Capabilities

Increasing capital efficiency, mitigating development risk whilst being able to generate robust, well documented and traceable data, are key factors for being able to create value on a platform. This can be partnered not only to mitigate risk, but also to develop assets that can be later translated into clinical candidates, in order to build long-term sustainability and value.  At Biotecnol, the in-house versus outsourced capabilities are well balanced with the aim to exploit a core business model which not only allows Biotecnol to develop its own internal pipeline, but also to partner the development of Tribody products with third parties.

Biotecnol routinely performs various development activities according to its internal Standard Operational Procedures (SOPs) and Quality Systems: 

  • Isolation of antibody sequences identified from various sources.

  • Cloning of antibody sequences into Fab, scFv, Tribody, IgG and others.

  • Transient expression, purification and evaluation of yields.

  • Characterization of purity, stability and binding affinity.

  • Re-engineering of non-binding domains to improve yields and stability.

  • Evaluation of activity in vitro (T-cell killing and T-cell proliferation). 

All required animals studies are carried out externally, according to current regulatory requirements. 

Concerning the development of each Tribody manufacturing process, Biotecnol has a long standing track-record in process development and technology transfer for the generation of clinical trial grade material. These capabilities include:

  • Stable cell line development

  • Cell culture (upstream processing) and scale up to 20 litres

  • Development of analytical methods

  • Downstream processing

  • Formulation and stability studies

  • Long standing track-record in technology transfer to contract manufactures (CMOs) 

Biotecnol believes that a tight control and a sound and growing understanding of its own Tribody platform is key for a continuous development of an efficient and consistent development path, right from Lead Tribody Identification to Investigational New Drug (IND) filing. Hence, enabling the production of Tribody Drug Substance for its own clinical research in a robust, scalable and reproducible manner.