Bioconjugates, ADCs & Chemistry

Accelerate your timeline to the clinic or the market with our expertise in complex chemistry and bioconjugation services.

We are a leading, fully integrated bioconjugates & ADCs CDMO offering expert development and manufacturing services, and end-to-end solutions including our ThioBridge™ ADC development platform. Our bioconjugation process development group is purpose built for the optimization and scale-up of your ADCs and bioconjugates.

 

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Bioconjugates & Antibody-Drug Conjugates (ADCs) offer a complex development and manufacturing challenge. Abzena’s extensive bioconjugation experience and complete end to end solution simplifies the development process, and accelerates timelines to reach the clinic or market. Our specialized services for bioconjugates & ADCs provide:

  • Early de-risking & optimization
  • Process development & optimization
  • Formulation development
  • Analytical method development
  • Linker payload design & synthesis
  • Clinical to commercial manufacture

Specialized ADC, linker payload & bioconjugate services

Building on the unmatched expertise of our scientists, the IP we’ve generated, and our advanced facilities in the UK and US, you have everything you need to implement fully integrated commercial bioconjugation & ADC development and manufacturing programs.

We design and deliver tailored solutions for small molecule intermediates including high potency chemistry, linker payloads, payload-linker chemical intermediates, bioconjugation and antibody-drug conjugates (ADCs). We support partners with the design, synthesis and manufacture of payloads and payload-linker constructs for ADC and bioconjugation.

Leveraging our experience in the synthesis of payloads, linkers, and payload-linker chemical intermediate constructs we enable rapid generation of structure activity relationships (SAR) of various linker combinations with your new payloads. We identify the most suitable linker for your ADC profile.

 

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Bioconjugates & Chemistry Services

Moving medicines created with ADCs, bioconjugates and linker payloads forward is where we are at our best. This has made Abzena the leading, fully integrated, bioconjugate contract development and manufacturing services provider through to commercialization.

Linker Payloads

Supporting your candidate ranking and lead selection process, we determine the optimal design of linker payload architecture and profiling in a series of in silico, in vitro and ex vivo activity and safety assessments. We use a matrix evaluation and a developability approach to streamline the development, scale, and manufacture of your linker payloads.

Leverage our experience in the synthesis of payloads, linkers, and payload-linker chemical intermediate constructs to enable the rapid generation of structure activity relationships (SAR) of various linker combinations with your new payloads. Accelerating and de-risking the development and manufacture of your next-generation therapies, Abzena’s integrated approach supports the lifecycle of ADC discovery and development including the design and synthesis of payload-linker constructs for ADCs and bioconjugates. We identify the most suitable linker for your ADC profile.

Bioconjugate & ADC Design

We design and deliver tailored solutions for small molecule intermediates including high potency chemistry, payloads, linkers, payload-linker chemical intermediates, bioconjugation and Antibody Drug Conjugates (ADCs). We support partners with the design, synthesis and manufacture of payloads and payload-linker constructs for ADC and bioconjugation. To support lead drug candidate selection, we utilize our expertise in identifying and mapping the appropriate design space for the development of your complex ADCs.

Bioconjugate & ADC Development

Through the application of our developability assessments, we identify and de-risk your clinical candidates for development and ensure stage-specific milestones are met.

Complex Chemistry & Polymers

To meet your program goals, we develop novel and improve existing synthetic routes for complex chemicals, cytotoxins, payloads, linkers, HPAPI, biopolymers, and nanoparticles. We design, evaluate, and execute state-of-the-art synthetic strategies to deliver quality molecules with chiral integrity.

We offer product development and formulation programs to accelerate your timelines by leveraging our comprehensive in-house capabilities, technologies, and knowledge to deliver processes tailored to your molecule of interest.

We ensure the purity and integrity of your products by offering an extensive range of capabilities in the Analytical Method Development (AMD) and QC departments.

Analytics & Bioassays

Our approach to Analytics and Bioassays focuses on giving you all of the rapid insight needed to help make informed decisions earlier during your drug development journey.

Formulation Development

Our formulation development experience allows us to align your drug to your preferred target product profile (TPP) with a comprehensive range of packages including stable liquid and lyophilized formulations.

Process Development & Optimization

We can ensure seamless scale up through to commercial launch. That’s because our process development, optimization and manufacturing teams collaborate together to develop quality, commercially viable processes.

Clinical to Commercial Manufacturing

Supporting the robust scaling of your project from clinical through to commercial scale, we are dedicated to quality excellence, delivering small molecule intermediates including high potency chemistry, payloads, linkers, payload-linker chemical intermediates, bioconjugation and Antibody Drug Conjugates (ADCs).

Simplifying your project and de-risking technology transfer, we deliver specialized, integrated services across the lifecycle of your products.

De-risking bioconjugate & ADC development

Through a comprehensive technology transfer process, we deliver a successful scale-up model to ensure robust and consistent manufacturing process from clinical to commercial scale.

We collaborate with your team to de-risk the pathway to commercialization, ensure manufacturability, and deliver a quality medicine to the patient.

Our capabilities include:

  • Sartorius Sartoflow® Smart and Advance TFF systems for scale-up development and production in process development at volumes from 100mL – 50L and 0.1 – 2.1 m2 membrane surface area allowing for straightforward transfer to cGMP manufacturing
  • Sartorius Sartoflow® Alpha Plus SU and FlexAct® SU TFF systems for GMP manufacturing with volume ranges from 1 – 200L and up to 3.5 m2 membrane surface area
  • Full complement of AKTA FPLC™ systems in process development including an AKTA Pilot FPLC skid in process development capable of batch purification of more than 250g of bioconjugates in a day
  • AKTA Ready Gradient chromatography skid in GMP manufacturing suite capable of batch purification of greater than 1kg bioconjugate in a day
  • Conjugation reaction stirring capabilities include rocking motion mixers of volumes up to 50L and Sartorius LevMixer® pallet tanks from 50 – 1000L volume capacity

Our bioconjugation processes

Our conjugation processes are developed and transferred to our cGMP manufacturing team minimizing challenges seen during process transfers. We develop the most effective processes for manufacturing at toxicology, clinical, and commercial scale using quality by design (QbD) principles.

Our knowledge of cGMP manufacturing enables us to successfully transfer existing processes into our facilities or develop a new innovative process, when needed, to meet your program needs.

Our processes follow ICH Product Lifecycle guidelines which ensure a robust and well characterized scalable manufacturing process.

Utilizing analytics, we ensure the right product quality attributes for your program.

 

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ThioBridge™: ADC Development Platform

We continue to pursue advances in technology, processes and knowledge to keep ourselves and our customers at the forefront of innovation. Our agility and dedication mean we can streamline your program and mitigate project risk while producing groundbreaking treatments.

Our unique ThioBridge™ conjugation technology has been proven to enhance ADC development by overcoming issues with existing technologies in order to improve stability, potency, and efficacy. If you are looking to rapidly move your ADC program to its next regulatory or clinical milestone, access our latest information on ThioBridge™ today to learn how.

Fully integrated support across multiple modalities

We deliver end-to-end solutions for:

  • Monoclonal Antibodies (mAbs)
  • Antibody-Drug Conjugates (ADCs)
  • Antibody-Oligonucleotide Conjugates (AOCs)
  • Radionuclide Antibody-Conjugates (RACs) & Radionuclide Drug-Conjugates (RDCs)
  • Bispecific Antibodies (bsAbs)
  • Fusion Proteins
  • Cytokines
  • Recombinant & Conjugate Vaccines
  • Nanoparticles
  • Biosimilars