Biotechnology Development

MEDICAL BIOTECHNOLOGY / Biotherapeutic Products

Research Interests

Biologics, biosimilars, bioprocessing, technology transfer, trainings

Description of Research

Globally, biosimilars have substantially lowered the cost of biologic medicines, making them essential in improving access to treatment. However, in many LMICs, access remains limited because countries depend heavily on imports of these medicines, and local manufacturing capacity remains low. The Biotechnology Development Unit (BDU) directly addresses this gap by helping partners build the skills, technology, and infrastructure needed to produce safe, effective, and affordable biologics domestically. The BDU plays a central role in this work by developing simple, reliable, and cost-effective methods for making biosimilars and then transferring these methods to Member countries. A crucial part of our technology transfer programme is hands-on training, which takes place in specialised facilities that operate similarly to pharmaceutical manufacturing environments. Expert scientists train visiting personnel in production, purification, and quality testing in accordance with international standards. Another key area of our activities aims to promote and apply best practices and standards, Good Manufacturing Practice (GMP), for the production of biologics across LMICs, through biomanufacturing training and TT workshops.

Our research group is currently focused on developing biosimilar versions of two important therapeutic monoclonal antibodies: Trastuzumab and Pembrolizumab. Since one of the major limitations in producing these antibodies efficiently is the bottleneck in the cell’s secretory pathway, part of our work aims to overcome this challenge. We are applying machine-learning-based optimisation of signal peptide sequences to enhance cells’ ability to secrete antibodies. By improving this critical control point, we aim to increase overall production yields and make biosimilar manufacturing more efficient and cost-effective.

In addition to our antibody-related research, we are developing and producing peptide-based medicines. A key focus is the GLP-1 receptor agonists Liraglutide and Semaglutide, which are widely used treatments for diabetes and weight management. Our efforts involve optimising production strategies to ensure high-quality, affordable versions of this increasingly important therapeutic peptide.

Trastuzumab antibody is a key therapy for HER2-positive breast cancer. Still, its large molecular size limits tumor penetration and results in poor pharmacokinetics, requiring high, frequent doses and increasing the risk of systemic side-effects. Sustained, localised delivery systems may improve therapeutic exposure while reducing dosing burden. Peptide hydrogels are particularly promising due to their biocompatibility, biodegradability, and ability to encapsulate and release large biologics. We aim to develop a peptide-based hydrogel platform for extended-release Trastuzumab delivery to HER2+ solid tumors. We have tested different low-molecular-weight peptide hydrogelators, enabling high antibody loading and sustained release for up to one week in vitro. Upcoming in vivo studies will assess antibody distribution and antitumor activity. To further prolong release, we introduced an affinity-based approach using the HER2 epitope–mimicking peptide. We are currently working on the co-formulation of HER-2 mimotope with a peptide hydrogelator to enable higher Trastuzumab loading and extended release over time. This localised delivery strategy may enhance tumor exposure, delay resistance onset, and improve therapeutic outcomes for HER2+ breast cancer.

Recent Publications