The pharmaceutical industry is evolving and 53Biologics is changing in line. PERTE Salud de Vanguardia

The biotech and biopharma sectors contribute to saving lives and improve people’s well-being. It also has a very large economic impact all over the world, but it is necessary to improve and optimize the value chain of the pharmaceutical industry in order to keep improving people’s health. In other words, the industrial transformation of the pharmaceutical and medical device industries is very needed. The Spanish Ministry of Industry, Trade, and Tourism launched a grant called “PERT...
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Merry Christmas!

Merry Christmas from our 53Biologics family to yours! On this joyful season, we wish you and your family health, happiness, peace and prosperity in the coming year 2023....
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Optimizing Plasmid DNA Manufacturing for Commercial Success

Plasmid DNA development requires great expertise and experience. Selecting a supplier with the quality assurance protocols and Good Manufacturing Practices (GMPs) in place, will prevent you from delays. Also the right supplier will secure the right plasmid for your project in case you don’t’t have one yet.   In this article we are going to speak about some considerations that you should take into account, when you contract pDNA manufacturing service with a CDMO.    Consideration f...
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Ensuring a Consistent, High-Quality Biologic Drug Process Development 

The development process for a biologic is generally divided into cell line development, upstream and downstream development, manufacturing, and formulation development, where each development process holds its own purpose along a biologic’s journey to commercialization.   In this article we are going to answer some questions related with drug product process development challenges, risks and how to mitigate them, the difference between innovator and biosimilar drug product process development...
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How to increase unstable protein expression in E. coli

Recombinant protein expression and purification for therapeutic development or for in vitro studies can sometimes be a real challenge, because it requires huge investments in both time and cost in order to obtain high yields. The objective of this article is to give you a simple guide to easily establish optimal conditions for recombinant protein expression and production in E. Coli, which is the most widely used protein production system, of problematic unstable proteins of interest...
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Characterization and Validation for Biologics

Monoclonal antibodies and next-generation therapeutics need a more complex manufacturing process than a simple enzyme. For those molecules you need to assure their quality attributes and safety profile. In this article, we are going to explain how this validation process is done.    Understanding Process Risks  Even during the early drug discovery process, there are valuable opportunities to simplify the path to commercialization.  At this stage, multiple candidate molecules may be screene...
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Upstream Optimization for Plasmid DNA Manufacturing

Plasmid DNA manufacturing is increasingly needed. The pDNA-based cell and gene therapies treatments emerging in both industry and academia are growing. The need for novel treatment options to combat cancer, metabolic disorders and other infectious diseases is increasing on a global scale.   In this article, we will analyze the scalable process workflow solutions available for plasmid DNA manufacturing, from initial R&D investment to clinical testing, and commercialization. We will focus on...
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CMC Strategy for mRNA Manufacturing 

There is no question that mRNA mannufacturing is not easy. Besides testing their safety and efficacy, biopharmaceutical companies must also design a protocol for scaling and manufacturing the drug for regulatory approval and commercial use. This creates an immense pressure to expeditiously develop streamlined chemistry, manufacturing and control (CMC) strategies.  That is why in this article we will explain what a CMC strategy is and the challenges in the mRNA manufacturing.   What is CMC Deve...
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Project Engineer

We need to incorporate to our team a Project Engineer to supervise the design and execution of the company’s GMP plant expansion. Your daily work will focus on: Providing engineering support to design the different systems of a biopharmaceutical facility and achieve the project objectives in accordance with user requirements, pharmaceutical regulations and safety and environment. Responsabilities: Project Engineering: generate technical documents to deliver to the client: P&Ids, list...
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How to Improve Efficiency in Biopharmaceutical Process Development 

Process development landscape is changing and facing new challenges. Nowadays, time to clinic and time to market are becoming more important than ever for developers and manufacturers of biopharmaceuticals.   Although historically, the development timeline for a pharmaceutical drug has been 8 to 10 years, today with the use of expedited programs, such as fast track approval and breakthrough drug designation, has made the development time shrink.   In this article, we will speak about some in...
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