Monoclonal antibodies (mAbs) have revolutionized modern medicine, offering precision therapies for cancer, autoimmune disorders, infectious diseases, and numerous other advantages. The global mAb therapeutics market is on a notable surge, projected to reach over $600 billion by 2031; hence, the demand for reliable, scalable, and cost-effective manufacturing partners is also rising Syngene, a leading global contract development and manufacturing organization (CDMO), is at the forefront of this transformation, enabling biotech innovators to accelerate their mAb programs from laboratory to commercial scale.
The Promise and Challenge of mAbs
mAbs are engineered proteins designed to bind with high specificity to molecules that cause diseases, enabling targeted modulation of biological pathways. They are being successfully used in several fields such as oncology, chronic inflammatory diseases, transplants, and infectious diseases. With hundreds of mAbs approved globally, they have become central to treatment guidelines and personalized medicine strategies.
Yet, the journey from discovery to market encounters several manufacturing challenges. High production costs, scale-up inefficiencies, regulatory complexity, supply chain vulnerabilities, facility limitations, sustainability pressures, and talent gaps all threaten the timely and cost-effective delivery of these life-changing therapies.
Syngene’s Customer-Centric Solutions: Raising the Bar in mAb Manufacturing
Syngene has invested in advanced technologies and process innovations to address these industry-wide hurdles. At the core of its offering lies an intensified fed-batch process, which delivers a 3-4 fold increase in production titers—enabling clients to achieve higher yields without expanding their manufacturing footprint. This hybrid strategy combines perfusion and high-seeding density methods, optimizing upstream processes and enhancing efficiency. By leveraging a unique media blending approach and scalable bioreactor conditions, Syngene ensures longer culture viability, reduced waste accumulation, and consistent product quality.
For clients, this means not only higher protein yields (up to 712 g/L) but also reduced cost of goods (COGs) and fewer batches required to meet demand. Syngene’s intensified N-1 and high-seeding density production models are transforming the economics of mAb manufacturing, making advanced therapies more accessible.
Proven Track Record: Case Studies in mAb Innovation
Syngene’s expertise is reflected in its successful partnerships with leading biotech and pharmaceutical companies:
- Boosting mAb Yield for Oncology Therapies: A prominent biotech company focused on cancer partnered with Syngene to overcome low yields and lengthy processes. By implementing Syngene’s proprietary protein platform, the client achieved a four-fold increase in titer in under a year, substantially improving efficiency and reducing costs.
- Hybridoma Platform for Cell and Gene Therapy: Syngene developed a unique hybridoma platform for a global biotech firm, enabling the integration of multiple ancillary raw materials into cocktail reagent kits for stem cell identification and analysis. This innovation is accelerating research in regenerative medicine and cellular therapy worldwide.
- Optimizing Nanofiltration for Viral Clearance: For a major pharmaceutical company, Syngene’s in-house viral testing team resolved nanofiltration challenges, reducing flux decay to under 40% and enabling higher flow rates with consistent virus clearance. This optimized process ensures regulatory compliance and cost-effective manufacturing.
- Scaling Up for Zoetis’ First-in-Class mAb: Syngene supported Zoetis in scaling up the drug substance for Librela®, the first mAb approved for canine osteoarthritis. The right-first-time scale-up from 10 to 500 L met stringent quality parameters, enabling Zoetis to secure EMA and FDA approvals and launch in the EU and US markets.
State-of-the-Art Facilities and Global Reach
Syngene’s biologics manufacturing facilities offer a total installed, single-use bioreactor capacity of 50,000 liters across the US and India, complemented by a sterile fill-finish facility capable of handling 1 million vials per day. This infrastructure provides clients with both flexibility and scale, supporting projects from early development to commercial launch.
Cutting-edge automation and digitization tools are integrated at every stage, enabling rapid turnaround, robust process control, and opportunities to improve costs and reduce environmental impact, a growing concern in biologics production.
Regulatory Excellence and Industry Leadership
With over 150 biologics projects delivered and a strong regulatory track record (FDA, PMDA, MHRA), Syngene is the partner of choice for biotechs seeking to accelerate their mAb programs. The company’s expertise in process optimization, compliance, and quality assurance ensures that clients can navigate the complex regulatory landscape with confidence.
Looking Ahead: The Future of mAb Manufacturing
As the mAb pipeline expands—with around 30 new therapies approved or under review in the EU and US between 2024 and 2025—the need for innovative manufacturing solutions is more urgent than ever. Syngene is leading the way with modular and flexible biomanufacturing setups, single-use technologies, automation, AI-driven optimization, and advanced purification systems.
By investing in talent development, sustainability initiatives, and strategic partnerships, Syngene is helping shape the future of biologics—making advanced therapies more accessible to patients worldwide.
Conclusion
Syngene’s customer-centric approach, technological innovation, and proven expertise make it a preferred partner for biotech companies in navigating the complexities of mAb manufacturing. As the industry rapidly evolves, Syngene remains committed to delivering scalable, cost-effective, and high-quality solutions that empower the next generation of biologics. To know more about Syngene’s manufacturing capabilities, click here.