Clinical Development and Licensing

AR_2016_Pharma-Biotech_210px.pngOur Clinical Development and Licensing (CDL) business focuses on the early phase of drug development, from late discovery through early clinical trial supply. We offer a broad portfolio of drug substance and drug product development services and clinical supply manufacturing across three modalities – mammalian, microbial and chemistry – and support both large- and small-molecule development.

For our customers in late discovery phase, our Applied Protein Services offering includes technologies and programs designed to mitigate risks, reduce attrition and improve the quality and safety of therapeutic proteins. These technologies include our Epibase® Immunogenicity screening services, our Sentinel APART™ Platform for antibody aggregation prediction and re-engineering and our Manufacturability Assessment Service for prediction of manufacturing performance.

When a lead candidate is selected, our industry-leading expression technologies, including the GS 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 out-licensed for use by our customers in their own facilities or used by us in a service mode.

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 both small and large molecules. Once a process has been established, CDL can manufacture not only products to support pre-clinical activities, but also early clinical trial material.

We have a global footprint of manufacturing facilities, including Slough and Cambridge (UK), Basel (CH) and Tuas, Singapore (SG) for our mammalian projects, Visp (CH) for microbial projects, and Nansha (CN) and Visp for our small-molecule programs.

The newest addition to our capabilities is our Drug Product Services offering. These services focus on parenteral dosage forms and include options for monoclonal antibodies, other biologics and small molecules that require a parenteral dosage form. Our offering includes formulation development and drug product analytical development and quality control, along with specialized services. Together with our existing development and drug substance manufacturing capabilities, this offering enables us to provide one-stop-shop service solutions for our customers.

In CDL 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.

Clinical Development & Licensing Overview 2016

In our Clinical Development & Licensing (CDL) business, we continued on our growth path in 2016. Several new products that use our GS Gene Expression System™ technology were approved, which brought the year’s total number of approved therapeutics to 31, representing 32% of all FDA-approved biologics in 2016.

Our reach into the early-phase small-molecule market continued to grow because of the healthy market for small biotech companies that are developing NCEs, as well as our broad capabilities in this area.

Lonza’s containment capabilities for handling Highly Potent Active Pharmaceutical Ingredients (HPAPIs) provide us an excellent market position as they allow us to handle the most-potent drugs currently being developed.

In October Lonza started operation of our new Drug Product Services laboratories in Basel (CH). Capabilities will focus on parenteral dosage forms for biologics, drug conjugates, peptides and small molecules for products for injection or infusion.

For further information about Epibase®, Sentinel APART™, GS 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.