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March 20, 2023 53Biologics Administrador Comments: 0

53Biologics Awarded ISO 13485 Certification for Quality Management System

53Biologics, a leading biopharmaceutical contract development and manufacturing organization (CDMO), is proud to announce that it has been awarded ISO 13485 certification for its quality management system. This prestigious certification demonstrates the company’s commitment to quality and to meeting the highest international standards for medical devices.   ISO 13485 is an international standard that specifies requirements for a quality management system for organizations involved in...
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February 22, 2023 53Biologics Administrador Comments: 0

53Biologics expands its state-of-the-art facilities to better serve biopharma industry

The Spanish CDMO 53Biologics is operating in a new facility recently adquired at Boecillo Technological Park. Boecillo, Spain – 53Biologics, a leading CDMO for the biopharma industry, has recently expanded its facilities in the Boecillo Technology Park. This expansion was necessary to accommodate the company’s consistent growth and to better serve its clients. “Demand for our services has been rising every year, so we have been hiring additional staff and shortening turnaround times.&#...
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February 15, 2023 53Biologics Administrador Comments: 0

53Biologics will be attending the Festival of Biologics USA

The America’s most exiting biologics event is coming! We are going to be at the Festival of Biologics, a congress that reflects the importance of biologics’ value chain. It will take place the 20-23rd of March in San Diego. If you are interested in antibodies, immunotherapy and biosimilars, we are the CDMO you are looking for! Contact our Business Development manager Cristina Brugnolaro through LinkedIn if you want to schedule a meeting during the congress....
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Pharma future - PERTE Salud de Vanguardia
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January 11, 2023 53Biologics Administrador Comments: 0

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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53Biologics Christmas
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December 20, 2022 53Biologics Administrador Comments: 0

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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December 14, 2022 53Biologics Administrador Comments: 0

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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November 16, 2022 53Biologics Administrador Comments: 0

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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November 7, 2022 53Biologics Comments: 0

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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November 2, 2022 53Biologics Administrador Comments: 0

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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October 26, 2022 53Biologics Administrador Comments: 0

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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