Flexible, agile and customer-focused. This is 53Biologics

Given the intricate and unpredictable nature of pharmaceutical development, agility and flexibility have become indispensable elements for drug developers seeking partnerships with CDMOs. In this article, we delve into the distinctive value proposition of  53Biologics’ services and how these solutions are tailored to address the specific requirements of its clients.

“Our clients are the innovators who develop treatments that are currently not available. We are committed to supporting those innovators by taking their molecule through the development journey successfully from the beginning. We care about and consider the business achievement they want when working with us.”

  • Pablo Gutierrez, CEO of 53Biologics

Agile Solutions

53Biologics possesses the capability to react promptly and in a planned, risk-based manner, ensuring the delivery of new medicines within the most efficient timelines, regardless of the challenges encountered during development. The company’s flexibility allows it to adapt and alter strategies based on what is optimal for the molecule, enabling it to overcome unforeseen obstacles and maximize the probability of success.

Our team is dedicated to assisting pharmaceutical and biotechnology companies in achieving their development milestones, ensuring that programs run smoothly and timelines are met. By leveraging scientific and regulatory expertise, along with dedicated teamwork and meticulous planning, the company continuously adapts to innovation and employs advanced technology to assess risks and manage challenges without compromising on quality.

Flexible Solutions

For every single project, our experts and scientists from each field come together to understand the unique characteristics of a client’s protein  of interest. Based on our past development experience and after an in-depth analysis, we draw up a personalized solution depending on the client’s needs. During development, seamless communication and collaboration across teams has enabled us to promptly respond when any issue arises.

53Biologics provides a seamless transition from development to clinical manufacturing and beyond, leveraging its track record of success in the contract manufacturing space. The company offers a large capacity with bioreactors of multiple scales, ranging from 1 liters through 2,000 liters, along with GMP capabilities, global standard in tech transfer and raw materials procurement. With vast experience in facility operations and regulatory inspections, 53Biologics ensures a smooth journey from development to commercialization.

Client-Centric Approach

“As a trusted CDMO partner, we do our best to address continuously changing client needs during the course of development without any road bumps while providing full transparency to the clients along the way. Clients want us to step up in every aspect; they value our opinion in decision making when carrying out the program.”

  • Elena Hernández, Project Management Director

In an increasingly competitive market, a robust development plan that identifies potential risks while prioritizing speed and quality from the initial stages is essential. 53Biologics continues to optimize processes, train personnel and expand its capacity, with client satisfaction as its utmost priority.

The company recognizes that each recombinant protein is unique, and its dedicated team provides meticulous support at every stage of the journey to realize its full potential. 53Biologics is committed to delivering on its promises to clients, ensuring the success of their programs and ultimately, helping patients with unmet medical needs.

If you are a biotech seeking to outsource your project from cell line development to IND, 53Biologics offers experience and innovative solutions tailored to meet your needs.


About 53Biologics:

53Biologics is a CDMO with specialized in biologics production. It is a leading biopharma company providing services from preclinical and clinical development to GMP manufacturing, supporting our clients in getting their biological products to market as quickly as possible.

For more information contact Patricia De La Madrid, Marketing & Business Development Manager at 53Biologics through this email: pdelamadrid@53biologics.com

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