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Recombinant Proteins & Peptides

With 20+ years of E. coli-based process development, One 2 One is a world-leading manufacturer of custom, recombinant proteins and peptides.

ONE 2 ONE COMFORT ZONE
CUSTOM COMMERCIALIZATION
Product Development
Specialized Development Services
International Regulatory Expertise
Commercial Services
PARENTERAL MANUFACTURING
WORLDWIDE EXPERIENCE
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Characterization / Purification Assays Analytical Assays
  • RP-HPLC, FPLC
  • Mass spectrometry
  • Peptide mapping
  • N-terminal sequence
  • Iso-electric focusing
  • SDS-PAGE
  • DNA blot
  • Wet/dry cell mass
  • Vector Integrity
  • Amino acid analysis
  • Endotoxin (chromogenic LAL)
  • Bioburden
  • Host cell protein (Western/ELISA)
  • Stability indicating assays
  • Release Assay

Process Design

Using a toolbox of proprietary expression sequences and fusion protein technologies that drive high level expression, protEcol™ Services offers:

  • Expression construct design
  • Integration into vectors
  • Plasmid evaluation in cell line (qualified for production of human therapeutics)
  • PEGylation to the N-terminus
  • C-terminal amidation

Process Development

protEcol™ Services combines scientific expertise and engineering capabilities to develop reproducible, efficient and scalable processes appropriate for large scale manufacture, in accord with GMP. Dedicated teams specialize in the optimization of upstream and downstream processes, analytical development, quality control and assurance.

Scale-up and Technology Transfer

protEcol™ Services currently offers scale-up processes to 500 L capacity. Technology transfer production processes, analytical assays and cleaning methods are qualified, validated and documented. protEcol™ Services can also provide assistance with Chemistry, Manufacturing and Control section submissions.

GMP Manufacture

protEcol™ Services offers cGMP manufacture of API as well as cGMP manufacture and testing of master and working cell banks with long term storage at -80°C. Coordinated through One 2 One centralized management, protEcol™ Services assists with lyophilization development and manufacture and fill/finish services.

Manufactured in Adelaide, Australia



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This Web site and its information is intended for use by United States residents only. Countries outside the United States may have regulatory requirements, data requirements or medical practices that differ from the United States and, therefore, this information may be inappropriate for use outside the United States. Site contents are intended for informational purposes only and not intended to replace discussion with a healthcare provider. If you have any questions regarding this site, contact Hospira.
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