Marketing authorisation is a critical step for any medicinal product entering the European market. Unlike the US, where the Food and Drug Administration (FDA) handles approvals, Europe offers several complex regulatory pathways. This article explores the various marketing authorisation routes available in the European Economic...

CMC, Chemistry, Manufacturing and Controls (CMC) refers to all the elements involved in producing pharmaceutical, biologic, or cell & gene products. CMC activities commence from product development and progress through pre-clinical, clinical, and eventual marketing. Various skilled professionals work in CMC to develop and manufacture...

Combination products, which integrate pharmaceutical and medical device components, are an innovative and expanding sector in medical solutions. This article, based on insights from expert Richard Young, covers the unique regulatory challenges faced by manufacturers and developers working with these products, especially in Europe and...

Chemistry, Manufacturing, and Controls (CMC) form a critical component of pharmaceutical drug development. This article delves into the complexities of CMC, discussing its role, processes, and regulatory aspects. This knowledge is essential for professionals involved in drug development, especially in navigating the intricacies of bringing...

Biotech startups face numerous hurdles in Chemistry, Manufacturing, and Controls (CMC) development. From regulatory requirements to balancing costs and timelines, managing these complex processes is crucial for survival in the highly competitive pharmaceutical industry. In this article, we explore key CMC challenges biotech startups face...

Continuous biomanufacturing has rapidly become a vital strategy for pharmaceutical and biotech companies, offering substantial benefits such as cost reduction, faster production timelines, and enhanced process efficiency. Initially introduced in the 1980s, the technology has significantly evolved, now being applied to both upstream and downstream...

A greater number of cell and gene therapies are entering development, often with innovative modalities. One of the biggest challenges is within bioanalytics when understanding biodistribution and pharmacokinetics of cell and gene therapies. As discussed below, a new way of thinking is often required to...

A greater number of cell and gene therapies are entering development, often with innovative modalities. One of the biggest challenges during CMC development is analytics. Analytics of biologics are complex enough, but with cell and gene therapies a new range of analytical issues arise.  We interviewed...

We interviewed Educo Life Sciences trainer Nadine Ritter to find out why drugs cannot be developed as quick as the COVID vaccine. Nadine explains all the factors that led to the fastest development of a drug in history.   Why Can't We Develop Products as Fast as...

We interviewed Educo Life Sciences trainer Nadine Ritter to discuss the most challenging analytical assays for biological products. In the interview Nadine discusses the issues scientists face with Host Cell Protein assays. She also discusses the challenges of potency assays and how early decisions can...

RNA therapeutics have emerged as a pivotal innovation in modern medicine, offering targeted treatments for a range of genetic diseases. Unlike traditional therapies, RNA-based approaches aim to manipulate gene expression or replace faulty proteins, thus providing a powerful tool for combating complex diseases. This article...

We interviewed Educo Life Sciences trainer John Faulkes to discuss a career in pharmaceuticals for those who are not scientists. We often get asked the best routes to get into the pharmaceutical industry and John highlights alternative routes that are perfect for non-scientists. In this...

We interviewed Educo Life Sciences Trainer John Faulkes to get his views on the top three trends in the pharmaceutical industry. John highlights some interesting trends such as decentralised clinical trials, digitalisation & AI and agile working. You can watch or read the video below.   Watch...

We interviewed Educo Life Sciences trainer Margit Holzer to get her views on a career in the biopharmaceutical industry, specifically manufacturing. Margit discusses her career experiences and provides some advice for those starting out in biotech. She also discusses future trends such as cell and...