The generation of a Research Cell Bank (RCB), Master Cell Bank (MCB) and Working Cell Bank (WCB) is critical for protein production, whether for therapeutic proteins, monoclonal antibodies, or enzymes. In this article, we explore the key differences between these cell banks, their characterization, and their role in GMP production. 1. Research Cell Bank The RCB is the first stage of cell banking, typically used during early process development and optimization. It consists of a small-scale froze...

In the biopharmaceutical industry, cost-efficiency is essential to ensure the viability of biotherapeutics and biologics. That is why, optimizing your production process is key to reduce costs while you are maintaining quality and regulatory compliance. This article explores practical strategies to lower costs in protein manufacturing, with insights into process optimization and innovative solutions. 1. Expression system selection Choosing the right system (e.g., E. coli, Pichia pastoris, or mam...

Biologics production requires adherence to stringent regulatory standards to ensure product safety, efficacy, and consistency. Global regulatory agencies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established Good Manufacturing Practices (GMP) guidelines to govern the manufacturing of these complex therapies. GMP regulations provide a framework for the entire production process, from cell line development  to final product release . These g...

Recombinant protein expression enables the production of biological therapies, vaccines, or ancillary reagents, among others. A critical decision in any project is the choice of the right host system, as each comes with advantages and disadvantages that can impact yield, quality, and cost. In this article, we explore the most commonly used host systems in recombinant protein production. Bacteria: A Versatile and Efficient Option Regarding bacterial hosts, we will analyze the two most commonly us...

Type 1 diabetes is a disease that prevents the body from producing insulin, the hormone responsible for regulating blood sugar levels. Without insulin, the body cannot properly use glucose, leading to toxic blood sugar levels and potentially fatal consequences. Today, people with diabetes can live normal lives thanks to insulin injections, but a century ago, the situation was vastly different. In the early 20th century, the only way to manage diabetes was through an extremely restrictive diet lo...

Choosing the right CDMO (Contract Development and Manufacturing Organization) is essential to ensure the success of your biopharmaceutical project. This decision can make all the difference between a successful market launch and a delayed project. Here is a guide with key aspects to consider, including how the right CDMO can make a difference. 1. Availability and Start Time Time is a critical factor in biopharmaceutical development. Therefore, a CDMO that can start working on your project withi...

This award acknowledges the company’s groundbreaking work in microbial expression systems and its ongoing commitment to delivering cutting-edge biotechnological solutions for the global market. 53Biologics, a Contract Development and Manufacturing Organization (CDMO) headquartered in Valladolid, Spain, has been awarded the prestigious Biotechforum Award for “Best Company in Biotechnology Innovation” during Farmaforum, Spain’s most prominent pharmaceutical and biotech industry eve...

We are thrilled to announce that 53Biologics has been recognized by Pharma Source as one of Europe’s leading Contract Development and Manufacturing Organizations (CDMOs) for biologics production. This prestigious recognition highlights our relentless commitment to delivering high-quality biologics manufacturing services and innovative solutions to the pharmaceutical and biotech sectors. A Milestone Achievement Being named as one of the top European CDMOs is a significant milestone in our journ...

We are excited and honored to announce that we have been nominated for the Farmaforum Awards in the category Biotechforum, Best Company in Biotechnological Innovation. This nomination is a testament to our team’s hard work, dedication, and innovative spirit in the field of biotechnology. At 53Biologics, we’ve always supported our clients with innovative solutions faclitiating their journey to market. This recognition validates our efforts and motivates us to continue striving for exc...

The first week of June, part of 53Biologics dedicated team completed our annual fire and emergency response training course. This crucial training ensures that our employees are well-prepared to handle any emergency situation, prioritizing safety and quick action. From fire prevention techniques to emergency evacuation procedures, our team is equipped with the knowledge and skills to maintain a safe working environment. This commitment to safety is a cornerstone of our operations, ensuring we ca...