PROCESS DEVELOPMENT

ABL has successfully translated >100 products and processes from the laboratory bench to the GMP suite.  Teams of development scientists are embedded in every ABL manufacturing facility, each specializing in a critical area of bioprocessing:

  • Upstream cell culture optimization and product yield
  • Downstream purification and product recovery
  • Assay method development, qualification & validation to measure product yield and activity

Optimizing and scaling biological processes seldom follow a linear path.  ABL scientists leverage the knowledge achieved over collective decades of experience to create efficient process development programs designed to maximize a successful transition to GMP compliance.

Learn more about ABL process development and contact us today to discover how we can advance your product to the clinic:

PROCESS DEVELOPMENT SERVICES AND CAPABILITIES

ABL routinely conducts upstream and downstream development studies for our clients – an essential step towards efficient design of cGMP-compliant manufacturing.   We draw on our manufacturing and quality expertise to design processes that optimize product yields and minimize regulatory risk.  Our technical approach incorporates the use of disposal, single use technologies to maximize flexible manufacturing capacities, reduce clean room turn around, and accelerate time to clinic. 

UPSTREAM

SERVICES

  • Host cell line screening and selection
  • Transfection optimization
  • Media screening, feed strategy
  • Cell growth dynamics
  • Adaptation to animal derived product-free, suspension-based processes
  • Bioreactor optimization and scale-up
  • End of Production (EOP) cell evaluation

DOWNSTREAM

SERVICES

  • Harvest and clarification studies
  • Resin screening and selection
  • Column cycling and aging studies
  • Reduction of process residuals
  • Scale down modeling for viral clearance

UPSTREAM

CAPABILITIES

  • Sartorius Stedim 50 L Biostat STR Bioreactor
  • PALL iCELLis Nano
  • Traditional Adherent Systems:
    o HYPERStacks®
    o Cell Factories
    o Roller Bottles
  • Multiple DOE studies in flasks & bench-top bioreactors

DOWNSTREAM

CAPABILITIES

  • GE AKTA Explorer, Pure and Pilot Systems
  • kSep – Single-use continuous centrifugation
  • TFF systems