Changing CDMO late in development is not always a warning sign. Sometimes it is the right decision. But it should be managed as a strategic move, not an administrative transfer.
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When companies evaluate GMP recombinant protein manufacturing, discussions often revolve around timelines, batch size or price per gram.
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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...
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Effective scale up in manufacturing requires building predictive understanding, not just replicating conditions. At 53Biologics, their Process Development Services focus on identifying scale-dependent...
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Biotechnology company 53Biologics, specialized in the development and manufacturing of biologic drugs, has announced the closing of a strategic funding round led by European private equity firm Ren Li...
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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 d...
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GMP manufacturing pitfalls that delay biologics production can increase costs, disrupt clinical timelines, and compromise regulatory readiness if not addressed early.
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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 a...
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Process validation ensures manufacturing consistency, reduces deviations, prevents rework, improves resource utilization, and facilitates production scale-up. As a direct result, it accelerates time t...
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53Biologics ha sido distinguida hoy con el Premio Pyme del Año 2025 de Valladolid, un reconocimiento otorgado por Banco Santander y la Cámara de Comercio de Valladolid, en colaboración con la Cáma...
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Biologics development is complex. Each project involves multiple stakeholders, tight timelines and strict regulatory standards. For companies working with a Contract Development and Manufacturing Orga...
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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 i...
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La mejor actitud que podemos adoptar es la de trat...
The research team observed changes in head circumf...
AtCDF3 gene induced greater production of sugars a...
En nuestro post hablamos sobre este interesante tipo de célula del...
Curapath is pleased to acknowledge the significant progress achieved b...
