Clinical Development and Manufacturing Audited


Lonza's Clinical Development and Manufacturing (CDM) business focuses on the early phase of drug development, from late discovery through early clinical trial supply. In 2017 we offered a broad portfolio of drug substance and drug product development services and clinical supply manufacturing across three modalities: mammalian, microbial and chemical. And we supported both large- and small-molecule development.

In CDM we strive to work with our customers to reliably deliver integrated, innovative and value-adding gene-to-patient or target-to-patient custom solutions. We work in partnership with our customers to enable them to progress their candidates rapidly and effectively through clinical development in order to deliver medical treatments successfully to patients.

For our customers in late discovery phase, our Applied Protein Services offering includes technologies and programs designed to assess and mitigate risks, reduce attrition and improve the quality and safety of therapeutic proteins in a cost-efficient and timely manner. These technologies include our Epibase® in silico and human peripheral blood mononuclear cell- (PBMC-) based in vitro, cellular immunogenicity screening services, and our antibody humanization and deimmunization.

Our Sentinel APART™ Platform is used as a tool for antibody aggregation prediction and re-engineering, and our Manufacturability Assessment Service is used to help predict manufacturing risk. Early-stage customers also benefit from our mammalian and microbial based Lightpath™ material supply services for their research and proof of concept purposes. We also complement these services with pharmaceutical development services to support our customers' lead candidate selection. Get more information on our late discovery services.

When a lead candidate is selected, our industry-leading expression technologies, including the GS Xceed® Gene Expression System and XS™ Microbial Expression Technologies, are used to create commercially relevant cell lines or strains for protein expression. These technologies can be licensed out for use by our customers in their own facilities or provided by us in service mode. Get more information on our GS Xceed® mammalian expression technology or on our XS™ Technology for microbial protein expression.

Following creation of a new cell line or strain, we engage in a program of process development and scale-up work that creates a process suitable for transfer to a cGMP manufacturing facility. These process development activities support small and large molecules. Once a process has been established, CDM can manufacture products to support not only preclinical activities, but also early clinical trial material. In addition to developing a process at Lonza, we are also able to technology transfer into Lonza products and processes that have been developed by our customers. Get more information on our services:

Lonza's Drug Product Services (DPS) team in Basel (CH) focuses on parenteral dosage forms and offers options for monoclonal antibodies, other biologics and small molecules that require a parenteral dosage form. Our customers benefit from a seamless integration of pharmaceutical and drug substance development for rapid and reliable entry into the clinic and for robust late-stage development. In addition, Lonza DPS offers best-in-class analytical and specialized services for routine and troubleshooting in pharmaceutical manufacturing. Get more information on our Drug Product Services.

We have a global footprint of manufacturing facilities, including Slough (UK) and Cambridge (UK), Basel (CH) and Tuas, Singapore (SG) for our mammalian projects, Visp (CH) for microbial projects, and Nansha (CN) and Visp (CH) for our small-molecule programs. In October 2017 we acquired a new clinical manufacturing site on the West Coast of the United States in Hayward, CA. Get more information on our global sites.

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Highlights 2017
Innovation and Initiatives

For further information about Epibase®, Sentinel APART™, GS Xceed® Gene Expression System and XS™ Microbial Expression Technologies, as well as our development and manufacturing capabilities for small- and large-molecule drug substance and drug products, please visit the Custom Development and Manufacturing website from links provided above.