The R&D team of Henlix Biotech Ltd includes experienced industry experts in monoclonal antibody drug discovery, preclinical & clinical development and commercial manufacturing of antibody therapeutics. Henlix has assembled a world class R & D team and established the state-of the-art technologies and platforms. The core capabilities of Henlix Biotech Ltd. includes integrated antibody discovery and development engine, cell line engineering to construct high productivity cell lines to yield high quality antibodies, antibody humanization and affinity maturation, bispecific antibodies, antibody-drug conjugation, and in vivo and in vitro pharmacodynamics analysis of the antibody drugs. In addition, Henlix Biotech has engaged regulatory experts for US, Taiwan and China FDA as well as clinical key opinion leaders to advance our products to clinical trials.
Maximize lead discovery efficiency using multiple approaches such as proprietary naïve human phage display library with a diversity of 1.5E+10, and conventional hybridoma technology. Developed robust screening criteria utilizing multiple in vitro assays established for each project to evaluate selectivity, affinity and potency of multiple leads. Leverage state of the art antibody technologies and established the following platforms and key competencies:
- • Bispecific antibody platform
- • Antibody-Drug Conjugate(ADC) platform
- • Enhanced Fc functions through glycan engineering
Deploy multiple strategies to improve binding affinity and efficacy of lead antibodies. Utilize biochemical and biophysical characterization to profile the lead antibodies. Conduct exploratory in vivo experiments to rank order potential leads for optimization. Utilize multiple in vivo PK/PD models and a broad range of tumor models to benchmark our lead antibodies with current standard of care and/or lead competitor.
- • Humanization
- • Affinity maturation
- • Fc engineering
Establish target product profile (TPP) to establish go/no go criteria for IND enabling studies. We adopt a reiterative evaluation process using multiple in vitro and in vivo SC xenograft models, transgenic and humanized mouse models and/or syngeneic models to conduct PK/PD and toxicology studies to identify the best preclinical candidates.
- • In vitro pharmacodynamics analysis
- • In vivo pharmacodynamics analysis
Chemistry Manufacturing and Controls (CMC)
- • Cell line development
- • Process development
- • Analytical method development
- • Quality control and quality assurance system development
- • Production technology, purification techniques, quality analysis and stability studies
Clinical & Regulatory Expertise
The Henlix team has extensive multiregional regulatory experience and expertise in regulatory submissions including IND filing preparation for FDA, TFDA and CFDA and conducting Phase I and Phase II clinical trials in Taiwan, China and US.
- • IND filing
- • Clinical trial design and execution