Monoclonal Antibody Manufacturing

Monoclonal Antibody Manufacturing

As a cGMP contract manufacturing company, we focus on bio-production of clinical trial materials.  We specialize in manufacturing pre-clinical, phase I and phase II clinical trial materials for monoclonal antibody, antibody-fusion proteins and other recombinant protein based therapeutics for biopharmaceutical companies.  Currently, monoclonal antibodies are the most widely used form of cancer immunotherapy.

Some of our clients attach different drugs or toxins to a variety of monoclonal antibody types that are produced at our FDA registered cGMP facility, and then deliver to the targeted cancer cells as therapy during clinical trials. We have strong experience in commercial scale manufacturing as well of radiolabled antibodies used in diagnostic imaging of cancer.  The diagnostic radioactive markers attached to the monoclonal antibodies aid in the location of the cancerous cells within the body.

As a Biopharmaceutical contract manufacturer, we have produced various types of monoclonal antibody and recombinant proteins to be used in clinical trials for a variety of virtual, small and medium scale biotechnology companies. We can do it for you.

Biopharmaceutical Contract Manufacturing Capabilities:

  • cGMP production and purification up to 2,000 L scale for clinical trial or commercial products
  • Technologies that include Stirred Tank (batch and fed-batch), WAVE® and Hollow Fiber bioreactors
  • Protein Modification and Conjugation
  • Formulation and Aseptic Filling into vials
  • Process Development (both upstream and downstream)
  • Cell Line Optimization including re-cloning and amplification
  • Medium optimization studies and adapting cells to protein-free medium
  • Transfection, cloning and selection to create new cell lines
  • Analytical Method transfer, development and qualification
  • Pilot-scale (up to 200 L) bioreactor runs
  • Product Formulation Development

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