Still handling tablets in drums It is common to find Intermediate Bulk Containers IBCs being used for handling powders and granules in solid dosage manufacturing processes from initial Dispensing through to Tablet Compression or Capsule Filling The benefits of using IBCs for efficient and flexible materials handling at this stage of the process are widely appreciated and applied in modern facilit..
Abstract In December of chikungunya virus CHIKV an alphavirus in the family Togaviridae was introduced to the island of Saint Martin in the Caribbean resulting in the first autochthonous cases reported in the Americas As of January local and imported CHIKV has been reported in American countries with over million suspected cases CHIKV causes a severe arthralgic disease for which there are no approved vaccines or therapeutics Furthermore the ..
A customer active in the hormone production recently searched an appropriate solution for grinding material and clean packaging after the filtering and drying process The following requirements had to be met bullTo provide a safe barrier between the operator and the active drug substance to provide both operator an..
A team of Israeli researchers at the Technion has discovered two proteins that can suppress cancer and control the cellsrsquo growth and development The study was conducted in the..
With the quickening pace of global pharmaceutical regulatory drug serialization and traceability mandates the Rx Traceability Data Exchange and Architecture Workgroup TDEA began its activiti..
The number and value of capital raisings in the antisense RNAi therapy field has been steadily increasing with the past six years averaging about deals at a combined value of just over bil..
The bioprinting of tissues and organs has been big news recently However the patenting of bioprinting techniques has quietly been going on for years This article will discuss the patents covering the three process phases of bioprinting the exceptions to patent infringement for experimental uses and the prospects for further patenting and patent infringement lawsuits..
The quest to undertake biological targets that are based on the regulation of signalling pathways is challenging the classical thinking in the drug discovery arena Historically the complexity of the biological system was underestimated It is now wellaccepted that compared to old biological targets that were focused on single gene or gene products w..
Issues like approval delays deficiencies of functioning of CROs and other stake holders liabilities and compensation to injured subjects insurance issues etc still remain in India which has made multinational companies to rethink on opting for India to conduct clinical trials in India recently There is a need for a law to ensure that the people who undergo clinical trials are not exploited and should be well informed about risk as well to provide..
This article is a firsthand account of the experiences of Pharmadule in guiding leading Chinese manufacturers through facility investment projects aimed at compliance with Chinese US and EU GMP requirements These manufacturers have been among the first in the world to fully embrace the work procedures outlined in ICH Q Q and Q Implementing these guidelines in large organisations would be a challen..
The article presents a novel approach to applying Quality by Design QbD principles to the development of analytical methods Common critical parameters in HPLC gradient time temperature pH of the aqueous eluent and stationary phase are evaluated within the Quality by Design framework It is useful for the robust analytical method development and Design Space optimisation..