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.

Decoding the Protein Overexpression

DNA is ‘read’ in a specific way, like letters and words are read to from left to right to reproduce a message, the encoded information is translated in one direction. This reading frame, from the five-prime end (5’) to the three-prima end (3’) is in the genesis and the sense of life for 53Biologics. The initial designations refer to the number of carbon atom in a deoxyribose molecule to which a phosphate group bonds. But for 53Biologics is the way to translate, from a DNA to a protein, from just encoded information to a reality.

The 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.

Y/Our Project

53Biologics boost its client internal R&D, ensuring open communication and confidentiality to integrate both teams. A close contact with regular follow-ups where 53Biologics’ project managers would gather and communicate all the results obtained and discuss the next steps of the project.

53Biologics cares about the success of your projects as if they were our own. No matter the size of the project or the complexity of the challenge, 53Biologics will find and execute the precise solution to hit your target.

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