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Process Development

A scientist in a white lab coat and blue gloves works on a computer in a laboratory, focusing on bioanalytical development. Various scientific equipment is lined up on the bench in front of him, and another person is seen working in the background. The lab is clean and well-lit with a clinical appearance.

Process Development Services

Pharmaron offers comprehensive process development services for various biotherapeutic molecules including monoclonal antibodies, bi-specific antibodies, fusion proteins and other recombinant proteins. Our cell line development platform can provide services from DNA sequence to cell banking.

Pharmaron’s holistic cell culture process development services cover media screening, feeding strategy definition, cell culture process parameter optimization, process characterization, process scale-up and technology transfer.  We can offer downstream purification process development, from resin screening to process optimization and technology transfer. In addition, our formulation and process development teams provide services to develop different dosage forms including liquid, lyophilized, or frozen drug products filled in vials, cartridges or pre-fillable syringes.

Capabilities

Developability Assessment
Process Development
Analytical Development and Quality Control
Pilot Scale Production
cGMP Drug Substance Manufacturing
cGMP Drug Product Manufacturing
Quality Assurance
A scientist in protective gear uses a pipette to transfer liquid in a modern laboratory setting. The workspace includes various tools, such as pipettes in a holder, beakers, and other scientific equipment, suggesting research or testing in progress, possibly related to genetic toxicology.

Cell Line Development

  • Gene synthesis and codon optimization
  • Vector construction and transfection
  • Clone selection
  • Research cell bank (RCB) creation, testing, characterization
  • RCB stability studies
A row of advanced bioreactor systems with attached wires, tubes, and digital interfaces, all neatly arranged on a long laboratory workbench dedicated to genetic toxicology research. The lab equipment is designed for scientific investigation and appears to be in a pristine and well-lit environment.

Upstream Process Development

  • Culture media screening
  • Feeding strategy definition
  • Process parameter optimization
  • Process lock and confirmation (15 – 50L)
  • Process scale-up
  • Process characterization
  • Technology transfer
A lab technician wearing a white coat and blue gloves handles a test tube. Multiple test tubes, crucial for Preclinical ADME studies, are organized on a tray connected to laboratory equipment in a clean, sterile environment.

Downstream Process Development

  • Platform technology for mAbs and Fc fusion proteins
  • Customized purification processes for recombinant proteins, bi/multi-specific mAbs
  • Cell culture harvest and clarification process
  • Resin screening
  • Chromatography process development
  • Viral clearance studies
  • Ultrafiltration (UF)/Diafiltration (DF)
  • Process characterization
  • Process scale-up
  • Technology transfer
A scientist wearing a white lab coat and blue gloves operates a LUMOS II microscope in a laboratory. The microscope is focused on a sample slide crucial for preclinical ADME studies. The lab has a clean, sterile environment with a stark white backdrop.

Drug Product Development

  • Molecule developability assessment
  • Physiochemical property characterization
  • Stability assessment
  • Forced degradation studies
  • Liquid and lyophilized product development
  • Pre-filled syringe drug product development
  • Container closure compatibility
  • Container closure integrity
  • Extractable and leachable
  • Biophysical characterization
  • Stability studies and data trending
  • Drug product fill-finish process development
  • Technology transfer
  • Tox in-use compatibility and stability studies
  • Clinical in-use compatibility and stability studies
  • Forensic analysis
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