Clinical Manufacturing – How It Works

The drug development process includes these five stages: Discovery and Development Preclinical Research Clinical Research Regulatory Agency Review Regulatory Agency Post-Market Safety Monitoring Clinical research is the third stage of the drug development process and drugs that are being tested and researched in this stage of the process are not usually manufactured the same way or in the same facilities as drugs that are in commercial production. In this article, we’ll discuss the basics of c...
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53Biologics Digital Transformation

In a groundbreaking initiative, we’re embarking on the digitalization of our entire production process for biological products. By harnessing the power of data analytics and automation, we aim to enhance our decision-making capabilities, optimize manufacturing processes, and elevate the quality of our end products. This project represents a significant step forward in our commitment to innovation and ensuring excellence in every aspect of our operations. Stay tuned for updates as we propel...
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Top Considerations for Tech Transfer Performance

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...
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Quality By Design in Biologic Drug Development

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...
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Monoclonal Antibody Manufacturing in Biopharma Companies

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...
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Revolutionizing mRNA Vaccine Production: Our Commitment

In response to the urgent need for increased vaccine manufacturing capacity amidst the COVID-19 pandemic, we are proud to announce our latest project: the development of a new industrial production process for ARNm synthesis enzymes. Supported by the ERDF of the European Union and the Junta de Castilla y León, this initiative aims to address the critical shortage of vaccine supplies by enhancing the efficiency and scalability of production. By leveraging cutting-edge technology and strategic pa...
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What is the Difference Between Master Cell Bank and Working Cell Bank?

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...
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Pitfalls to Avoid When You are Seeking a CDMO

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...
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53Biologics Reach the Classroom Thanks to “Aprendiendo de las Empresas”

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...
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How USP and DSP Optimization Can Help Reduce Inefficiencies and Cost?

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...
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