Development Services

Advancing innovation from laboratory to launch

We focus on advancing small molecules and next-gen modalities like ADCs, oligonucleotides, and peptides, ensuring efficient, sustainable, and scientifically rigorous transitions from development to GMP-compliant manufacturing.

Chemical Development Overview

The Chemical Development department provides end-to-end process development and bulk manufacturing in both cGMP and nGMP modes. Our advanced PRD lab, with integrated safety and engineering capabilities, ensures smooth scale-up and production.

Operations across our sites in Bengaluru and Mangaluru support business continuity, addressing supply chain, compliance, documentation, and workforce resilience.

We are advancing next-gen modalities like ADCs, oligonucleotides, and peptides, working closely with customers to develop payloads, linkers, and conjugation strategies for mAbs.

To drive sustainable innovation, we’re investing in biocatalysis for cleaner, more efficient synthesis and expanding expertise in Photoredox and flow chemistry.

Performance Overview

Development services performed steadily in FY25, fueled by repeat orders and new integrated collaborations from drug development to clinical-stage manufacturing. Early-stage small molecule process development saw strong growth, with successful project deliveries paving the way for future expansion.

We focused on enhancing capabilities, upgrading facilities, and onboarding experts for emerging pharmaceutical modalities. Streamlined documentation processes ensured timely deliveries while maintaining regulatory compliance.

Capability Expansion

• We established a dedicated laboratory for potent molecule synthesis, boosting our ability to manage complex projects. Our upgraded Chemical Development Laboratory is now operational, increasing project throughput, with a specialized hazardous lab for safe handling of cyanide and toxic reactions.
• A bench-top biocatalysis capability for new modalities was developed, with enzymatic screening underway. Additionally, a state-of-the-art facility at our Mangaluru site was commissioned to handle OEB-4 (Occupational Exposure Banding) molecules, enhancing our capacity for high-potency compounds.

Pioneering Breakthroughs in Process Innovation

Our team collaborated with global customers, adopting advanced methodologies to improve yield, purity, and cost efficiency without compromising safety or quality. Achievements included reduced manufacturing costs, minimized waste, and optimized results beyond initial expectations.

The peptide and oligonucleotides teams drove significant process improvements, ensuring timely, high-quality solutions. Additionally, the CD-PRD team published a paper in Organic and Process Research & Development (2024) on successfully scaling a stereoselective cyclopropanation for Factor-D inhibitors, overcoming challenges with pyrophoric reagents under cryogenic conditions. The publication recognized 12 Syngene co-authors.

Advancing Sustainable Practices

• We optimized the process for a rare disease molecule, reducing PMI from over 40 to below 15, increasing yield to 60%, and halving cycle time. This improved process delivered 26% more product with the same raw materials, reducing waste and improving resource efficiency.
• A scalable process for an alcohol-based intermediate enhanced reaction efficiency and reliability, increasing yield by 10% and reducing Cost of Goods Sold (COGS) by 5%. We also optimized an ADC molecule process, addressing crystallization and purification challenges, resulting in a 10% reduction in E-factor and minimizing waste.
• To drive sustainable innovation, we are investing in biocatalysis for cleaner, more efficient synthesis and expanding expertise in Photo redox, electrochemistry, and flow chemistry.

Innovative Synthetic Approaches

Integrated Drug Development (IDD) Program

• In collaboration with a U.S. based biotech firm, we developed a polymer-based drug for a rare inherited metabolic disorder. The process was successfully scaled up for bulk batches, optimizing raw material use and cycle times, and is now ready for cGMP manufacturing.
• The team also developed a novel activated polymer for enzyme conjugation, with plans for cGMP scale-up. The process aligns with sustainable practices, reflecting our commitment to green chemistry. Additionally, we developed a polymer library for RNA encapsulation in genetic disorder treatments, completing the project on time and maintaining high material quality.

Enhancing Quality Excellence and Productivity

The PRD team identified documentation and plant support as productivity barriers. To address this, a dedicated team was formed to simplify SOPs, reducing turnaround time and eliminating non-value-added tasks. This streamlined approach improved focus on core activities, ensured seamless customer communication, and led to smoother operations and successful project outcomes.

Innovations in Material Science

We partnered with a customer to develop ionic materials for clean energy, achieving four times the stability and performance of market benchmarks. Large-scale production of 300-meter membrane rolls was successfully executed, advancing decarbonization efforts.

The team also developed a novel library of cross-linkable polymers for Printed Circuit Board (PCB) applications, with ongoing investigations into crosslinking reactions. Additionally, a polymer was successfully conjugated with a therapeutic protein, advancing its potential for rare disease treatment.

Risk Management

We successfully managed the handling of TMSCN (cyanide) in an acidic medium, effectively controlling the release of hazardous HCN (hydrogen cyanide) gas. A thorough risk assessment was conducted from raw material procurement to manufacturing, with all safety recommendations implemented. The safe execution of three batches was shared with the customer, who praised Syngene’s risk management protocols.

Analytical Development

The team completed its first chiral purification by Supercritical fluid chromatography (SFC) for linker moiety at the manufacturing facility, boosting QC confidence for future projects. New customers were onboarded, and high-value analytical method development proposals were received, showcasing our technical expertise.

A new model introduced staged training for process chemists on UPLC/HPLC for IPC analysis. Capabilities were enhanced with Prep HPLC, Arc HPLC with SEC-MALS (Size Exclusion Chromatography with Multi-Angle Light Scattering), and potent molecule prep isolation. Over 90% of projects are now recorded in electronic lab notebooks, improving efficiency and data security. A phase gate quality system was also implemented to ensure Right First Time accuracy during method transfers.