Discover Our Analytical Pipeline

Program PQS ASP
Humira®
Dupixent®
Keytruda®
Cosentyx®
Ocrevus®
Darzalex®
Entyvio®
Simponi®
Stelara®
Nucala®
Opdivo®
Herceptin®
Rituxan®
Avastin®
Remicade®
Actemra®
Perjeta®
Prolia/Xgeva®
Tecentriq®
Tysabri®
Tremfya®
Yervoy®
Imfinzi®
Skyrizi®
Fasenra®
Repatha®
Taltz®
Ultomiris®
Hemlibra®
Enbrel®

What Comes with Our Analytical Data Packages

Tail Product Quality Summary (PQS)

Product Quality
Summary (PQS)

Quality Target Product Profile

  • Primary structure
  • Critical post-translational modifications (PTMs)
  • Glycan distribution
  • Charge distribution
  • Size distribution
  • Product-related substances & impurities
  • Summary data from at least six lots of reference product

Analytical Target Profile

  • Methods / techniques required for submission
  • Testing frequency (release/stability/similarity/characterization)
  • Performance requirements

Putative Specification

Tail Analytical Starter Package (ASP)

Analytical Starter
Package (ASP)

Analytical Methodologies

Entirety of the PQS, additionally includes:

  • Peptide mapping procedure
  • Glycan mapping procedure
  • cIEF procedure
  • SEC procedure
  • R and NR SDS-CGE procedures
  • Potency procedure
  • Titer procedures
  • Reference product data from individual lots
 

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