Manufacturing

The authors evaluate the thermal properties of gentamicin sulfate as a small-molecule drug model in optimizing the freeze-drying cycle.

Peptides and related technologies to are starting to improve production.

New product reviews for June 2012.

Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.

Industry wants more innovation, but can suppliers meet customer needs?

A Q&A with Larry Kadis, President and CEO of Federal Equipment, on recent industry trends.

Highlights included the latest in pharmaceutical packaging equipment, containers, and labels and new capabilities among contract service providers.

BIO is calling for a more patient-centric approach to user-fee reauthorization.

How to avoid invisible and airborne contamination.

US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.

New price-control policy has domestic and global firms waiting on the sidelines to launch products.

New coating technologies achieve high uniformity and reduce waste through mixing system advances and pan and airflow configuration.

UK chooses to use off-label drug indication to cut healthcare costs. Will others follow suit?

New legislation, government programs aim to bolster drug discovery and reduce regulatory hurdles.

Does global development have to entail multiple comparability studies?

Even the slightest of errors in exponential calculations can cause the biggest of headaches.

Nick Beckett from the UK law firm CMS Cameron McKenna explains how the UK government's proposed Patent Box legislation may impact the pharmaceutical sector.

The globalisation of clinical trials is putting pressure on the European Medicines Agency.

The EDQM (European Directorate for the Quality of Medicines and HealthCare) are looking to recruit a Scientific Programme Officer to join the team for a five year period to organise, manage and monitor a number of projects related to Pharmaceutical Care and Anti-Counterfeiting activities with a particular focus on the implementation of the MEDICRIME Convention

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2012 edition from Koslow Scientific Company and Vaisala.

We are using a vacuum oven to dry our wet-cake intermediate. At 120 °C, it takes 26 hours on average to dry the material from 80% to 10% moisture. Can we shorten our drying time, possibly by agitating the product to improve heat transfer?

Advances in process analytical technology and in defining lots for release are key for enabling use of continuous processes in solid-dosage manufacturing.

Properly identifying and classifying rouge, a form of surface corrosion that comes in many forms, is important in determining whether it may be affecting product quality and whether further actions are necessary.

FDA issued a final rule on sterility testing on May 3, 2012, which amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Many steps are changed or eliminated.

The UK's Medicines and Healthcare products Regulatory Agency has launched a new anticounterfeiting strategy with the aim of curbing the occurrence of falsified medicines in the county's supply chain.