Doer Biologics is focused on the development of multi-domain-based, multi-specific innovative protein drugs in the fields of cancer, endocrinology, metabolic diseases, and ophthalmology.
The terms of agreement allows Doer Biologics access to Lonza’s XS Technologies microbial expression system for research purposes.
“As part of this agreement, Doer Biologics received multiple host strains of Escherichia coli and Pichia pastoris, a range of promoters, helper factors and signal sequences. Doer Biologics also received access to specially designed feed regimes and Lonza’s expert know-how, to help them advance molecules to market faster,” Peter Droc, head of licensing and drug product services, Lonza, told BioPharma-Reporter.
Lonza says its XS Technologies will enable Doer Biologics to develop scalable, robust, time- and cost-efficient expression processes. How so?
“The success of any production process depends on numerous factors. In addition to the platform used, manufacturing must harness and optimize complex interactions. For example, balanced growth and production phases can maximize yield. However, that yield may exact a tradeoff with the accumulation of toxic metabolites, which, together with host protein, can impact downstream applications. Hence, alignment is required to ensure performance and prevent unwanted post-translational modifications.
“The XS Technologies platform offers a toolbox to explore different options for system components and design, for optimum expression of a given product. This will enable Doer Biologics to establish productive, robust, scalable and efficient cGMP processes more quickly and easily,” said Droc.
Microbial expression systems
For more than 20 years, Lonza has pioneered enhanced microbial expression systems, he remarked.
These have been implemented in over 130 projects for a wide range of proteins, some of which have advanced to clinical development, added Droc.
“These include strains developed expressing recombinant proteins such as enzymes, cytokines, fusion proteins and growth factors; also next generation biologics such as scFv and antibody mimetics.”
With such a rich history of delivering projects, Lonza, he said, is well place to support Doer Biologics in advancing molecules to market.
Easy downstream processes
Dr Yanshan Huang, founder and CEO, Doer Biologics, said: “A growing number of biotech and biopharma companies are developing multi-specific antibodies, and Lonza's XS Pichia enables Doer Biologics to translate lead molecules into the clinic in a fast and low-cost way and potentially [enabling us to] stand out from the competition.”
Going into specifics, he said Lonza's XS Pichia offers the company several competitive advantages: (1) producing high titer and high-quality proteins as a result of excellent strain engineering; (2) rapid turnaround time as Pichia grows faster than CHO cells, and (3) lower cost and easy downstream processes as a result of methanol-free induction.
Dr Huang told us his company is advancing multiple programs, which include bi-specific and multi-specific biotherapeutics.
“DR30206 is a preclinical tri-specific antibody targeting PD-L1, VEGF, and TGF-beta and can potentially be used to treat various solid tumors that may be low or non-response to conventional PD-1/L1 mAb.
“DR303018 is a preclinical tri-specific antibody targeting CLDN18.2, CD3, and HSA and can possibly combat gastric or pancreatic cancers in the clinic.
“Doer Biologics is also developing innovative T cell engagers targeting multiple tumor-associated antigens (TAA), which can increase selectivity and lower down toxicity.”