SynWeave™: Revolutionizing Biopharma Manufacturing with Enhanced Titer, Timelines, and Manufacturability

In a significant advancement for the biopharmaceutical industry, Syngene has introduced SynWeave™, a cutting-edge platform designed to address key challenges in therapeutic protein production. This innovative technology promises to deliver high-titer clones, shortened development timelines, and improved manufacturability, potentially transforming the landscape of biopharmaceutical manufacturing.

Transposon Technology Drives High-Titer Production

SynWeave™ leverages transposon-based technology to achieve remarkable improvements in protein expression. Initial results demonstrate titers of 3 to 4 grams per liter for monoclonal antibodies, with the potential for further increases through upstream process optimization. This represents a significant leap forward in production efficiency, particularly for complex therapeutic proteins such as antibodies, bispecifics, and antibody-drug conjugates (ADCs).

The platform's cell line development workflow incorporates codon-optimized genes and single-cell cloning using the Cytena system, ensuring monoclonality and high expression levels. The AMBER 250 bioreactor system, coupled with Design of Experiments (DoE) methodology, allows for rapid screening and optimization of production conditions.

Accelerated Timelines and Enhanced Manufacturability

SynWeave™'s streamlined approach significantly reduces development timelines, a critical factor in the fast-paced biopharmaceutical landscape. By minimizing experimentation and employing a "first time-right" strategy, the platform enables quicker market entry for new therapies.

The technology also addresses manufacturability concerns, producing clones with high stability and consistency. Stability assessments show minimal titer decrease across sixty generations, with highly conserved product quality. This enhanced manufacturability reduces risks associated with scaling production, facilitating smoother transitions from lab-scale to industrial-scale manufacturing.

Case Studies Demonstrate Significant Improvements

Syngene has reported impressive results from SynWeave™ implementation. In one case study, upstream process optimization led to a four-fold titer increase, reaching 7.2 grams per liter. Another project saw process time reduced from 22 to 17 days, while simultaneously boosting titer from 0.8 to 4.2 grams per liter. These improvements were successfully scaled up to 500-liter production, achieving consistent titers of 5 grams per liter.

As the biopharmaceutical industry continues to evolve, platforms like SynWeave™ are poised to play a crucial role in meeting the growing demand for efficient, high-yield production of therapeutic proteins. With its combination of advanced technology and expert process development, SynWeave™ represents a significant step forward in biopharmaceutical manufacturing capabilities.