plans to reconfigure its global manufacturing network as part of its integration following its $68-billion acquisition of Wyeth (Madison, NJ) in 2009.

Life-sciences companies spend proportionally more resources on information technology and get less in return on their investment than companies in other industries. The poor return on investment partly results from regulatory costs that are unique to the pharmaceutical industry, but also stems from a failure to manage data strategically.

Online process monitoring could help companies achieve the dual goals of ensuring high end-product quality and satisfying regulatory demands.