The evolution of therapeutic modalities drives the adoption of single-use technologies.
Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
Singapore (Mar. 29)-The contract manufacturing organization Lonza Group (Basel, Switzerland) and Bio*One Capital (Singapore) broke ground for their large-scale commercial mammalian cell-culture manufacturing facility at Tuas Biomedical Park in Singapore.
Thousand Oaks, CA (Apr. 3)-Amgen, Inc. has provided a new schedule for the completion of a new manufacturing facility in County Cork, Ireland.
Washington, DC (Apr. 2)-The US Department of Homeland Security released an interim final rule that imposes federal security regulations for high-risk chemical facilities.
Alternatives to batch processing finally are starting to be taken seriously by pharmaceutical manufacturers, but the implemention of continuous processing is still in its infancy, and many challenges remain.
Many radio frequency identification projects are moving beyond the pilot stage, supported by new hardware and software tools.
The authors prepared and tested press-coated tablets with various weight ratios of ethylcellulose to hydroxypropylcellulose (HPC) and various ratios of two different batches of HPC as an outer coating shell and fillers in core tablets. The tablets were examined for changes in time lag and release patterns of salbutamol sulfate.
Near-infrared (NIR) assay and content uniformity of tablets provide fast, accurate means of monitoring tablet production that are in step with FDA's process analytical technology initiative.The authors discuss the process for testing a newly released NIR tablet analyzer to determine instrument precision and accuracy using chlorpheniramine maleate tablets.The data show promising results that could relieve laboratory workload of high-performance liquid chromatography analysis and bring analysis closer to real time for process monitoring.
Manufacturers use various techniques to transfer sterile liquid. Some methods, however, cannot accommodate disposable equipment, and others cannot transfer through barriers. This article describes a new approach for aseptic fluid transfer that was developed to provide a high-quality aseptic connection and simplify passage through a wall. The authors discuss the product-qualification results for the approach, which show that the technology and its various components meet pharmacopeial product-qualification requirements.
This article considers the distinction among the terms qualification, validation, and verification in the context of pharmacopeial usage.A recommendation for a standardized usage of the terms validation and verification is provided,and general requirements for validation and verification activities are given.The article also emphasizes the importance of knowing when validation or verification is necessary relative to the use of a method to satisfy pharmacopeial article requirements (for which a monograph exists in the pharmacopeia) or for nonpharmacopeial use.
The pharmaceutical industry plans moderate increases in spending for equipment and machinery in 2007 as expenditures hold steady.
A wealth of citations helps illustrate the applicability of the analytical methods and also highlights their pitfalls.
... there is a huge manufacturing challenge involved in bringing cell therapies (especially stem cell therapies) from the lab bench into the clinic.
So what is the EU to do? It must grant its younger researchers greater scientific autonomy and academic independence.
Missed or late calibration dates can accumulate, and even if the equipment is labelled appropriately, it can suggest poor management of resources and priorities.
When a dosage form or an API is introduced to the gastrointestinal tract, or dissolution media mimicking it, a transformation from a metastable to a more stable form with lower solubility and bioavailability is possible.
Agawam, MA (Mar. 26)-Contract manufacturing and testing laboratory Microtest signed a manufacturing deal with Antisoma to produce AS1411, a new drug being developed for the treatment of various cancers.
South San Francisco, CA (Mar. 28)-Genentech, Inc. announced plans to invest $140 million in 1000-liter manufacturing facility in Singapore.
Midland, MI (Mar. 21)-The Dow Chemical Company formed an alliance with Colorcon, Inc. for the global marketing, sales, technical service and development, and distribution of Dow pharmaceutical excipient products for use in controlled-release applications.
Improving performance at an active pharmaceutical ingredient manufacturing plant involves an integrated approach that incorporates methods for optimizing total production management, quality control and assurance, and inventory management. The authors analyze results from a recent benchmarking study to evaluate the critical success factors in high-performing API manufacturing plants.
Berlin and Basel, Switzerland (Mar. 26)-Bayer Schering Pharma AG and Novartis reached an agreement over multiple sclerosis therapy ?Betaseron.?
Paris (Mar. 15)-Sanofi-Aventis plans to close its manufacturing site in Waterford, Ireland.
Bangalore, India, (March 14)-Bristol-Myers Squibb Company is expanding its research and development (R&D) capabilities in India.