Bioprocess and Biologics Development Services from Abzena

Description

We are a fully integrated biologics CDMO + CRO offering innovative drug discovery, development and manufacturing services, and advanced technology solutions that move medicines forward.

We deliver endtoend solutions for:
  • Monoclonal Antibodies (mAbs)
  • AntibodyDrug Conjugates (ADCs)
  • AntibodyOligonucleotide Conjugates (AOCs)
  • Radionuclide AntibodyConjugates (RACs) & Radionuclide DrugConjugates (RDCs)
  • Bispecific Antibodies (bsAbs) & Multispecific Antibodies (msAbs)
  • Fusion Proteins
  • Cytokines
  • Recombinant & Conjugate Vaccines
  • Nanoparticles
  • Biosimilars
Mammalian Cell Line Development:
  • We offer an integrated cell line development process, shortening timelines to IND enabling material, supported by using fast stable pools to generate earlystage material for characterization, preformulation, analytics and lead molecule selection.
  • For complex biologic programs, we deliver increased productivity through our AbZelectPRO™ platform, which combines our existing CHO cell line with ProteoNic’s premium expression vector technology 2G UNic.
  • We maintain biosimilarity, critical for the regulatory, by developing your biosimilar cell line using the originator cell type.
  • Applying our technologies and experience in proteomics, protein engineering, bioconjugation and formulation development, we design novel subunit and conjugate vaccine candidates.
  • We have the flexibility and expertise to apply our processes to other proprietary host cell lines including; SP20, NS0, PER.C6, CHOZN, CHO BIOP3.
  • Streamline your biologics development program with our GMPcompliant cell line characterization approach.
    • Process Development capabilities include:
    • Experience with multiple mammalian cell types including CHO, ABZCHO K1, sp2/0, yp2/0, and NSO
    • Experience beyond mAbs including fabs, ADCs, oligonucleotides, nanoparticles, bispecifics, fusion proteins, vaccines, viruslike particles, enzymes, and bioconjugates Transfer verification optimization of your process
    • Design of statistical experiments to optimize media feeds and growth conditions
    • Scale down fed batch and perfusion production models
    • Robotic systems from 250ml to manufacturing scale at 2K
    • High cell density and titer optimization
    • Bench scale process characterization and validation
    • Coordination with Analytical Method Development (AMD) to determine quality attributes
    Downstream PD capabilities include:
    • Harvest optimization through depth filtration or combined with continuous centrifugation
    • Chromatography steps utilizing all models e.g., affinity, ionexchange, hydrophobic interaction, metal affinity, etc.
    • Column chromatography from 1 ml through 10 L of bed volume
    • Filter sizing studies
    • Viral filtration determination and viral clearance validation
    • Stability on process intermediates and process hold steps
    • Critical Quality Attributes (CQAs) and Critical Process Parameter (CPPs) validation