Lonza’s versatile development and manufacturing facilities for injectible-grade biopharmaceuticals produced in microbial organisms are located in Visp, Switzerland, and Hopkinton, Mass. (USA), with additional oral-grade facilities in Kourim, Czech Republic. Lonza's microbial process development and manufacturing professionals are highly experienced in developing, optimizing and scaling up microbial fermentation and product isolation processes. Technical experts are involved right from the start of the project and remain involved during process transfer and production. This ensures a smooth transition from the project’s early phase up to commercial scale. Over the years, Lonza has become a recognized leader for outsourced microbially derived active pharmaceutical ingredients (APIs) and chemical intermediates. cGMP Production Sites: Covering North America & Europe Visp, Switzerland 20L, 1,000L, 2x15,000L (expansion planning under way for additional mid- and large-scale capacity) Hopkinton, Massachusetts, USA 40L, 150L, 800L, 2,000L, 2,800L Kouřim, Czech Republic 5x15m3, 5x50m3, 2x75m3 (oral-grade only) All our facilities conform to cGMP standards and have been successfully audited by customers and regulatory authorities. Proprietary Technology: State-of-the-Art Expression Platform Lonza established the XS Microbial Expression Technologies™ as an advanced and versatile biopharmaceutical production platform. This portfolio of expression systems encompasses E.coli, P. pastoris and numerous other microbial expression hosts. It enables the delivery of high expression levels for various product types from gene to cGMP production in as little as 9 months. Quality Product Management: Our Commitment for Time & Cost Efficiencies Lonza’s dedicated product management is a vital part of your product success. A product manager is your key contact providing continuous effective communication throughout the product lifecycle. Lonza’s product management provides an integrated approach across the production value chain: from R&D to logistics; from quality assurance to manufacturing. You will be pleased with the ease of project administration without compromising efficiency or quality. Core Competency: Systematic Technology Transfer Through systematic and closely regulated operational and documentation processes, managed by dedicated product managers, we design and implement seamless technology transfer from your facility to our development and manufacturing sites. To date, we have transferred numerous clinical and commercial production processes. These transfers have covered scale-up factors from 5 to over 100 and scales ranging from 40L to 15,000L.