Development

▸ Development

Syngene is a full-scale Contract Development and Manufacturing Organization (CDMO) with extensive experience in serving the needs of both Small Molecules and Biologics industry. Our clients range from small and medium BioPharma to large BioPharma companies from around the globe.

Syngene offers preclinical development, API and drug product development for both small molecules and Biologics. We offer drug development services from lead generation to clinical supplies of drug substance and drug product. Our Clinical development services are across Phase I, II & III trials. We also support our clients in drug filing with FDA and other global regulatory authorities.

What sets our Development services apart, is our full-service capability and well-rounded expertise to enable seamless integration of R&D programs, resulting in faster go-to-market opportunity for our clients.

Small Molecules

We offer end-to-end services for small molecule development from pre-clinical to commercial supply. Whether it is a drug substance or drug product, manufacturing a few grams or several kilos, non-GMP or GMP manufacturing, we have the expertise to take your programs forward efficiently and quickly. Our product range includes APIs/intermediates, RSM/KSM, high potency API, new chemical entities, novel advanced intermediates, oligonucleotides, ADCs, and Performance and Specialty chemicals.

Our Chemical Development (drug substance) services include route scouting, chemical process design development and optimization, technology transfer, and clinical and commercial manufacturing. Our Formulation services include pre-formulation, toxicology formulation, pharmaceutical formulation, bioavailability and solubility enhancement, process development and scale-up, and clinical supplies. We also offer Analytical development, including nitrosamine impurity testing and stability services. Our Clinical Development services include human pharmacology studies – BA/BE studies, bioanalytical laboratory services, clinical trials, medical writing and medical, regulatory services, biometrics, and clinical data management.

Chemical Development

Formulation Development

Analytical Development

Clinical Development

Biologics

We work with diverse Biological entities like Monoclonal Antibodies, Antibody Fragments, Recombinant Proteins, Glycoproteins, Pegylated Proteins, Subunit Protein Vaccines, mRNA, microbial (E. coli and Pichia), microbiome Live Biotherapeutic Product and Multimeric Protein Complexes. Our services include Cell line Development, Developability Assessment, Process Development, Viral reduction steps and clearance studies, Product Characterization, Bioassays, Stability Studies, Formulation Screening, Drug Substance- Upstream and Downstream Processing (Mammalian, Microbial), Drug Product- Clinical Supplies, ready to use vials/PFS, Analytical method transfer, Analytical method validation, Viral Testing and Clearance services, and Bioanalytical Laboratory services

Our Development Services are available as both stand-alone services, and as defined integrated activity bundles. We also offer customized solutions appropriate to client R& D programs. Our scientists have cross-functional, multi-disciplinary expertise in implementing integrated programs as well. We have a consistent track record of managing and executing projects of diverse complexities for a global clientele with 400+ patents held with clients so far.