From the Leader's Desk

Lenmeldy (atidarsagene autotemcel) is now the first FDA-approved gene therapy to treat children with metachromatic leukodystrophy (MLD). Syngene is delighted with this approval which represents an important breakthrough in the availability of effective treatment options for rare and orphan diseases, a space that we also serve as a CRDMO.

In other news, our newly upgraded biologics facility (Unit 3) will be operational for clinical and commercial supply in the second half of 2024. With a total capacity of 20KL, the facility will be available to U.S. and European clients seeking drug substance and drug product contract manufacturing.

We are also delighted to share that Syngene was declared one of India's Best Managed Companies 2023 by Deloitte (India). The award was for overall business performance and for demonstrating leadership in strategy, innovation, culture, and sustainability, resulting in sustainable growth. We also won the CDMO Leadership Award 2024 under the Reliability and Compatibility categories for exceeding customer expectations. The award was issued by Outsourced Pharma in partnership with Life Science Leader with research by ISR Reports.

Happy reading.

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Kenneth J. Barr, Ph.D.

Senior Vice President, Discovery Services
Syngene International Ltd.

In The Spotlight

SynSight: A voluntary participation initiative to enable improved predictive insights and better, faster outcomes in drug discovery

Introducing SynSight, an "opt-in" data consortium for our clients, enabling better predictive models for more informed decisions in their projects. SynSight allows its members to benefit from anonymized data, protecting proprietary information while leveraging metadata to train algorithms, enhancing the speed and quality of decision-making, thereby shortening the design-make-test-analyze (DMTA) cycle.

Case Study

How Syngene supported a large pharma company in generating gene knockouts in iPSCs with >95% efficiency

We generated requisite iPSC knockouts in five weeks using Cas12a-mediated CRISPR gene knockout technology. We also achieved a high transfection efficiency of >95% without the need for FACS sorting. This was accomplished with high transfection efficiency and stability of clones at optimum costs.

White Paper

ADCs: Re-emergence of an old modality for targeted therapies

ADC discovery involves a multidisciplinary approach that combines knowledge from antibody engineering, linker chemistry, and payload selection. Further, the discovery, development, and manufacturing of ADCs present numerous challenges due to the complexity of these molecules and the need to balance efficacy, safety, and manufacturability. In this viewpoint article, our V.P. and Head, Discovery Biology, Jayashree Aiyar, Ph.D., discusses the top challenges in ADC discovery and how leading CRO/CDMO Syngene is supporting clients in developing innovative ADC molecules.

Scientific Poster

Predicting genotoxicity and carcinogenicity of drugs and chemicals using OECD QSAR toolbox, Derek® Nexus and TEST

Assessing the genotoxicity and carcinogenicity of chemical substances is essential for ensuring drug safety and for gaining regulatory approval. A battery of experimental tests required for these assessments comes with time demands, ethical concerns, and costs. In this poster, we have compared results from in silico prediction of genotoxicity and carcinogenicity of various drugs with the results from curated data in published literature.