catalent
The pharmaceutical industry has experienced a trend in the number of accelerated approval designations for drugs (e.g. orphan drugs, breakthrough therapies, accelerated approvals, and FDA priority reviews) being developed. These designations are given shortened timelines for product development, product assessment and commercial scale-up (typically between 3-5 years) and come with several development and manufacturing challenges. In this webinar, you will hear from industry experts on overcoming scale-up challenges and fit-for-purpose manufacturing strategies.
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Nitrosamines are potential mutagens and need to be controlled in human drug products. Recently, nitrosamine contamination of high-profile drugs has prompted numerous recalls, and increased regulatory assessments for marketed products.
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Systechone
Serialization is a great achievement for our industry. However, most executives now realize that it is only part of the solution, and serialization alone cannot solve the escalating problems of counterfeiting and diversion within the pharmaceutical industry. The global value of pharmaceutical counterfeiting is $200B annually. More staggering is that the gray market is forecasted to reach almost $3 trillion by 2022.
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T3P or propanephosphonic acid anhydride, is an exceptional green reagent for use in condensation reactions and has attracted the attention of almost all innovative pharmaceutical companies worldwide during the past decade.
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