Biologics development is complex. Each project involves multiple stakeholders, tight timelines and strict regulatory standards. For companies working with a Contract Development and Manufacturing Organization (CDMO), strong project management is the key to transform complexity into clarity. Without it, delays, cost overruns and miscommunication can easily derail progress. 1. Why Project Management Matters A biologics program spans many stages: cell line development, process optimization, scale-u...

53Biologics has been featured in the latest edition of APTE Technonews (Issue 91), the magazine of the Spanish Association of Science and Technology Parks. The article highlights our contribution to innovation in RNA enzyme manufacturing. This is a cornerstone technology enabling mRNA vaccines, gene therapy and next-generation RNA-based treatments. The challenge of RNA enzyme manufacturing RNA-based therapeutics rely on high-performance enzymes such as RNA polymerase, essential for accurate RNA...

In biologics manufacturing, upstream production often captures much of the spotlight. Fermentation, cell culture and expression systems are frequently discussed as the heart of drug development. Yet, for many companies, the true bottleneck lies downstream, in purification. Chromatography and filtration steps that work well at bench scale can become major hurdles when scaled to industrial volumes. At 53Biologics, we understand that downstream processing is where efficiency, cost control and produ...

When it comes to biologics, quality is not just important, it is everything. Unlike small molecules, biologics are produced by living systems, which makes them more complex, more variable and more sensitive to manufacturing conditions. To ensure safety and efficacy, regulators require companies to define and monitor Critical Quality Attributes (CQAs) throughout development and production. At 53Biologics, we see CQAs as the blueprint of product quality. By identifying them early and controlling t...

At 53Biologics, we believe that cell banking is the cornerstone of biologics manufacturing. It is the foundation on which large-scale production is built, ensuring that every batch is consistent, safe and effective. Behind every successful biologic drug lies a reliable cell bank. Whether producing therapeutic proteins, monoclonal antibodies, or enzymes, biologics manufacturing depends on stable, well-characterized cell lines. Without them, reproducibility and regulatory compliance would be impos...

Plasmid DNA (pDNA) has become the essential starting material in modern gene therapy. Without it, producing reliable viral vectors would not be possible. As the field of gene therapy expands, ensuring that pDNA is manufactured at the right scale, purity, and regulatory standard is becoming one of the defining challenges for biotech companies. At 53Biologics, we see plasmid DNA as much more than a raw material: it is the backbone of the entire gene therapy ecosystem. Understanding its role, the c...

Artificial intelligence (AI) has already become part of everyday life, and it is beginning to reshape the biopharma industry. Its potential is undeniable: accelerating drug discovery, optimizing manufacturing, and bringing therapies to patients faster. Yet readiness remains low—only 14% of large biopharma companies and 3% of smaller ones are prepared to adopt AI, according to Benchling. Artificial Intelligence Roadblocks in Pharma For big pharma, the challenge is complexity. Years of using mul...

Scaling up biologics manufacturing from lab-scale to GMP production is a critical step that often presents unexpected challenges. While early-stage processes may work efficiently on a small scale, not all bioprocesses translate smoothly to larger volumes or industrial environments. Understanding these obstacles is key for successful technology transfer and commercialization. Common Challenges in Scaling Biologics Manufacturing 1. Biological Complexity and Variability Biologics such as recombinan...

The biopharmaceutical industry is rapidly advancing, with GMP biologics manufacturing at the heart of this transformation. With rising demand for scalable biologics, CDMOs like 53Biologics must continuously adapt to client and regulatory expectations. In 2025, 53Biologics stands out by pairing robust GMP manufacturing with agile, tailored solutions for microbial and mammalian biologics production. Meeting the Rising Demand for Microbial Biologics Microbial expression systems such as E. coli and...

Selecting the optimal cell line is a critical early decision in the development of any biologic drug. It can impact everything from expression yields and product quality to regulatory timelines and commercial strategy. One key consideration for many developers is whether to use a licensed or unlicensed cell line, and the right answer depends on the specific goals, timeline, and product profile. At 53Biologics, we do not offer proprietary strains or cell lines. Instead, we prioritize flexibility....