Home › Updates
Updates
Insights, updates and perspectives from the 53Biologics team on biologics development and manufacturing.
From Development to GMP Manufacturing: When Should You Engage a CDMO?
In biologics development, timing is everything. Engaging a CDMO too late can lead to delays, regulatory gaps, and costly process redesigns. Engaging too early, without a clear development strategy, can slow momentum and inflate budgets. So…
GMP Manufacturing with a Biologics CDMO: How to Make the Right Decision at a Critical Stage
Reaching the point where GMP manufacturing becomes a real requirement is a defining milestone for any biologics program. At this stage, development decisions are no longer theoretical. They directly affect regulatory outcomes, clinical…
Process Validation: The Hidden Key to Operational Excellence in Industry
Process validation ensures manufacturing consistency, reduces deviations, prevents rework, improves resource utilization, and facilitates production scale-up. As a direct result, it accelerates time to market. For many years, process…
53Biologics, Valladolid SME of the Year 2025
The jury, made up of representatives from the Valladolid Chamber of Commerce, the Spanish Chamber of Commerce, Banco Santander, the Provincial Council of Valladolid and El Norte de Castilla, has recognised 53Biologics’ achievements in job…
Project Management in Biologics Development: Keys to Successful CDMO Collaboration
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…
53Biologics featured in APTE Technonews for its innovation in RNA enzyme production
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…