Biologics Contract Research, Development & Manufacturing Organization (CRDMO) Services

Biologics CDMO Services

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At Syngene we are dedicated to propelling biopharmaceutical companies into the future with our state-of-the-art biologics contract development and manufacturing services. With a legacy spanning over 30 years, we stand at the forefront of the industry, delivering expert, efficient solutions that transform visions into market-ready realities.

Expertise Across the Spectrum

Our comprehensive suite of services encompasses every stage of the biopharmaceutical development and manufacturing process. From cell line development, upstream and downstream process development, formulation development to analytical method development and validation, we ensure a seamless, integrated approach to bringing your biologic products to life.

Regulatory Track Record

Approval from FDA, MHRA, and PMDA for manufacturing sites.

Successful Partnerships

Over 25 INDs enabled, showcasing our capability to accelerate your path to clinical trials.

Diverse Experience

Expertise in various modalities with more than 140 projects delivered.

Efficiency and Quality

Industry-leading titres and shorter timelines with a commitment to quality.

End-to-End Biologics Manufacturing

Our cutting-edge biologics manufacturing capacities guarantee efficient and scalable production processes designed to match our clients’ unique requirements. From selecting expression systems to purification and formulation, each stage is fine-tuned to uphold the highest standards of quality and productivity.

Our Services

Cell Line Development

Utilizing innovative transposon-based cell line development technologies, we accelerate the timelines for creation of high-producing, stable cell lines. Our robust platform supports a wide range of biopharmaceutical applications, ensuring the rapid progression of your product from concept to clinic.

Process Development

From upstream process development to downstream, our team excels in optimizing processes that are scalable and cost-effective. Our DoE based process development platform delivers not only high titre but optimizes for quality parameters such as like size, charge, glycan, mass and functional activity ensuring processes are ready for validation and tech transfer, setting the stage for a seamless scale-up.

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Viral Clearance

Understanding the critical importance of safety in biopharmaceutical products, our viral clearance services are designed to ensure the efficacy and purity of your products. Our comprehensive viral validation studies provide the data you need for regulatory approval, giving you peace of mind in your product’s safety profile.

Analytical Services

Our analytical services provide comprehensive support for all stages of development and manufacturing. From method development and validation to stability studies and material testing, our expert team ensures the integrity, quality, and compliance of your biopharmaceutical products.

cGMP manufacturing

Our state-of-the-art cGMP facilities are equipped to handle all phases of biologics manufacturing. From clinical to commercial scale, our capabilities ensure high-quality biologic production under the strictest cGMP standards, providing a reliable foundation for your product’s success. Read more about our expansion in biologics manufacturing capacity.

Sterile Fill Finish

Syngene Biologics offers comprehensive sterile fill and finish solutions, ensuring the integrity and sterility of your biologic products. Our facilities are equipped to handle a variety of container formats, under stringent quality control measures.

Our Manufacturing Capacity

To support our growing client demand, we have expanded our manufacturing capacity. Our latest manufacturing facility, Syngene Manufacturing Unit-3, is set to commence operations for both clinical and commercial supply by the latter half of 2024. The production capability comprises two production suites, with multiple 2KL single-use bioreactors. Furthermore, the facility has two high-speed vial filling lines capable of manufacturing up to 1 million vials per day, catering to fill volumes ranging from 1 to 100mL. Alongside its production capabilities, the site features a development suite dedicated to clinical supply of drug substance, with multiple bioreactors of 50L to 500L single-use bioreactors.