Benefit from more than 30 years of innovation in microbial biotechnology and get access to our toolbox of strain design options which provide the greatest probability of delivering a commercially viable strain that meets product quality targets and titers suitable for future market demand.
In our 30+ years' experience in microbial biopharmaceuticals we have worked with more than 3,000 individual microbial strains.
0.1 to 30g/L
Our strains have produced titers from 0.1 to 30g/L for a variety of molecule types including new molecular formats, recombinant proteins and enzymes
2mL to 15,000L
Our strains deliver consistent productivities from 2mL microtiter plates up to 15,000 L commercial scale
Access our XS Technologies® offering
No single host type or vector is capable of being the best expression option for the diversity found in microbially derived biopharmaceuticals. To address this, our portfolio of powerful expression tools includes three E.coli and three Pichia pastoris systems. Lonza’s E.coli expression platform performs well for most molecules while our Pichia platform enables the production of more complex proteins.
We have a number of genetic elements that support generation of high product titers and product quality attributes. Some of these include helper factors that selectively increase titer, proprietary signal sequences that promote periplasmic production and secretion into culture supernatant and a variety of chromosomal integration sites for our Pichia systems. To mitigate the lack of predictability for quantity and quality of the protein of interest a combinatorial screening approach is applied to both E.coli and Pichia systems.
A choice of Feasibility Programs designed to meet your goals – Proof of Concept (PoC) and Full Scope workflows
If you are not sure which expression host or system is the best for your product, we have two XS® Feasibility programs designed to help you make an informed decision. The PoC Feasibility Program screens tens of host/vector combinations very quickly to identify the best suited expression platform for your molecule and provides proof of concept material to you when you need it.
The Full Scope Feasibility Program is based on a rational selection of hundreds of host-vector options where the best production clone is selected out of a broader screening set. The more you screen the better the performance of the selected clone will be and the greatest chance of meeting the desired outcome (ie titer/product quality). We use a selected number of analytical methods to address quantity and quality throughout this process.
Our feasibility programs are designed to accelerate your activities by providing information to allow you to make an informed decision early in your development program.
Proof of Concept Feasibility Workflow
High productivity from XS® Strains across a variety of molecule types
Lonza has extensive experience in producing a variety of microbial derived biologics including recombinant proteins, new molecular formats, novel scaffolds, conjugated vaccines etc. Our experience includes hundreds of proteins with different physico-chemical properties and molecular weights from 2 to 220 kDa. The bacterial cell has the choice of production in the cytoplasm, the periplasm, or inclusion bodies (IB's). The expression mode is the most relevant parameter defining the titer distribution. Higher productivities are possible in the cytoplasm, either soluble with a median of 11 g/l or insoluble at 8.8 g/L. Since E.coli is not a secretion host the titers in the periplasm or in the cell-free medium are considerably lower with a median of 1.5 or 2.0 g/L.
High productivity independent of the product class, molecule weight and expression mode
The safe and reliable preparation of the production strain is of great importance. It ensures the integrity of the product during its development and allows for consistency during commercial production. Establishing a cGMP master cell bank (MCB) and working cell bank (WCB) is considered the first critical step for the quality of microbial biopharmaceutical production. We offer cGMP-compliant master and working cell banking services to customers who are using Lonza’s process R&D service platforms.
Our banks include the required culture control testing of culture viability, strain identity, culture purity, genetic stability and use testing.
Whether it is strain development, individual cell bank characterization or testing and storage services, our experienced team will be ready to meet your cell banking needs.
Ensuring a well-characterized starting culture for consistent production
Founded in 1897, Lonza today is a dedicated strategic manufacturing partner to the healthcare industry, working with customers in the pharma, biotech and nutrition markets. Visp remains our largest site in a global network of more than 30 sites and one of the most significant for research and development and manufacturing.
Our Visp site is a complex of industry-leading facilities specializing in the development and manufacture of products for pharmaceutical applications including mammalian and microbial biopharmaceuticals, small molecules, highly potent APIs, peptides and bioconjugates including antibody-drug conjugates (ADCs). It is also home to our Ibex® Solutions pioneering services offering. Ibex® Solutions enables customers to accelerate their path throughout the complete biopharmaceutical lifecycle - from preclinical to commercial stages, from drug substance to drug product, all in one location.