A top priority for drug developers is to find outsourcing partners with experience in transferring and scaling their product formulation and processes from sending unit (SU) to commercial-scale receiving unit (RU) in compliance with regulatory agencies. Whether you are a new drug developer or a veteran, there are four key considerations you should consider when you search for a CDMO partner for a strong technology transfer performance. 1. Geography An understanding of the market landscape is n...

As the biopharmaceutical industry continues to evolve and in response to increased interest from global regulatory agencies, the Quality by Design (QbD) integrated and proactive approach to drug development and manufacturing is transforming key processes. QbD seeks to further reduce the risk associated with drug development and bring much-needed therapies to market quicker. As an example,  companies that implement QbD early can save money through increased product/process knowledge, less re-w...

A company’s strategy is crucial for determining future success, and therefore, it needs to constantly change in line with market dynamics. Today, mAbs represent the dominant product class within biopharmaceuticals, driven largely by the increasing prevalence of – and increasingly sophisticated approaches to treating – severe and complex diseases, including cancers. Additionally, in 2020, 55% of biologics reached the clinical stage (628 of 1133), with 426 products related to mAbs. According...

Getting to market first starts with cell banking as the foundation for your biologics production. Cell banks should be used when cell lines are used in the biologics production. Particularly in case that your protein of interest will follow clinical studies, regulatory agencies require cell bank manufacturers to guarantee continued stability and safety of cell lines producing biologics under cGMP. Why is cell banking important? Cell banking provides a characterized, common starting source for ea...

With increasingly specialized science and technology, keeping biologics and drug development and manufacturing in-house is not feasible. Selecting a Contract Development and Manufacturing Organization (CDMO) partner is more necessary than ever. But not every CDMO is the best choice for your company. Selecting a Contract Development and Manufacturing Organization partner impacts not only your current drug development but also other drugs you have in the pipeline. Therefore, it is of utmost im...

The Department of Chemical Vocational Training of IES Ramon y Cajal in Valladolid invited us to participate in the I Conference “Aprendiendo de las empresas”. Thanks to this event we could reach the classrooms and talk about what we do with the students. IES Ramon y Cajal, good teaching good future This high school center is part of the “Junta de Castilla y León” educational platform. Their philosophy is good teaching, good future and guided by this mantra, they recently inaugurat...

Since only a small proportion of biotherapeutics that enter clinical trials make it to reach the market, companies tend to have a large pipeline of candidates, like monoclonal antibodies (mAbs) or gene therapy. This implies that there are many processes that need to be developed at the same time. In addition, pressure from healthcare providers is driving the need to reduce the manufacturing costs. Therefore, upstream and downstream optimization is necessary. The Bioprocessing of Biologics like m...

The continuous emergence of SARS-CoV-2 variants has highlighted the global need to immunize the population. For this reason, the STABVAC4COV project aims to develop a vaccine against the Delta variant of SARS-CoV-2 that is more stable than the current ones and, consequently, easier to distribute. mRNA technology will be used for its development. In parallel, the proyect will work on the development of compounds, especially enzymes involved in the RNA synthesis process in vitro. With this kno...