0
  • No products in the cart.
Total:£0.00

22 Apr

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

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text css=""]The establishment and management of a comprehensive cell bank system is central to biologics and cell and gene therapy manufacturing. Yet, navigating the requirements, best practices, and regulatory expectations from research through to end-of-production can be complex....

22 Apr

Posted at 10:54h in Biopharmaceutical Resources, Cell & Gene Therapy Resources

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text css=""]In the complex and regulated world of biologics, potency assays are among the most critical tools used to ensure the quality, efficacy, and consistency of therapeutic products. Whether it’s for release testing, stability studies, or development milestones,...

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

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...

11 Oct

Posted at 15:27h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Pharmaceutical Regulatory Affairs Resources

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...

31 Aug

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

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...

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.   Why Can't We Develop Products as Fast as...

12 Jan

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

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text css=""] In the fast-paced world of biologics development, analytical assays play a pivotal role in ensuring product safety, efficacy, and regulatory compliance. Yet, despite technological advances, some assays continue to pose significant challenges across the product lifecycle. In...

29 Oct

Posted at 15:44h in Biopharmaceutical Resources, Cell & Gene Therapy Resources

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...

18 Aug

Posted at 14:59h in Cell & Gene Therapy Resources

Advanced Therapy Medicinal Products (ATMPs) represent a cutting-edge category of treatments in the pharmaceutical industry, designed to address unmet medical needs, particularly for complex and chronic conditions. These therapies fall under four broad categories: gene therapies, somatic-cell therapies, tissue-engineered products, and combined ATMPs. This article...

30 May

Posted at 10:29h in Cell & Gene Therapy Resources

Getting a cell and gene therapy developed, manufactured, and approved on the market is challenging. There are numerous hurdles to overcome such as supply chain issues, aseptic working, patient access, efficacy and safety.  Below are short interviews with a range of Educo Life Science Trainers who...

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...