Recent developments in the fields of antibody fragments, scaffolds, and bioconjugates have spurred a renewed interest in microbial production. However some of the emerging microbial processes require specialized manufacturing capability and a highly skilled workforce to achieve cost-efficient and reliable production. In this environment, outsourcing becomes an attractive option that can release pressure on your organization and allows you to delay or even avoid high-risk investments in specific manufacturing capacity. The right partner can help you navigate the microbial field by balancing investment and timeline risks with market opportunities.
Our portfolio enables you to define your own, tailored solution from a complete set of services. We have extensive experience with microbial processes and our toolbox contains well-established technologies for efficient, scalable, and regulatory compliant processes. You can get technology access via our services offering or explore our XS Technologies™ in your own labs under license. We can help mitigate investment risks and we have the capabilities to construct customized facilities for your specific manufacturing needs.
We can help you optimize existing fermentation and purification processes to improve manufacturability, no matter the development stage or expression platform. Our scientists and engineers have the deep technological skills required to help you solve challenges, specifically in areas of solubility, productivity, product quality, and stability.
The services and equipment that we offer are fully flexible and always phase appropriate. We keep your ultimate goal in mind but focus on the next milestone so that we are always in sync with your needs. You can mitigate investment risk by partnering with us in flexible business models that provide supply solutions for different market demands.
Our service packages and licensing agreements give you access to an extensive technology toolbox with a collection of proprietary, highly productive and scalable microbial platforms that enable high-yield processes for a wide variety of molecules. This toolbox is developed with manufacturability in mind. The necessary documentation is already in place to facilitate regulatory approval.
In our microbial Center of Excellence in Visp, Switzerland, development and manufacturing teams work in close collaboration to ensure seamless transition between project phases. Each project is assigned a dedicated Project Manager, which means a single point of contact for you.
When you work with us, you have access to more than 30 years' experience in the microbial biopharmaceutical field. Our approach is based on teamwork and knowledge sharing. You benefit from our insights into best practices for commercializing microbial processes. You can merge these insights with your own knowledge and derive long-term benefits.
Technology is at the core of our microbial offering. Our XS Technologies™ platform includes Escherichia coli, Pichia pastoris and Bacillus subtilis expression systems. In our labs we routinely see productivities of up to 20 g/L for less complex therapeutic proteins, above 5 g/L for novel scaffolds and up to 600 mg/L for pDNA. Our XS Technologies™ are available for third-party use under a research license or commercial license.
Specific services that enhance our microbial offering include Light Path™ protein production services that can help reduce the time to IND filings, development of cGMP-compliant master and working cell banks, analytical development with a wide range of testing expertise in microbial products, and drug product development services for oral and parenteral formulations. We offer extensive validation support to streamline your regulatory approval process. You can also contract us for regulatory consulting with our in-house network of experts.
Our microbial drug substance manufacturing solutions are based around our microbial Center of Excellence in Visp, Switzerland, in combination with a global supply network. Visp has a manufacturing capacity up to 2 x 15,000 L and BSL-2 capabilities at all scales. If you are looking to expand your own capacity, we have the engineering expertise and financial strength to help you with new builds. One example of our innovative approaches is Ibex™ solutions modular facilities for responsive capacity saving both time and investment for your company.
We have experience within our network to develop, optimize and manufacture cross-technology medicines. Examples of our capabilities include conjugation technology and expertise within small molecules. The result is an integrated solution for complex medicines, so you can simplify your sourcing process and get to market faster.