Female scientist

GMP Biologics

During past 20 years, PPD® Laboratories GMP lab has helped customers develop hundreds of biologic pharmaceuticals including more than 70% of the top 50 biologics of 2015 and eight out of the 10 best-selling biosimilars of 2014. Our expertise spans all phases of development — from feasibility to release testing for commercialized products.

Our biologics experience encompasses a variety of molecules:

  • Proteins; monoclonal and polyclonal antibodies, recombinant proteins, hormones, PEGylated proteins, glycosylated proteins, antibody-drug conjugates
  • Peptides and polypeptides
  • Nucleotides/oligonucleotides; siRNA, synthetic oligonucleotides, PEGylated oligonucleotides, DNAi and RNAi
  • DNA, mRNA, plasmids and viral gene therapy products
  • Carbohydrates and polysaccharides
  • Liposomes
  • Inhaled biologics
  • Process impurity assays; host cell protein, host cell DNA, iPTG, surfactants, antibiotics etc.

Our biologics services and capabilities include:

  • Feasibility, method development, qualification and validation
  • Product characterization
  • Forced degradation studies and analysis
  • Stability testing and storage of API and finished products
  • QC testing of API, in-process samples and finished products
  • Release testing for clinical trial material and commercial products
  • Pre-formulation support and formulation evaluation
  • Coagulation analysis (PT, APTT, Anti Xa, Anti IIa, etc.)
  • Cell-based assays