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23 Jul

Posted at 13:02h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Pharmaceutical Regulatory Affairs Resources

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...

14 Jun

Posted at 11:00h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Medical Device & IVD Resources, Pharmaceutical Regulatory Affairs Resources

A combination product refers to a medical device that contains an element of a pharmaceutical. Recognising this and understanding which regulations need to be met is essential to ensure the successful marketing of your product. Educo Life Sciences caught up with Richard Young, who explained some...

31 Aug

Posted at 12:35h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Pharmaceutical Regulatory Affairs Resources

We interviewed Educo Life Sciences trainer Raz who teaches on the CMC Essentials course. During our discussion, we delved into the significant challenges that small biotech start-ups encounter when embarking on CMC development. Importantly, Raz also offered valuable insights into potential solutions to overcome these...

14 Mar

Posted at 15:13h in Biopharmaceutical Resources, Cell & Gene Therapy Resources

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...

12 Jan

Posted at 14:16h in Biopharmaceutical Resources, Cell & Gene Therapy Resources

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...

12 Jan

Posted at 14:12h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Medical Device & IVD Resources, Pharmaceutical Regulatory Affairs Resources

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. Watch the full interview below: [embed]https://youtu.be/-4B6qiVuM9Y[/embed]   Why Can't We Develop...

12 Jan

Posted at 14:16h in Biopharmaceutical Resources, Cell & Gene Therapy Resources

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...

23 Jan

Posted at 14:13h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Pharmaceutical Regulatory Affairs Resources

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...

23 Jan

Posted at 12:06h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Pharmaceutical Regulatory Affairs Resources

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...

07 Jun

Posted at 09:49h in Biopharmaceutical Resources, Cell & Gene Therapy Resources

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...