Manufacturing

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.

From product development to finished patient kits, Rockwell Automation equipment is used throughout the entire process.

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.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2010 edition from ATMI and SciLog.

Effective May 1, 2010, the US Pharmacopeia has revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and can ultimately be included in an official National Formulary (NF) monograph.

In an effort to standardize quality agreements for active pharmaceutical ingredients in the drug industry, the Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates, has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.

Week Of May 10, 2010: Company And People Notes: Ariad and Merck Restructure Collaboration; Genzyme Changes Leadership; and More

In response to stringent price cuts introduced in Spain, the European Generics Association (EGA) is urging the Spanish government to adopt mechanisms that will help increase the dispensing of generic medicines.

The biotechnology markets in the United States, Europe, and Canada, and Australia reached aggregate profitability in 2009, according to Ernst & Young.

The US Food and Drug Administration sent a letter to trade associations of manufacturers, wholesalers, and pharmacies to recommend procedures for preventing and responding to the theft of regulated products.

The year 2016 will see Pfizer barely continue to cling to first place on the Top 10 pharma list, with Merck & Co. and Novartis not far behind.

McNeil Consumer Healthcare is voluntarily recalling all lots that have not yet expired of certain over-the-counter children's and infants' liquid products.

FDA Approves AstraZeneca's and Pozen's Vimovo; Merck Announces Management Changes; And More.