Development and manufacture of small molecules and biopharmaceuticals


Lonza was founded in 1897 and shortly thereafter transformed itself from an electricity producer to a chemical manufacturer. Today we are one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Visp remains our largest site and one of the most significant for R&D, 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 pioneering services offering: Ibex Solutions. Ibex solutions span the complete biopharmaceutical lifecycle - from preclinical to commercial stages, from drug substance to drug product, all in one location.


 

  • Flexible Manufacturing to Meet Every Stage of Product Development


    At our Visp site, we provide customized development, cGMP clinical and commercial-scale production services for API and their intermediates. Commercial scale production services are typically provided based on three scenarios:

    • Integrated services from concept or phase I through to commercialization
    • Late-phase clinical transfers often to facilitate an accelerated pathway to market
    • Second sourcing to better ensure security of supply

    We maintain a dedicated launch facility for the cGMP production of launch-scale API. Rapid technology transfer into the launch plant from our small-scale plants is facilitated by adherence to strict quality standards at all stages of product development. Integrated facilities ensure rapid scale-up and commercialization of drug substances.

    Kilo lab 10–30L vessels
    Small scale plant 16 reactors (up to 250L)
    Launch / mid-scale plant 57 multi-purpose reactors (250–3000L)
    Commercial scale 6 multi-purpose reactors (10000L)
    HPAPI plant 6 reactors (10000L)
    ADC plant 10 reactors (600L)
    Continuous flow manufacturing

    Our API facilities are equipped with state-of-the-art equipment, incorporating years of process optimization, and are supported by multi-purpose plants for starting materials and intermediates.

    To achieve robust and efficient process qualification for scale-up, we use modern tools such as in-process sampling and controls, automated workstations, statistical software, and reaction calorimetry. We focus on cost-competitive manufacturing on an industrial scale by minimizing the number of unit operations of chemical processes and through specialized QC/QA approaches.

    The extensive capabilities and phase-appropriate plant network at Visp are augmented with our Nansha (CN) site, providing increased flexibility in meeting your program’s specific needs. Our manufacturing sites adhere to stringent global quality standards, with the Visp site having an excellent regulatory inspection record inclusive of FDA, SwissMedic, MHRA, ANVISA (Brazil), KFDA (Korea) and Taiwan FDA.


    Specialized Capabilities / Highly Potent API Development and Manufacturing


    Our launch and large-scale production facilities at Visp provide specialized capabilities and expertise across a full range of chemical synthesis.

    • Contained environments (isolation, solids handling)
    • Low-temperature modules
    • Solvent recovery plants
    • Reactor volumes from 160-16000L
    • Low (-90C) to high (650C) temperature reactions
    • High pressure reactions (80 atm)
    • Back-integrated (diketene, ketene, HCN, acetylene)
    • On-site process development services and analytical support

    The Visp site also serves as our Center of Excellence for HPAPI development and manufacturing, with dedicated HPAPI small-scale to commercial-scale production facilities and high containment trains in place.

    Specialized HPAPI R&D labs and small scale plant are in place support early phase clinical to low volume commercial production of potent compounds (to OEL ≥ 1ng/m3) and ADC payloads. Investment is ongoing to expand HPAPI capacity at all scales and to handle extremely high potent compounds to 1 microgram/m3.

    R&D and lab-scale 8 production lines (10–50L)
    Small / mid-scale 15 production lines (160–2500L)
    Commercial scale 3 production lines (4000–10000L))

    Utilizing this combination of technology, infrastructure and expertise, we provide you with seamless, flexible HPAPI development and manufacturing tailored to your specific needs and resulting in reduced program timelines, complexity and risk. Contained particle engineering and specialized drug product development and manufacturing for low dose / HPAPI applications (sterile fill/finish, liquid-filled hard capsule and soft gels) are also available within our plant network.

  • Microbial-derived biopharmaceutical development and manufacturing


    Our Microbial site is located in Visp (CH). The site hosts several multi-product cGMP manufacturing and development suites for manufacturing of microbial-derived biotherapeutics. Lonza’s microbial center of excellence supports programs for a number of molecule types including new molecular formats such as antibody fragments, mimetic`s, and novel scaffolds. Capabilities also include product and process characterization as well as validation studies in support of Biological License Applications. Manufacturing for early clinical supply as well as commercial manufacture including conjugation technologies (e.g. pegylation reactions and polysaccharide conjugations) are established, ongoing operational practices on site.

    The cGMP facilities house cell banking, production (fermentation and purification) and laboratories for quality control and process development. Manufacturing assets include 70L, 1,000L, and 2 x 15,000L stainless steel reactors as well as 50L, 200L and 1000L single-use reactors. Furthermore, the facilities include associated inoculum suites, media preparation areas and primary recovery equipment (comprising continuous centrifuge for cell removal, depth filtration and concentration equipment).

    Upstream capabilities
    • Microbial Fermentation Processes (e.g. E.coli and non-E.coli as well as P. pastoris)
    • Four separate production lines with fermentation scales of 1x 70L, 1x 1`000L and 2x 15`000L (stainless steel)
    • Single use production bioreactors: 50L, 200L and 1000L
    • Inoculum labs for independent small scale culture
    • Disc stack centrifuges, nozzle or discharge type
    • Max homogenization pressure: ≤1’200 bar
    • Large scale urea buffer handling available
    • MF/DF systems (e.g. for cell removal)
    • Heat extraction
    • Depth filtration capability
    • Room classification: ISO 8
    • Bio safety level: up to BSL-2

    Downstream capabilities
    • Four separate purification suites with column dimensions up to 200 cm in diameter
    • UF/DF systems up to 80 sqm
    • Buffer preparation capability up to 12’000 L
    • Temperature: ≤ 10 °C
    • Room classification: ISO 7 with final fill ISO 5 in ISO 7

    Analytical development and testing
    • Technology Transfer towards cGMP Manufacturing
    • DoE based development for improved sensitivity
    • Stability studies
    • Reference standard characterization
    • Validation, formal transfer of methods

    Enabled by:
    • HPLC & UPLC Systems (UV, DAD, CAD, MALS, Fluorescence)
    • UV/VIS and Slope Spectroscopy
    • Protein Content (BCA, Bradford, Lowry)
    • CE-SDS, CZE, cIEF
    • SDS-PAGE and Western Blotting
    • qPCR, Picogreen and/or threshold
    • Immunoassays – ELISA (Titer, HCP, Potency)
    • Traditional Approach on MTPs
    • High Throughput (TECAN Freedom Evo)
    • High Sensitivity Protein-PCR (ProteinSEQ™)
    • Bioburden and Endotoxin

    Quality systems and regulatory inspections


    Visp operates under a global quality management system which complies with internal policies as well as with national and international guidelines and regulations. Since 2003, the site has hosted 22 GMP / PAI inspections. Inspections included regulatory authorities such as the FDA, EMEA, Swissmedic, Health Canada and others.

  • Bioconjugate Biopharmaceutical Development and Manufacturing


    A complete offering for the development and manufacture of bioconjugates including Antibody-Drug Conjugates, PEGylated proteins, and vaccines. Our end-to-end offering simplifies the value chain by manufacturing all intermediates, drug substance and drug product under one quality system and will accelerate the timeline to the clinic or the market.

    Bioconjugates capability
    • Process Development and optimization for novel and platform conjugation technology
    • Analytical method development/optimization/qualification/validation
    • Process characterization/qualification/validation studies
    • Semi-synthetic/synthetic payload and linker manufacturing
    • Clinical phase and Commercial manufacturing suites with both glass/stainless steel or single use equipment
    • Multiple scale dedicated chromatographic columns both pre-packed and on site packed
    • Dedicated suite options through our Ibex™ service offering

    This facility is our center of excellence for bioconjugates and includes, multi-product cGMP manufacturing and development facilities for all product phases including launched. Capabilities also include product and process validation studies in support of Biological License Applications (CMC Section). The site supports manufacture for early clinical supply as well as large scale commercial manufacture.

    Analytical development and testing
    • Method development, transfer, qualification and validation
    • Co-validation of drug substance and drug product analytical methods
    • Reference standard characterization and Biochemical Comparability
    • Protein and impurity characterization & elucidation of structure
    • Platform methods for impurity, purity and identification
    • Bioassay / Activity assay development, transfer, qualification & validation
    • Stability studies for drug substance and product

    Quality Systems and regulatory inspections


    Visp operates under the global quality management system which complies with internal policies as well as with national and international regulations. Since 2012, the site has hosted 22 GMP / PAI inspections for both monoclonal antibodies and recombinant proteins. Inspections included the FDA and EMA among other regulatory authorities across the globe.

  • Ibex™ Solutions


    Ibex™ Solutions consist of three CDMO offerings: Ibex™ Design, Ibex™ Develop and Ibex™ Dedicate. The variety of offerings provide the flexibility of a complete program - from gene to drug product, or the option to drop in at a later stage depending where you are in your journey.

    Ibex™ Design is a pioneering gene to vial package delivering drug product for your clinical trials within 12 months. Also included is a manufacturing slot reserved for your clinical resupply needs.

    Ibex™ Design capabilities: Highly automated facility with single-use technology

    Development labs Drug substance manufacturing Drug product manufacturing
    • Cell line construction
    • Cell banking
    • Process development
    • Non-GMP bioreactors
    • Single-use bioreactors from 1000L to 2000L
    • Expansion capacity available
    • Liquid and lyophillized vial line for 5L to 500L batch size of clinical and launch supplies
    • Extension space for global commercial supplies

    Ibex™ Develop accelerates market readiness and can help you achieve BLA submission in 22 months. It offers tailored capacity to flexibly reach your clinical and commercial expansion requirements.

    Ibex™ Develop capabilities

    Development labs Drug substance manufacturing Drug product manufacturing
    • Pilot lab for tech transfer and non-GMP production
    • Single-use bioreactors from 1000L to 2000L
    • Expansion capacity available
    • Liquid and lyophillized vial line for 5L to 500L batch size of clinical and launch supplies
    • Extension space for global commercial supplies

    Ibex™ Dedicate is technology agnostic supply solution that helps you save up to 30 months-time to market and control investment risk with tailored business and ownership models.

    Tailored manufacturing for a dedicated supply

    Suites
    • Customer or technology specific suites
    • Consist of 1 up to 9 units (entire wing)
    Manufacturing wings
    • 3 floors of each 3000m2, each floor can be divided into 3 units
    • A total of 9 units per wing
    Manufacturing complexes
    • 2 manufacturing wings
    • 1 office section, 1 gowning section
    • 1 utility section, 1 headblock with additional labs and offices
    Lonza biopark
    • 5 manufacturing complexes
    • Central utility building, central buffer and media
    Visp site
    • Site infrastructure and site utilities
    • Warehousing and logistics

    Your benefits

    • High-responsive capacity in a dedicated facility
    • Tailored solution for your product, from facility design and staffing to the technology, scale, and business models
    • Flexible ownership and operating model. For example, we can deploy trained staff, train your staff, and take over operations of your facility

    Quality systems and regulatory inspections


    Visp operates under a global quality management system which complies with internal policies as well as with national and international guidelines and regulations. Since 2003, the site has hosted 22 GMP / PAI inspections. Inspections included regulatory authorities such as the FDA, EMEA, Swissmedic, Health Canada and others.