Changing CDMO Late in Development: What Biologics Teams Should Know

por 53Biologics

4 days ago
CDMO

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.

Recombinant Protein Production Under GMP: Key Decisions That Define Success

por 53Biologics

2 months ago
GMP Manufacturing, Recombinant Protein

When companies evaluate GMP recombinant protein manufacturing, discussions often revolve around timelines, batch size or price per gram.

Why GMP Readiness Starts During Drug Development, Not at Clinical Phase

por 53Biologics

3 months ago
GMP, Drug Development

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...

How to Scale Manufacturing Without Losing Quality or Compliance

por 53Biologics

3 months ago
GMP manufacturing

Effective scale up in manufacturing requires building predictive understanding, not just replicating conditions. At 53Biologics, their Process Development Services focus on identifying scale-dependent...

53Biologics impulsa su expansión en biomanufactura GMP con una inversión liderada por Ren Life Sciences y el apoyo de Inveready

por 53Biologics

3 months ago
53Biologics, Ren Life Sciences

53Biologics, compañía biotecnológica especializada en el desarrollo y fabricación de fármacos biológicos, ha anunciado el cierre de una ronda de financiación estratégica liderada por el privat...

Understanding the Manufacturing Responsibilities for Drug Substances and Drug Products

por 53Biologics

3 months ago
Drug Substances, 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 d...

GMP Manufacturing Pitfalls That Delay Biologics Production (and How to Avoid Them)

por 53Biologics

4 months ago
GMP manufacturing, Biologics Production

GMP manufacturing pitfalls that delay biologics production can increase costs, disrupt clinical timelines, and compromise regulatory readiness if not addressed early.

GMP Manufacturing with a Biologics CDMO: How to Make the Right Decision at a Critical Stage

por 53Biologics

5 months ago
GMP Manufacturing, CDMO

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...

Process Validation: The Hidden Key to Operational Excellence in Industry

por 53Biologics

5 months ago
Process Validation

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...

53Biologics, galardonada con el premio pyme del año 2025 de Valladolid

por 53Biologics

7 months ago
Premio Pyme del Año 2025 de Valladolid, 53Biologics

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...

Project Management in Biologics Development: Keys to Successful CDMO Collaboration

por 53Biologics

8 months ago
Biologics development, Contract Development and Manufacturing Organization (CDMO)

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...

53Biologics featured in APTE Technonews for its innovation in RNA enzyme production

por 53Biologics

8 months ago
RNA enzyme production, APTE Technonews, 53Biologics

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...