Early Development Bioconjugate Services
Start De-Risking your Bioconjugate Development Early
The rapid emergence of novel bioconjugation technologies provides exciting opportunities for enhanced therapeutic profiles, but also renders the development and manufacturing of bioconjugates increasingly complex.
Lonza offers early-development services to assist customers with tailoring bioconjugate development specifically to therapeutic needs and to streamline process development and manufacturing. Customers benefit from an integrated platform combining selected state-of-the-art bioconjugation technologies, drug-linker synthesis, and protein expression with over a decade of experience in the manufacturing of clinical and commercial bioconjugates.
Key attributes of our services are early de-risking and optimization of your protein scaffold, and a toolbox of robust and scalable bioconjugation technologies that will ensure a seamless transition to clinical and commercial manufacturing.
Access Robust and Scalable State-Of-The-Art Technologies with Our Conjugation Toolbox
We have established a comprehensive toolbox comprised of state-of-the art conjugation methodologies that can be applied to build bioconjugates from various protein formats.
We closely work with selected partner companies to make innovative bioconjugation technology available to our customers. Each of the technologies is assessed in our labs for its robustness, scalability, and ease of transfer into GMP.
Reach out to us if you want to learn more about our conjugation toolbox or if you are a technology provider who is interested in making the technology available to various drug developers.
Learn more about the Lonza Bioconjugation Toolbox and our partners here.
The conjugation toolbox is complemented by payloads and other small molecule technologies and our protein design, optimization and expression services located in Cambridge, UK.
Our technology-providing partners
Each of our partners´ technologies addresses different challenges encountered in bioconjugate drug development to provide tailored solutions to our customers.
We are continuously expanding our toolbox with novel approaches and are open to collaborate. Reach out to us if you would like to make your technology available for various drug developers.
Singzyme's technology uses Peptide Asparaginyl Ligases (PALs) to conjugate active drugs or any other payloads to proteins.
- Site-specific conjugation (precise DAR, homogeneous product)
- One-step, fast conjugation
- Minimal footprint on final product
- Broad applicability : antibodies, fragments, protein-RNA/DNA conjugates, Protein-protein conjugates, etc.
McSAF provides with McSAF Inside® cysteine rebridging technology platform using native interchain disulfides.
- Native Proteins can be used
- Site-specific, 100% chemical process
- Applicable to different IgG subtypes, mAb fragments, proteins and peptides, linkers and payloads
- Synthesis of drug-linker straightforward
AbTis offers with AbClick® a cyclic peptide that binds to the Fc domain of IgGs, leading to a traceless proximity driven reaction of a linker to the mAb.
- Native antibodies can be used
- Site-selective conjugation with high yield
- Stable isopeptide bond is formed
- Applicable to different IgG subtypes
Cristal Therapeutics provides with CliCr® a powerful metal-free click chemistry reagent.
- More hydrophilic than other strained alkynes
- Highly selective, site-specific conjugation
- Short reaction times compared to other marketed copper-free click reagents, hence attractive CoG
- High stability in a broad range of reaction conditions; with tunable realease of payload if preferred
Simris offers highly potent cyanobacterial toxins which can be functionalized for easy conjugation and tailored structurally. Simris’ microcystin platform, for example, offers a pool of analogues with:
- Huge structural diversity (> 300 natural structural analogs), easy to modify for conjugation, lead optimization and labeling
- Comprehensive in-vitro and in-vivo data are available, incl. mode of action (MoA) and structure-activity-relationship data
- In-vitro/in-vivo proof-of-concept for diverse microcystin-ADCs revealing high efficacy and tolerability (MTD)
- Excellent safety profile for ADCs: only expressing toxicity after active cell uptake; non-toxic for healthy tissues.
Bioconjugate Design & Lead Generation: Our Workflow to Realize your Drug Concept
- In a joint meeting with you, we’ll discuss overall bioconjugate architecture and conjugation approaches are discussed, considering both product requirements and feasibility for development.
- Initial runs are performed to establish the process on lab scale, optimize the most important parameters and testing analytical methods.
- A panel of bioconjugate variants can be generated for Proof-of-Concept studies (typical outputs: 10 – 20 mg per variant).
- Larger amounts can be generated, e.g. for animal studies, by running a first scale up to supply g-amounts of your bioconjugate.
De-Risk your Bioconjugate Development Journey to the Clinic
- With +70 projects from preclinical development to commercial scale manufacturing and +300 GMP batches per year, we are uniquely positioned to help you on your drug development journey.
- From the earliest development phase, manufacturability and facility fit are considered in order to avoid re-optimization and repetition.
- Reducing the number of interfaces and technology transfers, ultimately de-risks and streamlines the path to IND and commercialization.
Our locations
Location where this service is provided
Visp, Switzerland
Founded in 1897, Lonza today is a dedicated strategic manufacturing partner to the healthcare industry, working with customers in the pharma, biotech and nutrition markets. Visp remains our largest site in a global network of more than 30 sites and one of the most significant for research and 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 Ibex® Solutions pioneering services offering. Ibex® Solutions enables customers to accelerate their path throughout the complete biopharmaceutical lifecycle - from preclinical to commercial stages, from drug substance to drug product, all in one location.