Research and Development - Principal domains

Enabling Technology
The R&D matrix enables excellence in our platform technologies spanning,

1. Process and Product Development

Expression Systems: To enable a robust product portfolio, we have capabilities and expertise in an array of expression platforms that include microbial and mammalian systems. Biocon's Pichia pastoris platform for expression of recombinant protein is our proprietary technology, which is applied in the rh-insulin and insulin analog product lines alongside the bacterial host system that is utilized for numerous small molecule APIs and peptides. Meanwhile, our reliable and scalable mammalian CHO and NSO cell-based expression platforms have also been delivering novel and biosimilar monoclonal antibodies.

Process Sciences: Our strong foundation in process sciences is key to our ability to develop biologics with economical scalability and high productivity coupled with high quality. The upstream processes, involving fermentation technologies and downstream processes for protein purification to develop bulk drug substance, have been established for more than a decade. To prepare for the next decade of exponential growth, we are working on improving process efficiencies through novel approaches such as flexible and continuous manufacturing. We have collaborated with leading academic institutions such as the Indian Institutes of Technology (IITs) and National Institute of Pharmaceutical Education and Research (NIPER) in India as well as reputed international ones to drive this upgrade.

Our fundamentally strong analytical capability, which is anchored in cutting-edge tools, latest orthogonal approaches and world class technology, ensure the high quality and consistency of our products.

Formulation and Product Science:
During the drug development process of biologics and biosimilars, the bulk drug substance is converted into a formulation and transferred into vials and cartridges to make a drug product. This requires extensive science, complex technology, understanding of protein structures, product stability and extractable / leachable studies.

2. Analytical and Bioanalytical Sciences

Physicochemical and functional analytical technologies are the key components of the process and product. The analytical and bioanalytical laboratories in Biocon have state-of-the-art equipment and deep technical expertise. These analytical tools are applied for in-process as well as finished drug substance and drug product analyses. Sensitive and specific methods need to be devised in order to detect and measure the minutest variants or impurities. Many of these methods are transferred to the quality groups in manufacturing to be utilized as product release assays. The analytics group in Biocon has nearly 20 years of experience in analytical sciences.

3. Preclinical & Clinical Sciences

At Biocon R&D, we understand that selecting the right molecule for clinical development is key to drug development and successful regulatory approval. Our scientifically rigorous, ethically compliant and stage gate-based structured preclinical and clinical development strategy is instrumental in achieving the relevant pharmacokinetic (PK) and pharmacodynamic (PD) endpoints and establishing the safety and efficacy of our products. New approaches of predictive toxicology and adaptive clinical trial designs are being applied to significantly reduce costs and increase the quality of our trials in the future.

4. Intellectual Property

Biocon R&D has consistently created intellectual wealth through an incisive intellectual property strategy that recognises the innovative potential of our products and processes. We have filed over 1,200 patent applications and hold around 984 patents and 448 trademark registrations globally. This number is only expected to increase as our exciting novel molecules pipeline advances from the bench to the bedside in the coming years. This team has won the 'Best In-house IP Team of the Year' Award at the Global IP conclave held in 2015 and the Pharmexcil Gold Patent Award 2014-15 in the Biotech category for filing the highest number of patents.

5. Regulatory Sciences

Our regulatory sciences capabilities have enabled compliance with the highest global quality and cGMP standards. The team is gearing up for multiple global regulatory filings in insulins, biosimilar antibodies and complex generic formulations. The Regulatory Sciences team has recruited and trained a number of talented individuals who are the interface between the company and regulators. Understanding the guidelines, rules and processes of each country is a formidable task. Drug regulators from the US (FDA), European Union (EMA), Australia (TGA), Canada (Health Canada), Brazil (ANVISA), Japan (PMDA), etc. have unique country specific processes which need to be followed mandatorily.

Biocon's R&D regulatory team is playing a key role in this knowledge exchange and the evolution of the regulatory pathway for establishing comparability, interchangeability and extrapolation of indications among biosimilars.