Biopharmaceutical Services

PPD's biopharmaceutical services include the analysis of small and large biomolecules, such as proteins, nucleotides/oligonucleotides, DNA, carbohydrates/polysaccharides and liposomes.

• Proteins
• • Monoclonal and polyclonal antibodies
  • Recombinant proteins
  • Hormones
  • PEGylated proteins
  • Glycosylation
  • Peptides/polypeptides
• Nucleotides/oligonucleotides
• • Synthesis oligonucleotides
  • siRNA
  • PEGylated oligonucleotides
• DNA
• Carbohydrates/polysaccharides
• Liposomes

Biopharmaceutical Services 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, and Anti IIa)
• Cell-based assays

Biopharmaceutical Methods utilized include:

• HPLC chromatography (reverse phase, ion exchange, size exclusion)
• Electrophoresis (agarose, SDS-PAGE, IEF and 2D-gels)
• Capillary Electrophoresis (CZE, CGE, CIEF and CE-SDS)
• Amino acid analysis
• Peptide mapping
• Protein sequence confirmation
• Mass spectroscopy, Q-Tof LC/MS/MS
• Disulfide bond linkage identification and structure elucidation
• ELISA
• Activity assays
• Host cell protein and host cell DNA

Specialized Biopharmaceutical Technologies

• Waters Q-Tof Premier
• • Intact molecular weight determination
  • Peptide mapping
  • Protein sequence confirmation
  • Disulfide bonds number and location determination
  • Glycosylation mapping
  • Oligonucleotide sequencing
  • Oligosaccharide sequencing
  • Protein isoform identification
  • Post-translational modification characterization including glycosylation, phosphorylation, end-capping, etc.
  • Protein-drug interaction including antibody-ligand, enzyme-substrate, protein-cofactor, etc.
  • Identification of large molecule degradations by molecular weight determination, peptide mapping, disulfide bond determination, post translational modification and glycosylation mapping
  • Biopolymer analysis
• Beckman Coulter P/ACE™ MDQ capillary electrophoresis systems CZE, CGE, CIEF:
• • Detection: UV, PDA and LIF
• Gel electrophoresis: SDS-PAGE, Native PAGE, IEF, 2D-gels and Agarose Gel
• Quantitative densitometry
• ELISA
• HPLC: RP, SEC, HIC, IEX, HAC and affinity (metal and dye) modes:
• • Detection: UV/Vis, PDA, RI, ELSD, MS and FL
• Peptide mapping: HPLC and LC/MS/MS
• Amino acid analysis (AAA)
• Carbohydrate analysis and glycosylation:
• • Colorimetric, CE, GC/MS, LC/MS and PDA
• Enzyme-activity analysis including Km/Kcat
• Residual protein, nucleic acid and chemical analysis
• Antibiotics, chelators, PEG host cell DNA and host cell protein quantitation/detection
• Applied Biosystems 7500 Real-Time PCR System
• Protein content
• UV, fluorometry, colorimetric and AAA quantitation/detection
• Extinction coefficients and empirical determination
• MALS: Wyatt Technology Wyatt miniDawn with Optilab DSP and Wyatt Dawn EOS with Optilab rEX and WyattWELSTM:
• • Protein-protein interaction
  • Protein aggregation
  • Stoichiometry of protein-protein complexes
• Beckman and Bio Merieux Coagulation Analyzers
• Preparative and Semi Prep-LC
• Blotting, including Western, Northern and Southern