ADC：从概念到商业化

An end-to-end ADC solution that simplifies thevalue chain and accelerates time to clinic Charles JohnsonSenior Director, Commercial Development, Lonza Advanced SynthesisRaphael FreyDirector, Commercial Development, Lonza Advanced SynthesisPierre LandaisDirector, DP Clinical Offering, Lonza Integrated Biologics Lonza has been active in the antibody-drug conjugate (ADC) space since the early days of the categoryin 2007, working on products such as Kadcyla®(trastuzumab emtansine), followed by multiple otherproducts over the years. The field has advanced significantly since then, with more than a dozen ADCsnow approved and more than 200 in various stages of preclinical and clinical development, driven byan expanding pipeline of new chemistries and emerging modalities[1,2]. In parallel, Lonza has continued to strengthen and expand itsscientific and technical capabilities. The company’s integratedoffering enables the development and manufacturing of awide range of ADCs, supported by centers of excellence in Eu-rope, North America and Asia. Leveraging a long-establishedbiologics platform, deep expertise in small molecule synthesis,and advanced drug product capabilities, Lonza is well posi-tioned to address the challenges involved in bringing thesehighly complex therapies to market. worked on more than 70 bioconjugation products in Visp, andnow makes more than 300 cGMP batches every year. Over thepast decade, the company has also significantly strengthenedits expert drug product teams across Visp, Basel, and Stein. Since the acquisition of Synaffix in 2023, the company has hadaccess to an industry-leading site-specific conjugation tech-nology, GlycoConnect®. Furthermore, GS Expression Systemsgive a robust and scalable system for mammalian expression.With everything under one roof, the supply chain has beensimplified significantly, creating many synergies as a productprogresses through the pipeline. For example, Lonza has now developed more than a dozenpayload-linker systems in Visp and Nansha. Since 2007, it has Lonza has experience with a wide range of conjugation tech-nologies. ADC designers are using an ever-wider range ofmodalities, and multiple conjugation methodologies are re-quired to cover the full spread of chemistries. Lonza expertscan help navigating this diverse technology landscape, andsuggest suitable designs and tools to achieve the desiredbioconjugate. The growing importance of ADCs in the market has led Lonzato invest in further capabilities and capacity. Newly designedmultiproduct suites, currently in the expansion phase, willhave capacities of up to 1,500L. These stainless steel assetsprovide high throughput for high-volume commercial prod-ucts. There will be three suites in the first phase, with the firstdedicated suite to be operational in 2027, and two furthermulti-customer suites will be online from 2028. This furtherderisks launch and commercial supply, and will give Lonzathe largest ADC capacity in the industry. Development and manufacturingcapabilities Access to manufacturing assets for bioconjugation on arange of scales is, again, critical, and Lonza is extremely wellequipped across the board. The company’s flexible designallows both cytotoxic and non-cytotoxic bioconjugates to behandled. Drug product – integrated drug substanceand drug product services Lonza offers end-to-end drug product manufacturing capa-bilities for antibody-drug conjugates. This is supported by acomprehensive suite of integrated drug product services,spanning early development through to commercial produc-tion (Figure 4). At the small scale, the company has a range of glass vesselsup to 10L, plus single-use 50L conjugation vessels. This allowsus to meet the needs of batches from tox studies through toPhase 1. The company’s drug product development capabilities areintegrated across the value chain, covering formulation, pro-cess optimization, and advanced analytical support. This in-cludes services such as particle identification, studies onextractables and leachables, and container closure systemdevelopment. Complementary testing services, including re-lease testing, stability studies and simulated clinical admin-istration assessments, ensure consistent product quality,performance and regulatory compliance throughout thedrug product lifecycle. At a larger scale, both stainless steel and single-use conjuga-tion vessels are available for batches up to 600L. With six fullyflexible suites, this covers both clinical and commercial prod-uct manufacture. In addition, Lonza has extended its overallcapacity with the addition of large-scale suites. These con-tain stainless steel vessels up to 1,200L, enabling the flexiblemanufacture of commercial product. Some of these large-scale suites are dedicated to specific customers, who benefitfrom flexible capacity. The information contained herein is intended for general marketing purposesonly. While Lonza makes efforts to include accurate and up-to-date informa-tion