Heidelberg Facilities

 

European Manufacturing Capacity

With state of the art clinical and commercial manufacturing facilities across the United States, Europe and Asia, AGC Biologics has the capacity and flexibility to meet each customer’s individual manufacturing needs. Our manufacturing facilities are multi-process, engineered for unidirectional flow and segregated to produce multiple products at different stages of manufacturing in multiple parts of the facility. This increases the flexibility and number of manufacturing solutions available to meet clients’ rigorous manufacturing and quality needs. Right. On Time.

 

  • 10l_fermenter_00025.jpg
  • biomeva2017102_fermentation3_00027s.jpg
  • DSC04830.jpg
  • biomeva2017105_fplc_00108s.jpg
  • f662_1500l_00008A4Aco.jpg
  • diafiltration_00016.jpg
  • DSC04824.jpg
  • biomeva2016101_150_fermenter_11587.jpg
  • filtergehaeuse_00005.jpg

Heidelberg FACILITIES

AGC Biologics operates multiple cGMP manufacturing lines and a variety of scales in our Heidelberg, Germany microbial facility. The uni-flow design allows for capacity and technological flexibility, while ensuring compliance with current guidelines required for cGMP compliance. Whatever the challenge, AGC Biologics is your solution for clinical and commercial manufacturing.

 

Microbial Facility Equipment

MICROBIAL CELL BANKING AND STORAGE

  • Master cell banks and working cell banks
  • Production, characterization and storage
  • Up to 400 vials

PROCESS DEVELOPMENT

  • Upstream development
  • Downstream development
  • Analytical development
MICROBIAL MANUFACTURING  CAPABILITIES
  • Production of therapeutic proteins and DNA plasmids
  • Stainless steel fermenters with working volumes of 10L, 100L and 1000L
  • Continuous centrifugation harvest
  • Experience with E. coli, P. pastoris and other microbial expression systems
  • Production as secreted proteins, soluble intracellular proteins or inclusion bodies
  • Quality control release and stability testing