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June 13, 2022 53Biologics Comments: 0

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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June 6, 2022 53Biologics Comments: 0

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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May 24, 2022 53Biologics Comments: 0

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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May 16, 2022 53Biologics Comments: 0

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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May 13, 2022 53Biologics Comments: 0

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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May 9, 2022 53Biologics Comments: 0

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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May 2, 2022 53Biologics Comments: 0

5 Biotech Companies Join Forces to Develop a Thermostable SARS-CoV-2 Delta Variant Vaccine

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...
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April 20, 2022 53Biologics Comments: 0

Different expression systems that 53Biologics use

The central dogma of biology is based on the sequence of DNA to RNA to Protein. To create a specific protein, DNA must initially be transcribed into mRNA, which is then translated into a polypeptide chain, forming the primary structure of the protein. Subsequently, the majority of proteins are modified via an array of post-translational modifications, including protein folding, formation of disulfide bridges, glycosylation, and acetylation. The process of synthesizing proteins from mRNA and addi...
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April 6, 2022 53Biologics Comments: 0

Biopharmaceutical companies: 4 Factors to Consider for the selection of your Biologics CDMO Partner

In recent years, there has been a notable increase in the number of therapeutic molecules. This increase has led to a corresponding increase in the number of CDMOs like us. With so many CDMOs to choose from, it is crucial for biopharmaceutical companies to carefully consider their selection criteria.   Finding the Right Biologics CDMO Partner  To ensure that you select the right biologics CDMO partner for your project, it’s important to ask yourself: Will you be working with the CDMO...
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March 24, 2022 53Biologics Comments: 0

Oligofastx project, development of RNA-based therapeutics

53Biologics participates in the OLIGOFASTX project. This project aims to create a comprehensive platform to facilitate and contribute to the accelerated development of oligonucleotide-based therapies in Spain. OLIGOFASTX is a multidisciplinary consortium led by Sylentis (PharmaMar Group) and in which other companies such as Nanovex Biotechnologies, ARTHEx Biotech, Aptus Data Labs, aptaTargets and Nostrum Biodiscovery participate in addition to 53Biologics. 53Biologics participates in th...
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