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Updates
Insights, updates and perspectives from the 53Biologics team on biologics development and manufacturing.
Why GMP Readiness Starts During Drug Development, Not at Clinical Phase
Most biotech teams assume GMP readiness begins when a product enters clinical phases. In reality, the foundations of GMP are built much earlier, during drug development, often without being explicitly labeled as such. Drug Development…
How to Scale Manufacturing Without Losing Quality or Compliance
Scaling manufacturing is one of the most misunderstood transitions in biologics development. Many teams assume that if a process works at small scale, it will behave similarly at larger volumes. In reality, scale up in manufacturing is not…
53Biologics boosts its GMP biomanufacturing expansion with an investment led by Ren Life Sciences and supported by Inveready
VALLADOLID, MARCH 25, 2026 53Biologics, a biotechnology company specialising in the development and manufacturing of biological drugs, has announced the closing of a strategic financing round led by the specialist European private equity…
Understanding the Manufacturing Responsibilities for Drug Substances and Drug Products
Understanding the responsibilities involved in Drug Substance and Drug Product manufacturing is essential for making the right strategic decisions. Many biotech companies approaching clinical phases discover that the distinction between…
GMP Manufacturing Pitfalls That Delay Biologics Production (and How to Avoid Them)
GMP manufacturing pitfalls that delay biologics production can increase costs, disrupt clinical timelines, and compromise regulatory readiness if not addressed early. In biologics development, delays rarely come from a single dramatic…
Driving innovation: new automated small-volume fill & finish line
At 53Biologics, we continue to advance our commitment to innovation and operational excellence. We have done it with the implementation of a novel flexible and automated small-volume fill & finish line. This project has been funded by the…