Journal Articles
Journal Article
The steps involved in manufacturing pharmaceutical products require rigorous processes to ensure the safety of patients. One important such process is cleaning validation — a critical element in current good manufacturing practice (CGMP).
Journal Article
There has been a continuous flow of new guidance documents and updates since the Clinical Trials Regulation (CTR) and accordingly adapted European Union Member State (MS) law became applicable on January 31, 2022. New information is communicated through different channels by the European…
Journal Article
Leadership is often thought of as driving productivity and business growth. For many years, leadership has been focused on results, earnings and being competitive. For me, however, a primary characteristic of leadership is authenticity.
Journal Article
The COVID-19 pandemic exposed significant challenges in the pharmaceutical global supply chain, leading to severe shortages of drugs and vaccines worldwide. This resulted in a pronounced inequity in distribution, particularly disadvantaging the Global South. This disparity is largely due to the dependency of low- and middle-income countries (LMICs) on pharmaceutical manufacturing in more industrialized nations. To mitigate this inequity and ensure supply of medicinal products across the globe, manufacturing of medicinal products needs to be decentralized through the establishment of manufacturing sites in LMICs.
Journal Article
Londa Ritchey’s expertise in quality operations, oversight, and management has been integral to PharmaLex’s success. Leveraging her strong background in microbiology and biostatistics, she effectively manages operational plants, supervises global manufacturers, and navigates complex challenges, ensuring the highest standards in the pharmaceutical sector. In an interview with Pharma Tech Outlook Europe, Londa shared her positive outlook on emerging pharmaceutical manufacturing trends and the promising uptake of rapid micro methods, enabling swift responses to challenges.
Journal Article
On November 23, 2023, the PDA Ireland Chapter hosted an event on Microbiology – The Key to Compliance with Annex 1 and Risk Based Regulations. This sold-out event was led by industry leaders, experts, regulators, and pharmaceutical company representatives and was attended by professionals from across Ireland as well as overseas.
Journal Article
Aseptic manufacturing of medicinal products has evolved rapidly over the last number of years, as a result of the development of numerous new applications and technologies.
Journal Article
The rapid global response to the COVID-19 pandemic showed how remarkably fast vaccine development can be with a coordinated effort from biopharmaceutical companies, government organizations, regulatory agencies, and public institutions. Although some of the world’s most prolific diseases are more complex than COVID-19 coronavirus, growing infrastructural and financial support are enabling scientists to make breakthroughs in diseases that seemed insurmountable only a decade ago in underserved regions around the world.
Journal Article
Development of cell and gene therapy (CGT) products is often challenged by the need to demonstrate product comparability following changes in the manufacturing process. Issues include limited process and product knowledge at different stages of product development compared to more conventional biotherapeutics, the complex mechanism of action, the limited and sometimes variable nature of the starting materials, and analytical methods which are often still in development during a comparability study.
Journal Article
Quality control (QC) is a fundamental aspect for assuring the safety and efficacy of medicinal products. Testing of drug substances (DSs) and final drug products (DPs) is performed at intermediate manufacturing stages to confirm that they meet established specifications as defined in a marketing authorization. This does not differ for advanced-therapy medicinal products (ATMPs).
Journal Article
Assay development doesn’t end with a validated analytical method. Changes are made as a biopharmaceutical product continues through development. Often that progress includes transfer from the original laboratory to another. Whether a project is outsourced or scaled up in house, analytical methods such as bioassays must be transferred to new laboratories, with different personnel and often different equipment setups.
Journal Article
A webinar hosted by Biopharma Excellence featured an in-depth discussion on the ways that updated guidelines, a reduction in clinical efficacy testing, and biomarker analyses can have on the efficiency of biosimilar development.