03.13.23 -- Overcome Complex Protein Challenges With Optimized Expression Technologies

In a recent webinar, experts from Lonza convened to explore how it is able to guarantee customers five months from DNA to tox drug substance and 11 months to investigational new drug designation (IND) filling for antibodies using its Ibex®️ Design 2.0 Program.

A recent survey commissioned by Lonza polled the world’s drug manufacturers to discover the biggest challenges they were facing when developing new molecular formats, judged on both frequency and difficulty. To gain wider insights on industry-wide challenges in upstream, downstream, and analytics, read the summary article.

The global presence of next-generation therapies is expected to grow at a rate two times faster than standard antibodies, due to their ability to be more precisely targeted and more potent. Nevertheless, realizing their potential calls on appropriate expression technologies and development processes that can facilitate their path to market.

Discover the impact that poor assembly and expression can have on downstream purification and formulation and how addressing these challenges early, using specialized strategies and technologies, ensures cost-effective production of high-quality bsAb-based drug candidates to tight timelines.

Lonza’s CMC strategy for bispecifics offers customers an end-to-end comprehensive DNA-to-IND offering with reliable timelines backed by Lonza’s decades of experience in biologics and investment in cutting-edge technology, which reduces risk and increases speed to clinic.

New molecular formats and other recombinant proteins present facility- and product-specific development requirements that often render platform approaches inappropriate. Accordingly, addressing the most pressing challenges in process and analytical development associated with novel molecular biologic formats requires a keen understanding of the applicable tools and strategies.

While bi-specific antibodies (bsAbs) share structural similarities with monoclonal antibodies (mAbs), downstream purification faces challenges with bsAb-specific by-products such as mispaired chains, unwanted fragments, and higher aggregation levels. Stuart Jamieson and Alice Harrison discuss the downstream issues that development scientists encounter and the need for rapid method development.

Increasing demand for new molecular formats has created challenges in expediting the development of the analytical methods and the required production processes. Discover strategies to overcome challenges and meet the demand to accelerate the speed-to-clinic of multi-specific, multichain new molecular format therapeutics.