Biologics Businesses

We serve our customers throughout the product lifecycle – for all clinical manufacturing needs and through the transition of their products to commercial manufacturing.

Integrated Offerings in Pharma & Biotech – Biologics
Integrated Offerings in Pharma & Biotech – Biologics (graphic)

Commercial Manufacturing

Lonza is a leading commercial contract manufacturing provider for biopharmaceuticals. Our offerings include the manufacture of commercial drug substance of monoclonal antibodies (mAbs) and recombinant proteins from mammalian cell culture and microbial fermentation. Currently our manufacturing product portfolio includes products that represent essential active pharmaceutical ingredients (APIs) for life-saving medicines, including cancer treatments and orphan drugs for rare diseases where no alternative treatment exists.

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commercial large-molecule medicines

Production scales from

2,000–20,000 L

across four existing state-of-the art cGMP manufacturing sites: Portsmouth, NH (USA), Porriño (ES), Tuas, Singapore (SG) and Visp (CH)

Today Lonza’s commercial mammalian manufacturing offerings have a global footprint, comprising production scales from 2,000 L to 20,000 L across three existing state-of-the-art current good manufacturing practice (cGMP) sites: Portsmouth, NH (USA), Porriño (ES) and Tuas, Singapore (SG). Furthermore, we are adding new capacity in our Ibex Solutions biopark in Visp (CH), with the aim of bringing flexibility and the most-fitting scale of capacity to fulfill different market segments’ and customers’ needs.

Our commercial microbial manufacturing business currently operates from three plants at one location in Visp (CH), with a customer base that is a healthy mix of large, mid-size and emerging pharmaceutical companies.

Recent pipeline development in novel molecules such as antibody fragments, protein scaffolds and bioconjugates require a toolbox of solutions and our experience handling complex molecules. Our know-how and platform technologies enable our customers to define their own tailored solution from a full range of services. Our GS Xceed® Gene Expression System for mammalian expression and our XS® Technologies for microbial expression include well-established processes for efficient, scalable and regulatory-compliant commercial manufacture. In addition, our Ibex Solutions further help to mitigate customers’ capital expenditure investment risks; and we have the capabilities to construct dedicated facilities for specific manufacturing needs.

Our commercial track record and proven expertise over two decades have enabled us to gain a broad accreditation from global health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), among others. We pride ourselves on being the market leader for highly customized, reliable and innovative solutions to meet customers’ needs.

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For further information about our mammalian cell-culture capabilities for large-molecule drug substance, as well as for descriptions of Lonza’s mammalian cell culture facilities, including Portsmouth, Porriño and Singapore, please visit our mammalian manufacturing webpage. / For further information about our microbial fermentation capabilities, please visit our microbial development and manufacturing webpage. Explore Lonza’s worldwide sites by location via our 360° Virtual Tours.

Clinical Development and Manufacturing

Lonza’s Clinical Development and Manufacturing business focuses on the early phase of drug development, from late discovery through clinical trial supply. In 2018 we offered a broad portfolio of drug substance and drug product development services and clinical supply manufacturing across the mammalian and microbial modalities.

>305

large-molecule clinical development programs

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sites: Slough (UK), Hayward, CA (USA), Cambridge (UK), Visp (CH), Basel (CH) and Singapore (SG)

Our bioconjugate team in Visp (CH) is one of the industry leaders in process development and current good manufacturing practice (cGMP) manufacturing of clinical and commercial bioconjugates, including antibody drug conjugates (ADCs). The team’s track record encompasses manufacture of several bioconjugate constructs, including customers’ novel payload, linker and conjugation technologies.

Our teams work with customers to ensure reliable delivery of integrated, innovative and value-adding gene-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.

Late Discovery Services

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 in vitro, cellular immunogenicity screening, and our antibody humanization and deimmunization services.

Our Sentinel APART Platform serves as a tool for antibody aggregation prediction and re-engineering, and our manufacturability assessment service is used to help predict and mitigate manufacturing risk. Early-stage customers also benefit from our mammalian and microbial-based Lightpath material supply services for their research and proof-of-concept studies. We also complement these services with developability assessment services to support our customers’ lead candidate selection.

More information on our late discovery services is available online.

Protein Expression

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.

Process Development or Transfer

Following creation of a new cell line or strain, we engage in a program of process development and scale-up studies that creates a robust process suitable for transfer to current good manufacturing practice (cGMP) sites. Once a process has been established, we can manufacture products to support not only preclinical activities, but also clinical trial material. In addition to developing a process at Lonza, we are also able to transfer into Lonza many product and process technologies that have been developed by our customers.

Parental Drug Delivery

Lonza’s Drug Product Services (DPS) team in Basel (CH) focuses on parenteral dosage forms and offers solutions for customers developing therapeutic proteins, peptides, cell and gene therapies as well as small molecules that require a parenteral dosage form. These products are for injection and infusion for intravenous, subcutaneous and intraocular routes of administration.

Empty laboratory (mood picture)

The DPS team provides a complete portfolio of services for parenteral dosage forms, including formulation development, simulated clinical administration setup and testing, analytical method development and quality control, primary packaging and device design and integration, drug product process development, and manufacturing of parenteral dosage forms for stability testing, preclinical or clinical testing.

Parental Drug Delivery KPIs 2016 vs. 2018 (graphic)

Special services also include surfactant characterization and characterization of excipient degradation, extractables and leachables assessment, and container-closure integrity and device testing. Our experts have multiple years of experience in the development, manufacturing, testing and commercialization of parenteral dosage forms and related regulatory requirements; and they have extensively researched and published in this area. Our customers benefit from 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 processes and troubleshooting in pharmaceutical manufacturing.

The recent expansion of Drug Product Services in Basel (CH) contributes to Lonza’s gene-to-patient offerings.

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Our Clinical Development and Manufacturing global footprint of manufacturing facilities includes Slough (UK) and Cambridge (UK), Hayward, CA (USA), Basel (CH) and Tuas, Singapore (SG), for mammalian projects, and Visp (CH) for mammalian, microbial and bioconjugates projects. Explore Lonza’s worldwide sites by location via our 360° Virtual Tours. For further information about Epibase®, Sentinel APART, GS Xceed® Gene Expression System, as well as our development and manufacturing capabilities for large-molecule drug substance and drug products, click here.

Highlights and Initiatives 2018

Lonza’s biological businesses performed strongly in the reporting year. The Commercial Mammalian and Microbial Manufacturing team continued to benefit from a solid customer base and strong demand, enabling the business to secure additional contracts for the mid- and long-term.

Lonza Biologics’ Global Footprint and Investments
Lonza Biologics’ Global Footprint and Investments - world map (graphic)

The year 2018 saw substantial investment in the Portsmouth, NH (USA) site, including mid-scale biologics. We introduced new mid-scale assets for commercial mammalian manufacturing to meet strong demand and complement existing small- and large-scale assets within the Lonza network. Lonza is installing multiple 6,000 L bioreactors at the site to meet existing and new customers’ needs, with construction starting in late 2018. The reactors were designed from the outset with advanced in-line testing and automation capabilities.

The new facilities have been designed to ensure reliable delivery of innovative medicines. With a strong focus on automation, Lonza is implementing full-suite process analytic technology (PAT) and advanced multi-variate analysis (MVA) to help ensure consistent performance. This hybrid facility also incorporates state-of-the-art, single-use technologies for simplified processing.

« These new facilities in Portsmouth have been designed specifically to deliver innovative medicines for our customers and their patients. They will be enabled by cutting-edge technology developed with our R&D team and the decades of expertise at our Portsmouth site. »

Marc Funk, COO of Lonza Pharma & Biotech

The operations of our Tuas, Singapore (SG) single-use bioreactor facility developed as planned in 2018. The first Singapore 2,000 L batch was successfully released in November. The batch was supplied under the strategic manufacturing agreement with one of our customers for their therapeutic antibody. Lonza performed cell-line development and provided clinical supply for this antibody at our Slough (UK) site and used our established GS Gene Expression System®. The process was subsequently transferred into 2,000 L scale disposable bioreactors at Lonza Singapore, which will continue to manufacture material for our customer’s ongoing clinical trials and, if the antibody is approved for commercial use, will also provide the commercial supply.

Demand for Lonza’s development services and clinical manufacturing in all technologies remained strong, further fueled by increasing pressure to shorten time to the clinic and to the market, which creates new fast-track approval pathways for regulatory authorities. Therefore, we are expanding our clinical development services and manufacturing capacity in Slough (UK).

Earlier than expected, our Clinical Development and Manufacturing team saw full changeover to Lonza platforms, processes and technologies at our Hayward, CA (USA), facility, which was acquired in September 2017 from Shire. The first customer batches were released already in the third quarter of 2018, and the transfer of new and existing customers to the Hayward site continues to progress well.

Shaping the Future of Biomanufacturing with Ibex™ Solutions

In September 2018, Lonza expanded our Ibex Solutions facility in Visp (CH), with two new, innovative packages – Ibex Design and Ibex Develop. The two new offerings are designed to meet the evolving needs of biotech companies with antibody therapies, from the preclinical stage through to commercialization. This expansion includes drug substance development and drug substance and now also drug product manufacturing. Together with the existing Ibex Dedicate offering that targets companies in later stages, the new investment allows Lonza’s customers to benefit from a complete product lifecycle management at one site. Advanced technology, single-use bioreactors and improved platform processes are applied to shorten time to clinic and to market, while innovative business models are expected to increase predictability. The innovative offerings received positive feedback in the market. Construction at the Visp (CH) site is well underway, and the Lonza-Sanofi joint venture (the first Ibex Dedicate) and the Ibex Design and Ibex Develop (one wing of one building) will become operational from 2020. The full Ibex Solutions facility is a generational project.

More information on our Ibex Solutions is available online.

« We are capitalizing on attractive organic growth opportunities, like the recently announced expansion of our Ibex™ Solutions offerings in Visp (CH) that provide clinical development and manufacturing services along the whole value chain and now include fill and finish. »

Richard Ridinger, CEO of Lonza

Ibex Design

Ibex Design covers the early stages of creating a new biologic, from gene through to clinical phase I. The offering comprises a pioneering fixed-price gene-to-vial package with terms under which Lonza can deliver drug products based on at least 1 kg drug substance within 12 months – shortening timelines from receipt of gene sequence to Investigational New Drug (IND). This package also includes the reservation of a manufacturing slot for clinical resupply. Ibex Design allows aspiring companies to start clinical trials earlier while reducing uncertainty. The result strengthens our capabilities from the early stages of drug development all the way through to commercialization. It will help biotech companies deliver life-saving medicines to patients faster.

Ibex Develop

Ibex Develop helps companies seamlessly and rapidly transition from clinical phase II to commercialization. Co-location at one site eliminates the need for tech transfers, and accelerates the path to market. This offering enables biologics license applications (BLAs) to be submitted within 22 months from the start of process characterization. Eliminating the need for tech transfers, allowing process optimizations and creating operational efficiencies are all expected to accelerate the path to market.

Ibex Dedicate

With Ibex Dedicate, a fully customized commercial supply solution that is exclusive for our customers’ products, Lonza is able to offer complete product lifecycle management in one site. A pre-built wing and faster ramp-up could save our customers up to 30 months total time to market. Ibex Dedicate allows our customers to delay their capacity build decisions and better manage investment risk. Moreover, flexible ownership and operating models give our customers freedom of choice, in combination with a technology-agnostic solution that can be tailored to suit mammalian and microbial production, vaccines and cell and gene therapies.

Ibex™ Solutions facility in Visp (CH) (photo)

Gold buildings: under contruction; operational from 2020

Cell and Gene Technology

Cell and gene therapies are seen as the new frontier in medicine. The field of cell and gene therapy has the potential to transform the way patients diagnosed with cancers or genetic diseases can be treated. These novel drug candidates provide drastically improved patient outcomes and, in some cases, may even prove to be curative. With our comprehensive offering that spans allogeneic and autologous cell therapies, as well as viral vector gene therapies, Lonza is at the forefront of supporting this new frontier.

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centers of excellence: Houston, TX (USA), Maastricht / Geleen (NL), Portsmouth, NH (USA) and Singapore (SG)

However, the manufacture of such medicines poses new challenges that are unique to each of the sectors we serve in cell and gene therapy. For example, the small, patient-scale batch sizes for autologous products require scale-out approaches to meet commercial demand for certain larger indications. Furthermore, getting these drugs to patients around the globe may present logistical challenges. For allogeneic cell therapies and viral-vector gene therapies, other challenges exist, such as scale-up to increase batch sizes and treat more patients per batch. Today the cost of production still represents a major hurdle on the way to the market. New technologies are needed that enable robust and efficient manufacturing and yield replicable high-quality medicines.

Enabling Technologies Offered by Lonza Cell and Gene Technology
Enabling Technologies Offered by Lonza Cell and Gene Technology (graphic)

By developing innovative technologies and platforms that industrialize the manufacturing of cell and gene therapies, our goal is to enable developers to make these therapies mainstream and commercially viable. With decades of experience in cell processing and as an industry leader in process development and manufacturing of cells and viral vectors under current good manufacturing practices (cGMP), Lonza is well positioned to achieve this goal. Our broad service offerings – combined with a global footprint that spans the United States, Europe and Asia – enable us to support our clients throughout clinical development and commercial production.

At our new Houston, TX (USA) facility, the Lonza team offers development and cGMP services for cell and gene therapies, including viral vector production. The range includes a wide selection of cell and virus types, such as T-cells, dendritic cells, pluripotent stem cells (PSCs), mesenchymal stem cells (MSCs) and adenoviral, adeno-associated virus (AAV) and lentiviral vectors.

« We really want anyone we work with to be genuinely engaged in the purpose. I do not consider Lonza a vendor; I consider Lonza a partner. I do not consider this a manufacturing facility; I consider this a house of hope. »

Nick Leschly, CEO of bluebird bio at Lonza Houston Grand Opening, 10 April 2018

We aim to be the industry partner of choice in this process and to help our customers drive pioneering therapies to the market by investing in enabling technologies and using our expertise to support the development and commercialization of new, innovative therapies. Our scientists and engineers bring decades-long development experience across a broad spectrum of cell types and technologies. This expertise builds the backbone of an extensive service offering and provides a tailored approach to analytical development, manufacturing and regulatory services.

Cell and gene technology is one of the key pillars for Lonza Pharma & Biotech’s overall strategy: Delivering the Medicines of Tomorrow, Today®.

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Additional information about our services, such as process development, cGMP manufacturing, assay development, analytical and all other related services, is available on our cell and gene technology website. Some of our facilities can also be viewed on our 360° Virtual Tour.

Highlights and Initiatives 2018

During the reporting year, a key focus at Lonza was on the development of our cell- and gene-therapy capabilities, an area of high potential for the future of medical treatment.

The opening of the world’s largest dedicated cell-and-gene-technology manufacturing facility in Pearland, Greater Houston, TX (USA) in April 2018 was a major step forward for Lonza. The expanded capabilities were well received, and the transfer of existing and new customers into the facility progressed as expected during 2018. At 300,000 square feet (27,870 square meters), the site is growing and recruiting highly qualified personnel to meet market demand.

Lonza announced in February that it was to establish centers of excellence for cell and gene technology to support and accelerate the growth of this priority area for the company. The Lonza sites in Pearland and in Geleen/Maastricht (NL) will offer a fully integrated range of cell-and-gene-therapy services, including process and analytical development, clinical product supply and commercial product supply. Lonza’s facilities in Portsmouth, NH (USA) and Singapore (SG) will continue to serve as clinical and commercial manufacturing sites. The centers represent a global network spanning the United States, Europe and Asia and provide flexible solutions to support fast-track programs.

Lonza is actively investing in key innovation technologies in viral vector manufacturing, allogeneic manufacturing in 3D bioreactors and autologous manufacturing in the Cocoon system. In 2018 we further strengthened our commitment to drive the next generation of manufacturing patient-specific and personalized therapies with the acquisition of a controlling stake in Octane Biotech, with the right to acquire full ownership of the Cocoon technology. The increase in equity share will allow us to further develop the technology necessary to support the growing need for scalable autologous manufacturing.