53Biologics

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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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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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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How does protein expression work?

The central dogma in molecular biology is DNA→RNA→Protein.   To synthesize a particular protein DNA must first be transcribed into messenger RNA (mRNA). mRNA can then be translated at the ribosome into a polypeptide, an aminoacids chain that make up the primary structure of proteins. Most proteins are then modified via an array of post-translational modifications including protein folding, formation of disulfide bridges, glycosylation and acetylation to create functional, stable proteins...
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Biopharmaceutical companies: 4 Factors to Consider for the selection of your Biologics CDMO Partner

As the number of therapeutic molecules in development has increased during the last years,   the number of contract development and manufacturing organizations (CDMOs) has also significantly increased. With more CDMOs to choose from, pharmaceutical companies must prioritize CDMO selection criteria to find the right partner for their new drug development project.  Developing a new drug takes time—an average of 10 to 12 years—and can cost upward of $5.5 billion dollars and considering that...
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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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Which Are Better? Biologics or Small Molecule Drugs?

So to decide which is the best biologics or small molecule drugs, we have to consider many factors. But let´s start from the beginning.  What Is a Small Molecule Drug?  Small molecule drugs are typically either synthesized from or meant to replicate natural compounds produced by plants, fungi, and bacteria.  A small molecule drug uses biochemical processes to prevent or treat disease. They are highly effective allosteric modifiers and enzyme inhibitors, and they are used to target extracellu...
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