Manufacturing

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.

An industry leader since 1933, Catalent develops and manufactures over 80% of the world's Rx softgel products with 200+ products on the market in 80+ countries.

Rockwell Automation releases a new guide to functional safety for process applications.

The collaboration with Pfizer aims to develop next-generation, continuous manufacturing for solid-dosage pharmaceuticals.

Use of a continuous-flow reaction made it possible to scale up a highly exothermic reaction for the production of a key Suzuki−Miyaura coupling reagent.

Measuring headspace gas composition and pressure allows sterile product manufacturers to simultaneously monitor important quality parameters rapidly and nondestructively.

GE Healthcare Life Sciences announced that it will build a KUBio modular biopharmaceutical factory in China for JHL Biotech.

Capsugel?s Dosage Form Solutions business unit will expand facilities in France, the UK, and the US.

Presenters at the 8th Annual Forum on Manufacturing Execution Systems (MES) discuss how a vision and common terminology help companies implement MES globally.

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

Helium integrity testing offers advantages over pressure-decay testing for biopharmaceutical single-use vessels.

New weapons in the anticounterfeiting arsenal include authentication and labeling technologies.

The Biomanufacturing Research Program (BioMAN) at Massachusetts Institute of Technology (MIT) has received $10.4 Million from the Defense Advanced Research Projects Agency (DARPA) to develop new technologies and manufacturing platforms that will provide an emergency supply of medicines for front-line military medics.

FDA Issues Draft Guidance on Patient Counseling Info for Labeling

FDA updates guidance to reflect advances in technology.

Foam granulation is much easier to control under mechanical dispersion conditions, which is where most industrial processes operate.

FDA specifies the DUNS UFI system for registration of domestic and foreign drug establishments.

FDA revises boxed warnings for extended-release and long-acting opioid analgesics and postmarket study requirements.

Regulatory Authorities Discuss Elemental Impurities Standards