The ultimate goal of a template is to help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed.
The growth in outsourcing is one strategy life science innovators are pursuing to address the evolving pharma landscape; however, should a sponsor company seek the traditional route of utilizing multiple partners across the supply chain or does an integrated CDMO offer a more efficient and faster path to commercialization?
Despite their potential to increase the efficiency healthcare, autologous cell therapy treatments present significant challenges to most companies when it comes to development and manufacturing.
One tool holds a unique position among R&D informatics systems -- electronic laboratory notebooks (ELNs). ELNs both produce data and consume information and are particularly powerful.
At the end of the day (or several years), sponsors and the FDA ideally work collaboratively during the drug development process, having a shared public health goal of making safe, effective, and high-quality drugs available to the American public as quickly as possible.
About a month ago, I was offered a tremendous opportunity: to attend a media trip to Thailand to learn about the country’s burgeoning life sciences industry. Like many people in the life sciences industry, I had no idea just how much has been going on within the country in terms of life sciences.
Alvotech's facility features a high-yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes,and end-to-end upstream/downstream automation.
While existing cGMP processes are likely to continue using stainless steel infrastructure, many new products are going directly into single-use production equipment.
The significant interest in semi-solid systems for the potential of extended release profiles has prompted researchers to develop alternative encapsulating systems.
An innovative biotechnology company exploring novel therapeutics for neuroscience indications had developed a promising new chemical entity for the treatment of a severe pediatric genetic disease.
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