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April 28, 2023 Patricia De La Madrid Comments: 0

Introducing 53Biologics’ New 2000L GMP Production Line for Biologics

53Biologics, a leading CDMO specializing in biologics production and cGMP manufacturing for biological products, is pleased to announce the opening of a new GMP production line for microbial. The new production line boasts a 2000L reactor, making it one of the largest of its kind in the world. This new addition to 53Biologics’s manufacturing facility allow them to meet the growing demand for microbial-based products and serve more clients across the globe. In addition to the 2000L reactor,...
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April 4, 2023 Patricia De La Madrid Comments: 0

Happy Easter from the 53Biologics team!

On behalf of the entire team at 53Biologics, we would like to wish all our clients and their loved ones a happy and joyous Easter holiday. May this special occasion bring you lots of happiness and laughter. As a biopharma CDMO dedicated to improving the lives of people around the world, we understand the importance of taking time to celebrate and appreciate the things that matter most in life. We hope that this Easter holiday provides you with a well-deserved break and an opportunity to recharge...
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March 28, 2023 Patricia De La Madrid Comments: 0

The role of pDNA in biotech industry

When plasmid DNA was discovered, its function was not even known. Today its importance goes beyond microbial evolution, as it plays a fundamental role in the production of vaccines, gene therapies and cell therapies.   What is plasmid DNA? A plasmid is a very special small genetic element. It consists of a circular double-stranded DNA present in many bacterial species capable of self-replicating independently of chromosomal DNA. This capacity already gives it the category of “special&...
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March 20, 2023 Patricia De La Madrid 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 Patricia De La Madrid 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 Patricia De La Madrid 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 Patricia De La Madrid 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 Patricia De La Madrid 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 Patricia De La Madrid 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 Patricia De La Madrid 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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