The cell line development facility includes molecular and cell biology laboratories for cloning and expression capabilities, to develop biosimilar cell lines across different microbial and mammalian platforms.
The advanced process sciences laboratories enable scientists to develop phase appropriate, high quality, manufacturing-friendly processes. The cell culture, downstream purification and formulation development teams have scientists and engineers working together to make efficient technologies that ensure production of high-quality drugs.
The drug product development team has established technologies to develop both liquid and lyophilised presentations for both intravenous and sub-cutaneous delivery for patients. Biocon Biologics’ extensive experience in development of suspension formulations for recombinant human insulin and insulin analogues, puts this team in a unique position in the Biosimilars development space. Our focus on the development of high concentration liquid formulations has facilitated Biocon Biologics to manufacture the next generation biosimilar monoclonal antibodies.
Biologics characterisation facility allows for intricate structure function analysis of protein therapeutics. This enables the efficient predictive analysis on the risk to patient safety and efficacy. Biocon Biologics continues to invest aggressively in these facilities to ensure that the most sensitive techniques are used to understand the qualitative attributes of the biosimilar drugs.
Development and validation of the bioanalytical assessment platforms that adhere to global regulatory requirements allow for sensitive readouts for drug pharmacokinetics and immunogenicity in biosimilar clinical trials.
Our present focus is on developing sensitive analytical methods to quantitate the pharmacodynamic and response biomarkers in clinical samples. This effort is aimed to understand whether surrogate endpoints can be used to moderate clinical trial timelines for establishing biosimilarity.
Data analytics capabilities have allowed the enhancement of development functions and bring operational efficiencies into drug development.