Enabling success of small and large companies
Across their product life cycle
Exceeding your expectations from strain development through to large scale manufacturing
We strive to match your requirements with a complete line of service offerings from strain development through to large scale manufacturing. We apply 30 years of experience in microbial fermentation for biopharmaceuticals, including a proven track record of BLA design and execution and bringing products to the market to your project. Access our experience with microbial processes, where we have advanced development, engineering and manufacturing capabilities. We have an unparalleled track record in establishing scalable, commercially viable processes, from pre-clinical development through to commercial-scale manufacturing. We are agile and adjust our project plans to work with you as your needs change. Our approach is based on teamwork and knowledge sharing while working with you to define a tailored solution for each project.
Access our microbial technologies
The area of microbial biomanufacturer, to produce recombinant proteins, microbial vaccines, novel scaffolds, new molecular formats, plasmid DNA, and other biopharmaceuticals, requires customized processes tailored to the characteristics of the molecule. We have extensive experience with processes developed internally, as well as those transferred into our facilities for scale up. Our expertise includes secreted, soluble and insoluble (inclusion bodies) processes, with re-fold capabilities from small to very large scale. Using advanced engineering and process development capabilities we ensure processes are robust, scalable and reproducible. We can increase your chance of fast and successful CMC regulatory filing by aligning with your submission strategy and by supporting an on time launch at a scale that optimizes entry to market with the ability to adapt the scale to meet future market demand.
Our locations
Location where this service is provided
Visp, Switzerland
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.
Regulatory expertise
Pathway to success in Regulatory filings
Extensive Regulatory Expertise
We offer our in-depth expertise in the interpretation of legal requirements and guidance in innovative and emerging markets. Our regulatory affairs CMC experts are co-located alongside subject matter experts at our manufacturing sites around the globe. Our team has extensive experience in CMC dossier writing as well as preparing responses to questions from health authorities across the world.
Dedicated Regulatory Affairs Contact
We ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. The strategy will ensure you have the required data to support global applications.
Keep Pace with Regulatory Thinking
Our Regulatory Affairs Services prioritize transparent communication. We ensure that you are continuously informed from kick-off and during subsequent interactions, facilitating any CMC development strategy or detailed discussions.
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