Manufacturing

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.

Sterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters, even when using overkill sterilization.

Wireless Network Monitors Air Cooled Heat Exchanger

Database Improves Process Efficiency

System Links Packaging Operations

Novartis files Citizen Petition with FDA to maintain naming policy for all biologics to help ensure patient safety.

GSK and the Gates Foundation will invest a combined $1.8 million in early stage research into vaccine thermostability.

The Parenteral Drug Association has established a task force to develop a peer- and regulatory agency-reviewed Technical Report that will serve as a science-based industry reference document.

An updated bioreactor based on rocking technology has more advanced controls but is easier for biopharmaceutical manufacturers to use.

Pliva?s new Oral Solid Forms Facility will increase Pliva's production capacities for tablets and capsules.

Interview of Detlev Haack, head of R&D, Hermes Pharma on the characteristics, benefits and manufacturing Methods of effervescent tablets

MedPharm opens a new topical and transdermal formulation-development services facility in Guildford, United Kingdom.

Penn Pharma partners with GEA Pharma to open a new facility for the development and manufacture of oncology drugs.

Roche's plans for a major biologics manufacturing expansion is the latest investment by Big Pharma

Kansas State University to build Bulk Solids Innovation Center in Salina, Kansas.

Parameters for steam-sterilization autoclave overkill cycles should be chosen based on process understanding.

Capacity expansions and new products meet needs for inhaler and injector systems.

Featured products from Pharmaceutical Technology's monthly newsletter, Equipment & Processing Report

The UK regulatory agency issues statement of noncompliance against Wockhardt?s site in Chikalthana, India and Wockhardt?s contract manufacturer Nestor in the United Kingdom.

Vaporous hydrogen peroxide, nitrogen dioxide, chlorine dioxide, and carbon dioxide technologies can be used in pharmaceutical manufacturing to sterilize or disinfect.

Genzyme will build a facility in Massachusetts to expand purification capacity for Fabrazyme (agalsidase beta).

Roche plans multimillion biologic manufacturing expansions in California, Switzerland, and Germany.

Recipharm has invested EUR 32 million ($43 million) in its Wasserburg, Germany site to expand lyophilization capacity.

Sepha launches BottleScan, a multi-bottle integrity tester for induction-sealed pharmaceutical bottles.

Scientific Digital Imaging's Synbiosis Division introduces SynStats statistical analysis software.