Manufacturing

In an attempt to strengthen safeguards against counterfeit, diverted, subpotent, misbranded, adulterated, or expired drugs, FDA issued a new final guidance for industry.

Biotechnology company Genzyme reported that FDA notified the company that it intends to take enforcement action to ensure that products are made in compliance with good manufacturing practice (GMP) regulations.

Pfizer Invests In Nodality; SOCMA Approves New Members; And More.

Why do some people contact diseases while others stay healthy? This is a central question in medicine. Similarly, why some individuals recover quickly using drug treatments while others do not is a fundamental question in pharmacology.

Person-specific cell therapy could potentially offer a cure as opposed to ongoing treatment, but it is also a disruptive technology that doesn't currently fit into traditional therapeutic manufacturing processes.

FDA issued a final rule to make cigarettes and smokeless tobacco products less attractive and less accessible to children and adolescents.

Seventeen pharmaceutical markets are now ranked as "pharmerging," according to market-research firm IMS Health.

FDA issued a new guidance for industry to help new drug applicants write the dosage and administration section of their products' labels.

Merck Ends Partnership With Dynavax; PhRMA Elects Officers; And More.

A report from Thomson Reuters claims the number of patent challenges in the US almost doubled between 2008 and 2009.

Abbott Agrees to Acquire Facet Biotech; FDA Issues Black-Box Warning For Plavix; and More.

AstraZeneca signed a license and supply agreement with the drug company and manufacturer Torrent Pharmaceuticals.

Three companies joined the University of Pittsburgh Medical Center's 21st Century Biodefense initiative to establish a flexible vaccine development and production facility.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the March 2010 edition from Munters and NETZSCH.

Recent developments demonstrate the importance of biologicals, which usually are delivered through injections, for the drug industry's future. To find out about the process of manufacturing prefilled syringes, and to learn about innovations in filling lines, Equipment and Processing Report talked to Thomas Otto, managing director of Vetter.

Continuous manufacturing could bring the pharmaceutical industry advantages such as improved product quality, easy scale-up, flexibility, and short cycle times. But how can a company switch from batch to continuous manufacturing?

Lyophiliser sterilisation is a common demand of the pharmaceutical industry.

There are a variety of vaccine types, each varying in safety and efficacy, and each possessing its own formulation challenges. To overcome potential instabilities when developing vaccines, one formulation strategy is to produce a dried product.

Freeze dryer internal surfaces become contaminated, post cycle, by the ablation of API and excipient from the freeze?drying cake.

Lyophilization is an expensive process that demands high investments in technology, but for many products, pharmaceutical freeze drying is currently the only method to ensure durability.

Technological advances and regulatory documents, such as Annex 1 of the EU Guideline for Good Manufacturing Practice, have encouraged the pharmaceutical industry to install various new technologies into their production lines.

When freeze drying biological materials, the major concern is achieving product consistency both within a batch and between batches.

Despite numerous benefits, computer modelling has mainly remained in the domain of academic research.

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

The World Health Organization released new guidelines this week for the treatment of malaria and the first-ever guidelines on procuring safe and efficacious antimalarial drugs.