Brazil produces only 5% of the active pharmaceutical ingredients needed to the manufacture of medicines. Recent changes on regulations and the COVID-19 pandemic could open the Brazilian market to a new window of opportunity where continuous manufacturing can play an important role to secure pharmaceutical supply chain.
Economic, social and political stresses have been witnessed all over the world during the COVID-19 pandemic. In particular, drug shortages and inaccessibility is one of the many results of disruption of supply chains due to shutdown of manufacturing activity in China, as well as export restrictions and bans by other countries. Herein, a brief synopsis of the knock-on effect and pre- and post COVID-19 roadmaps and measures undertaken towards achieving local drug manufacture in Africa is provided.
The pharmaceutical industry is no stranger to environmental regulation, often controlling emissions of air and water pollutants in order to minimise damage to the local environment from toxic and pharmaceutically active chemicals. This article explores the steps the pharmaceutical industry is taking in reducing its carbon footprint in a wider push to counteract climate change, a phenomenon that affects population health and on a global scale. It is good that innovative solutions to greener medicines are emerging, but these must be balanced with a willingness to investment from payers and society as a whole. Furthermore, factors incentivising this change are analysed and key focus areas are proposed to make a significant progress towards meeting the Paris Agreement’s goals.
“It is unequivocal that human influence has warmed the atmosphere, ocean and land. Widespread
As we emerge into the post-pandemic world, companies are addressing a set of strategic questions about growth, competition and innovation in a changed regulatory and geo-political environment. We draw lessons from the rollout of vaccines over the past 14 months to understand where the industry is headed and how companies can prepare themselves.
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INTRODUCTION Clinical trials are challenging by definition. Even though any clinical research entails a
Drug delivery and medical devices are increasingly becoming connected, offering real benefits to patients and healthcare providers. Such advances offer care that is safer, faster, and more convenient for patients. Patients who get information on their mobile phone on whether they have administered their drug dose correctly, for example, will not need to visit the clinic as often. These connected devices are vulnerable to a range of cyber threats with several incidents being flagged by the FDA. Addressing cyber risks requires focussed effort from the early stages of the design of the device and throughout its lifecycle.
The article outlines key recommendations to help reduce the cyber risk of connected medical devices and ensure cyber security is embedded into the design.
Antibody drug conjugates have evolved enormously from their first inception. The linker, while devoid of pharmaceutical activity, has been recognized to play a major role in the safety and efficacy of the whole ADC system. Therefore, great efforts have been spent to improve the pharmacological and biological properties of this fundamental part of ADC. Nevertheless, this has come at the expense of molecular complexity of the linker-toxin, which are now very large molecules, with tens of defined stereocenters, very flexible structures and highly hydrophilic functional groups. The technical issues, and the demanding timeframes of innovators to get to the BLA, require a modern approach for the chemical process development, very different that for small molecules. Quality by Design to prioritize the issues to address, extensive use of preparative HPLC as main control strategy, tangential flow filtration and lyophilization for recovery are the keys to the successful development and production of the most recent linker-payloads.
The pharmaceutical sector, uniquely carries out extensive testing of their products on human subjects. This testing provides data that allows toxicologists to develop safe limits for occupational exposure. However, ultra-high potent pharmaceuticals, with exposure limits below 10 ng/m3 provide challenges by pushing the containment technology and the verification of this technology to the limits of what is achievable.
