53Biologics was established as a biotech company in 2017, a new business unit inside of the BDI biotech Group, to provides solution and services in the pharma and diagnostic sector.

53Biologics is a CDMO with extensive experience in decoding biologics overexpression providing services of cell line transformation, banking and characterization (cGMP if required), analytical development, process development (USP & DSP) and batches production.

Our mission is to provide services to different companies, from start-ups to large companies, as well as to other pharma CDMOs, to help their products to reach the market.

53Biologics works in a quick, proactive and efficient way, always ensuring very high-quality standards.

Our name

What do we have in common with an insect or a bacterium? The molecular instructions for life! or in other words…. DNA.

As you well know, DNA is a structure that encodes biological information. This pattern is “read” from the five-prime end (5′) to the three-prime end (3′), but for us, this way of reading is so much more than a simple transcription process, it is our beginning.

At 53Biologics we have embraced as our name, our philosophy and our meaning of life, because the decoding of any biological begins with its DNA.

Our Team

Experts in recombinant proteins services. We are an agile and versatile multidisciplinary team of almost 30 people including biologists, biotechnologists, chemical and process engineers with over 15 years of experience overexpressing proteins.

53Biologics works in a quick, proactive and efficient way, always ensuring very high-quality standards. Strong R&D team for both strain engineering and bioprocess development and scale-up with a proven track record to support new product development.

Speed up the Path to Manufacturing

53Biologics gathers years of experience in development, scale-up, validation and transfer of bioprocesses. It helps to give its clients a better understanding of the road map ahead up to product manufacturing. ​

53Biologics has a flat structure, customer-oriented of a small and reactive partner to reduce the development times.

Our Values

  • Open communication
  • Customer-focused

  • Commitment

  • Passion

  • Confidentiality

Quality Policy

It is widely considered that the essential factor for the success of a company is quality.

Therefore, the quality policy is based on a firm commitment with clients to meet their requirements and expectations. For this reason, 53Biologics has been working to guarantee and promote a culture of quality, by adopting the most demanding international quality controls.

53Biologics is ISO 9001:2015 certified and implementing ISO 13485:2016 and the cGMP (manufacture good practice)

good manufacture practice