Linker PayloadsBioconjugates and Antibody Drug ConjugatesAnalytical Method DevelopmentFormulation DevelopmentProcess Development

Bioconjugates
& Antibody Drug Conjugates

Tailored For Your Product

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/sup> 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

Abzena’s bioconjugation process development group is purpose built for the optimization and scale-up of your ADCs and bioconjugates.

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Our conjugation 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.