PTSM: Pharmaceutical Technology Sourcing and Management-10-07-2015

The high cost of disposables is a factor in restricting adoption of single-use devices.

The use of low-temperature chemistry can often lead to more direct, cost-effective routes to sophisticated pharmaceutical compounds.

FDA selected USDM Life Sciences, RC Partners, and The Clarion Group to develop and implement a DSCSA pilot project.

Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.

Sterigenics International will triple West Memphis sterilization capacity with $15 million expansion.

The Grünenthal Group’s Tecnandina manufacturing plant in Ecuador has received the country’s first certification from the Regulatory Authority of Brazil.

Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.

The CDMO is striving to become a market leader in the development and manufacturing of antibody-drug conjugates.

Pharma development and manufacturing firm Patheon announces new tagline and logo.

The agency releases guidance on controlled correspondences related to generic-drug development.

Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.

Cobra Biologics and the University of Manchester announce a collaboration to improve industrial scale-up of mammalian cell bioprocessing.

ReposiTrak signs agreement to pilot track and trace system in pharma.

Supersonic spray-drying process yields stable and soluble amorphous nanoparticles.

EMD Millipore, the Life Science business of Merck KGaA, introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials, which include excipients, process chemicals, and APIs.

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.

GS1 standard tracks movement and status of goods, enabling better visibility, security and regulatory compliance.

PharmSource forecasts slow growth in a new report on the outlook for the contract manufacturing industry.

SGS Life Science Services announced that its facility in Fairfield, NJ, has been upgraded to be Biosafety Level 2 (BSL-2) compliant, according to the Centers for Disease Control and Prevention (CDC) guidelines.

United Cargo signs global rental agreement with va-Q-tec for controlled transport of pharmaceuticals.