We are excited to share that Francisco Reyes Sosa will be representing 53Biologics at the BIO International Convention in Boston, USA, this June. BIO is one of the most important gatherings in the biopharmaceutical industry, bringing together thousands of innovators, partners, and experts from across the globe to accelerate the future of biotechnology.  At 53Biologics, we specialized in decoding biologics production, from DNA to proteins.  As a flexible and experienced CDMO, we specialize in t...

In an increasingly competitive and regulated biopharmaceutical landscape, the role of a Contract Development and Manufacturing Organization (CDMO) has become a key pillar in accelerating innovation and ensuring the quality of biologics development. But what exactly is the value that a CDMO brings to the industry? And why is its role becoming more strategic? The Growing Complexity of Biopharmaceutical Development The development of biologics is far more complex than traditional pharmaceuticals. B...

Scaling up protein manufacturing is a complex and critical step in the biopharmaceutical industry. Unlike small-scale production, large-scale manufacturing presents unique challenges related to maintaining product consistency, optimizing yields, and ensuring compliance with stringent GMP regulations. In this article, we explore the essential factors for successful large-scale protein manufacturing, emphasizing process robustness, efficiency, and regulatory alignment. 1. Process Development and S...

Plasmid DNA (pDNA) plays a crucial role in modern biotechnology and biopharmaceuticals. From gene therapy to vaccine development, pDNA is a fundamental component driving advancements in medicine. Ensuring high-quality pDNA manufacturing is critical for achieving consistent and reliable results across various applications. 1. Gene Therapy One of the most significant applications of plasmid DNA is in gene therapy, where it serves as a vehicle to introduce therapeutic genes into patient cells. Gene...

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...