Pharmaceutical Development of a Broad-Spectrum Antibacterial Candidate for Multidrug-Resistant Infections
Introduction The World Health Organization (WHO) has identified antimicrobial resistance (AMR) as one of the top ten global public health threats. Despite concerted global efforts, AMR infections caused 4.95 Mn deaths in 2019. A clinical-stage biopharmaceutical company has been working on AMR since 2016 in collaboration with Syngene. They have developed a small molecule, a […]
Syngene Enhances Bispecific Antibody Production
Introduction The GEM-DIMERâ„¢ platform is a proprietary technology developed by Hinge Bio. This technology allows the production of antibodies with enhanced multivalency and multispecificity, enabling the simultaneous targeting of multiple diseaseassociated antigens. As a result, it has the potential to deliver significantly better therapeutic outcomes. The platform also supports cooperative binding to disease targets, leading […]
Enhancing Patient Compliance: Developing an ExtendedRelease Anti-Epileptic Drug
Introduction The current immediate-release (IR) tablet formulation for epilepsy1 , available in Europe, requires multiple doses due to the drug’s short half-life, making it inconvenient for patients. This case study explores the development of an extended-release (ER) formulation by Syngene’s Formulation Development team for an anti-epileptic drug, aimed at reducing the need for frequent dosing […]
Syngene partners with a client for Global Economy Decarbonization
Introduction Renewable energy sources are powerful energy alternatives that can tackle climate change challenges and fossil fuel depletion. The Performance & Specialty Materials (PSM) team at Syngene aimed to develop innovative materials for a customer advancing in clean energy solutions such as green hydrogen. This project contributes to global decarbonization efforts by addressing the challenges […]
Chiral Inversion Analysis for a Clinical-Stage Biopharmaceutical Company
Overview Syngene collaborated with a clinical-stage biopharmaceutical organization focused on advancing targeted protein degradation therapies. Their mission is to develop next-generation medicines that transform patient outcomes, particularly in oncology. By leveraging a proprietary platform, the company designs and optimizes small-molecule therapeutics aimed at challenging disease targets, including those traditionally considered undruggable. Scientific Background Chiral inversion […]
Accelerating development of a unique molecule to treat lung cancer
Overview A leading pharma company had conceived a unique molecule for targeted treatment of locally advanced lung cancer with a specific mutation. The company partnered with Syngene to provide the drug substance and drug product for tox studies. Our team worked collaboratively with the company to develop and supply the drug substance and drug product […]
Selecting the right preclinical species for screening oral dosage form for PK studies
About the Client The client is a mid-size European Pharmaceutical company intending to develop an extended-release (ER) tablet of the marketed drug using a 505 b(2) regulatory filing for the treatment of epilepsy in humans. The Challenge The marketed drug showed fast absorption and the current dosing regimen for adults is 50 mg as loading/initial […]
Developing a stable specialty polymer for use in energy applications: A collaboration with Notark
The Overview Notark wanted to develop a stable, specialty polymer that could cater to the highly evolving energy sector, where energy is derived from renewable sources rather than conventional fossil fuels. The company had built a breakthrough technology platform to develop the molecule, but encountered stability issues midway. Syngene supported Notark in resolving key technical […]
Enabling high product quality, and yield through process optimization for biologics
The challenge The client is a biopharma company specializing in late-stage process development, technology transfer, scale-up, and manufacturing. The client had completed clinical trials and was ready to start manufacturing the process performance qualification (PPQ) batches for their biologics when they noticed a difference in product quality as compared to the earlier batches. This was […]
Direct scale up from clone to 2K GMP batches
The challenge The client is a biopharma company that focuses on early-stage clinical trials. The client had developed a clone that had to be scaled up from lab scale to clinical scale without affecting product quality and titer. The client needed an experienced partner to manage the process complexities, including challenging feed and gassing strategies. […]