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Technology advances foster new therapies.
In the past 16 months, the public gained some insight into the complexities of drug development. The rapid development and emergency approval of the Pfizer/BioNTech and Moderna COVID-19 messenger RNA (mRNA) vaccines should not, however, give the impression that these tasks were easy. These innovations were built on years of research, with setbacks and successes.
The development of new drug modalities, such as mRNA vaccines, push researchers to develop bespoke technologies, methods, and processes to meet scientific, safety, regulatory, characterization, and manufacturing requirements for innovative treatments.
The cover story for this issue examines how researchers developing emerging biotherapies must address unique challenges associated with cell therapies, intranasal vaccine delivery, and virus-like particles, as well as the cold-chain limitations of mRNA vaccines. The solutions to these innovation hurdles will have implications for the success of future new biotherapeutic modalities and can set the stage for future life-saving treatments.
Some innovations are happening at the particle level, as formulators look for ways to engineer APIs to improve solubility, permeability, and release profiles to better target drug delivery using milling, spray drying, and other processes. The emergence of potent biologic drugs creates the need for risk assessments for operator exposure and manufacturing containment requirements. Learn how these challenges are being addressed in the Development articles in this issue.
As the pandemic-related headlines fade, the routine of bio/pharma development and manufacturing continues, with efficacy, safety, and quality at the forefront.
The potential for cross contamination is a major concern in multi-use drug manufacturing facilities; cleaning and cleaning validation are frequent targets of regulatory inspections. This issue looks at best practices for cleaning continuous manufacturing systems as well as recommended cleaning validation strategies.
In addition, the editors report on ways drug compounding facilities are turning to robotic technology to reduce the risk of human error, streamline operations, and improve good manufacturing practices.
Emerging technologies and improving basic operations will continue to be bio/pharma industry themes and will be the ongoing focus of coverage in Pharmaceutical Technology.
Mike Hennessy, Sr. is chairman and founder of MJH Life Sciences™.
Vol. 45, No. 6
When referring to this article, please cite it as M. Hennessy, “” Pharmaceutical Technology 45 (6) 2021.