Manufacturing

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.

HERMES PHARMA has pioneered user-friendly dosage forms. Our effervescent and chewable tablets, lozenges, orally disintegrating granules and instant drinks are convenient to use, easy to swallow and taste good.

Pfizer, Eli Lilly, and several other pharmaceutical companies are participating in the development of automated sampling technology and associated software that improve process control and reduce development times in biopharmaceutical manufacturing.

Aesica expands aseptic capabilities at its Nottingham, UK site with the acquisition of new pre-filled syringes manufacturing equipment.

Fujifilm Diosynth Biotechnologies has renewed its manufacturing license from the UK's MHRA.

After realizing benefits from the adoption of a single-use filling line for one specific product, Patheon took the leap and installed a single-use filling line in a new facility.

A recent market analysis offers a promising outlook for contract fill-finish and lyophilization services.

Advanced Biosciences Laboratories will support the development and production of a novel Shigella vaccine candidate for PATH.

The sterile injectable manufacturer Ben Venue decides to end production despite efforts to remediate cGMP violations.

The US Department of Health and Human Services awards contract to four companies for Fill–Finish manufacturing for pandemic influenza vaccines.

Temperature-sensitive pharmaceuticals and biologics depend on a variety of services and technologies to establish, maintain, and verify proper storage and transport conditions.

GlaxoSmithKline?s sale of its thrombosis brands is part of a focus on its late-stage pipeline.

Fujifilm Diosynth Biotechnologies? new mammalian cell-culture facility uses primarily single-use technologies.

USP seeks input from stakeholders on new and revised standards to mitigate extractables and leachables in plastic packaging systems.

RheocalcT Software Tests Parameters and Data Collection

The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.

Manufacturing standards are considered key to preventing drug recalls and shortages.

The rapid uptake of single-use vessels for use in bioprocessing applications has made assuring integrity that much more crucial; helium integrity testing can be used to test integrity and prevent failures.

Industry experts discuss the importance of characterization studies during biosimilars development and related analytical methods.

Analytical methods are being used to troubleshoot tablet-sticking problems and to develop screening methods and predictive models to more quickly find solutions.

Fluorinated molecules play an important role as pharmaceutical compounds. Recent advances seek to overcome the challenges of selective and late-stage insertion of fluorine into small molecules.

3M introduces a rugged comfort respirator for harsh working environments.