Comprehensive preclinical evaluation of bile acid modulators for paediatric liver disease
About the client The client is a biopharmaceutical company dedicated to developing novel bile acid modulators to treat orphan paediatric liver diseases and other liver and gastrointestinal disorders. They focus on discovering and optimizing compounds with potential therapeutic impact. The challenge The client had advanced two compounds for further development into the clinical stage — […]
Developing a green synthesis process for a growth promoter drug for animals
The requirement An animal health company commissioned Syngene to develop an environmentally friendly synthesis process for a growth promoter drug in phase 1 clinical trials that could drastically reduce the cumulated environmental factor (cE-factor) and process mass intensity (PMI) values compared to the traditional workflow. Scope of work The scope of work was as follows: […]
Enabling a four-fold increase in titer for mAb manufacturing using Syngene’s platform process
The requirement A prominent biopharmaceutical company focused on advancing monoclonal antibody (mAb) therapies for cancer treatment was seeking a contract development and manufacturing organization (CDMO) capable of addressing their complex manufacturing requirements. The project demanded expertise in optimizing upstream development processes to generate high-titer clones with stringent quality attributes, all within an aggressive one-year timeline. […]
IND-enabling safety tox studies for FDA submission in just 9 months
About the client The client is a clinical-stage pharmaceutical company dedicated to developing and commercializing proprietary therapeutics that modulate lipid-signalling pathways. The company is advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. The requirement The […]
Developing a unique hybridoma platform for manufacturing mAb cocktail formulations
The context Monoclonal Antibodies (mAbs) derived from hybridoma cell lines are integral to therapeutic applications and used to prepare reagent kits. Hybridoma is one of the platforms used to produce monoclonal antibodies (mAbs) against specific antigens The requirement The client is a global biotech company that develops and manufactures cell culture media and cell separation […]
How Syngene’s tech transfer approach helped a biotech company fast-track NDA approval for a novel compound to treat infections
Overview A leading biotech company was looking for a partner who could manufacture registration batches of their drug for NDA approval. The drug was a novel compound with an innovative mechanism of action for treating infections. Syngene ensured 100% first-time-right technology transfer by designing the right set of experiments and manufacturing limited number of batches […]
How Syngene’s safety tox package helped Cytopeutics to advance its cell therapy drug to the Clinic
Overview Cytopeutics was searching for a partner to prove the safety of its cell therapy products (e.g., hMSCs) prior to submission to regulatory authorities in the Asia Pacific region and National Pharmaceutical Regulatory Agency, Malaysia. The company was interested in conducting clinical trials for disease indications like autoimmune and other diseases. Cytopeutics partnerned with Syngene […]
The Many Benefits of Outsourcing Stability: A Baxter-Syngene Case Study
Benefits of outsourcing stability testing One of the key benefits of outsourcing is the access to infrastructure. Manufacturers do not have to acquire the equipment/ technology or invest in any of the assets, which might not be cost-effective in the long term. Instead, they can choose to outsource, where they also get the benefit of […]
Multidrug combo for companion animals
Business Problem One of our leading multi-national animal healthcare clients was working on a novel three-drug combination product for the treatment of seasonal ticks in companion animals. Â The client wanted to stabilise a low dose drug which is highly prone to hydrolytic degradation, and also ensure content uniformity of the active within the microgram dosage. […]
How Syngene’s ‘first-time right’ process advanced a novel vascular calcification inhibitor API from Lab-scale to Tox-batch manufacturing successfully
Overview A leading pharma company had developed a small molecule drug candidate to treat vascular calcification disorders. The molecule was developed using an 8-step synthetic process. The company decided to partner with Syngene for the chemical development of the molecule for non-GMP and GMP manufacturing. The Syngene team recommended a thorough mechanistic investigation to satisfy […]