Managing the progress of small molecule lead candidates from the discovery phase through early development and clinical scale manufacturing, Syngene offers a wide range of services, including API and drug product development, pilot-scale manufacturing, and GMP production. Our focus on a range of modalities with state-of-the-art oligonucleotide and High Potent API GMP manufacturing facilities further sets us apart as a preferred development partner for therapeutic categories in small molecules.
Over the years, Development Services has continually enhanced its capabilities to keep pace with evolving science and technology. Today, our extensive range and expertise enable clients to access cutting-edge innovation, optimize processes, shorten clinical trial timelines, and adopt environmentally sustainable methods. Our GMP facilities are approved by regulatory agencies like the US FDA, EMA and PMDA.
Our comprehensive CMC services make us a one-stop shop, streamlining the outsourcing needs of our clients ensuring a seamless and well-documented CMC review, facilitating the transition of compounds into clinical phases, a key regulatory requirement.
We also cater to customer requirements on polymeric materials synthesizing and enhancing the properties of compounds in areas such as biopolymers, specialty polymers, highly active monomers, and performance chemicals by delivering customized solutions from just a few grams to tons.
During the year, we focused on integration of our services, strengthening our position as a CMC service provider. Development Services performance was underpinned by high operating standards which drove repeat orders. Our scientific excellence led to enhanced yields, resolution of complex issues, successful crystallization and delivery of complex dosage forms for multiple clients.
Non-GMP Facility:A new non-GMP facility for API synthesis was commissioned offering agile and cost-efficient services for early-phase development and scale-up. This allows for more competitive pricing and faster project completion, providing a quicker route to market without the extra costs associated with GMP compliance. This facility also provides us with flexibility to backward integrate APIs to starting materials building a cost competitive and resilient supply chain.
Dedicated Animal Health Facility:A dedicated cGMP (Current Good Manufacturing Practices) API manufacturing facility for animal health clients was operationalized, positioning the Company as an end-to-end supplier for animal health discovery, development and manufacturing services.
Process Research and Development Laboratory:A fully integrated facility bringing together a process safety laboratory, an analytical laboratory, and a kilo laboratory was opened. This multi-dimensional design streamlines the development process, enabling faster progression from earlystage research to viable drug candidate production.
Stabilized operations in injectable fill finish facility:The operation of the clinical scale fill finish facility, opened in FY23, were streamlined including successful delivery of clinical batches for the US market. The product is now progressing into phase II following a successful phase I and IND submission with drugs supplied from the fill finish facility.
Supercritical Fluid Chromatography (SFC):The Company operationalized an SFC capability to enable delivery of Highly Potent API end-to-end from development to manufacturing, including chiral purification and separation.
Every development project is unique, requiring knowledge and flexibility to meet the diverse needs of stakeholders. Our expertise in formulation, analytics, clinical, chemical development, and safety materials allows us to assemble multidisciplinary teams capable of addressing complex challenges. We aim to lead in quality, speed, and cost efficiency in small molecule development with modern infrastructure ensuring competitive pricing.
We prioritize environmentally-conscious solutions in our projects, exemplifying our commitment to green chemistry principles. For instance, in a recent oncology compound project, we not only achieved a 10% yield increase but also significantly reduced methanol and acetonitrile consumption, resulting in an 87% waste reduction and considerable cost savings.
In a project involving synthesis of triblock copolymers for marine coatings, RAFT (reversible addition−fragmentation chain-transfer) polymerization was used to streamline the synthetic process, ensuring precise monomer integration and addressing biofouling concerns.
We tackled the scarcity and quality issues of critical reagents like 2-Fluoroaniline in API manufacturing. Through customized distillation processes, we enhanced quality, increased recovery rates, and eliminated process-related impurities, meeting both regulatory and customer demands.
In our pursuit of excellence, we achieved exceptional purity levels in synthesizing complex compounds by adopting alternative reagents and solvent substitution strategies, alongside innovative purification methods, surpassing client expectations.
Our Performance and Safety Materials team developed functional materials for electric vehicles offering solutions to enhance battery safety and efficiency, thus contributing to the advancement of electric vehicle technology.
Successful synthesis of lipid-conjugated polyvinyl alcohol opens doors for various biomedical applications including water-soluble films and pharmaceutical formulations, facilitating the delivery of advanced RNA-based treatments that contribute to the advancement of healthcare solutions.
The Formulation team delivered a breakthrough in stable nasal formulations for mucolytic drugs by addressing solubility and pH stability challenges, advancing treatment options and patient comfort.
The Performance and Specialty Material team developed a novel biodegradable polymer and nanoparticle-based intravitreal injection which incapsulates the surface modified polymer (PLGA‑PEG).
These accomplishments underscore our relentless pursuit of excellence and innovation across diverse domains, driving positive impacts in healthcare and sustainability.
We offer a wide range of analytical development capabilities for complex generics, animal health, oligonucleotides, nitrosamine and NDSRI’s testing, and stability studies. Our one-stop solution allows us to handle analytical requirements from development to commercialization.
During the year, we commissioned a new laboratory with advanced capabilities such as particle size characterization, inductively coupled plasma mass spectrometry, and gas chromatography, which adhere to regulatory requirements. We also offer a straightforward approach to impurity isolation and purification through the prep-HPLC system. Our laboratory features high-scale capabilities in Supercritical Fluid Chromatography that offer superior speed, safety, wide applicability, and significant solvent cost savings.
