Formulation and Final Fill Finish

Purification scientists work with Leinco Technologies’ clients to establish the specifications for final product formulation and packaging. Bulk packaging and vialing capacity is available.

Documentation

Purification of recombinant proteins and antibodies is performed using standard operating procedures (SOP’s) and cGMP compliant batch records. Upon completion of a purification batch, a master production file is archived and bio-analytical lot release testing records are provided to clients.

Antibody and Protein Purification

Leinco Technologies has developed robust multi-step purification procedures for recombinant proteins and antibodies for use in early discovery research, preclinical trials and In vitro medical devices. A variety of scales from laboratory to commercial manufacturing are available. Development of a purification procedure is based on the final product application and predetermined specifications. In most antibody cases, a robust procedure beginning with protein A chromatography followed by other proprietary chromatography steps result in a highly pure antibody preparation. For In vivo functional studies or preclinical trial materials, procedures resulting in preparations free of aggregates, DNA, viruses, leached protein A and low endotoxins are available.


  Examples of Chromatography Available:

  • Protein A Affinity
  • Protein G Affinity
  • Ion Exchange
  • Antigen Affinity
  • IMAC
  • CHT
  • Hydrophobic Interaction
  • Size Exclusion Chromatography (SEC)


  Bio-analytical Lot Release Testing Offered:

  • SDS Page Analysis for Purity
  • FPLC Analysis for Purity and % Aggregates
  • Isoelectric Profiling (IEF) for Identity
  • Concentration Determination
  • Protein A / Antibody Ratio
  • Sterility
  • Mycoplasma Testing
  • Endotoxin Testing
  • Biological Activity
  • Conductivity
  • pH Determination
  • Freeze Thaw Recovery

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