AAIPharma Services, “The Preferred Partner for API Manufacturers”

•  Dedicated team for large molecule programs includes five PhDs to exceed ICHQ6 Guidance

•  Excellent reputation for responsiveness, problem solving, and reliable outcomes

•  Supported more than 500 large molecule programs over the past 20 years

•  cGMP compliant with robust quality systems

•  Seamless integration with Microbiology, Preformulation, Formulation Development, Stability and

    Manufacturing

•  Experienced Project Management team to ensure scope and timeline are communicated and achieved

 AAIPharma Services has the experience, capabilities and capacity to deliver quality results on time and on budget.  Our dedicated cGMP Large Molecule Analytical team, located in our new Technology Center (Wilmington, NC), routinely supports API Manufacturers of biopharmaceuticals with the following dependable cGMP services:

•  Amino Acid Analysis (AAA)

•  N-Terminal Sequencing

•  Glycan Analysis

•  Molecular Weight Determination

•  Isolation & Identification of Unknowns

•  Extinction Coefficient Determination

•  Dye-based Protein Assays (BCA, Lowery, Bradford)

•  Electrophoresis (SDS-PAGE, Agarose (DNA/RNA) Isoelectric Focusing, Western Blot)

•  Endotoxin by LAL (Kinetic Chromogenic and Turbidimentric)

•  Bioactivity Assay (Cell-based bioassays:  UV-Vis, Fluorescence, Luminescence, RI)

•  ELISA (Direct, Indirect, Competitive, Oligonucleotide-DIG)

•  Enzyme Activity Assays (kinetic, endpoint)

•  Capillary Electrophoresis:  (MW analysis, cIEF, ss-DNA, IgG purity/heterogeneity, Carbohydrate analysis)

•  Safety Testing (Residual Host Cell DNA by Threshold, Residual Host Cell Protein by Threshold)

 Partial Listing of cGMP compliant equipment includes:

•  Waters Q-TOF Premier mass spectrometer with ESI, MALDI, & nano-spray ionization sources and Acquity®   

    UPLC (UPLC/QTOF)

•  PE Sciex API5000 triple quadrupole mass spectrometer

•  PE Sciex API365 triple quadrupole mass spectrometers (2 units)

•  GC/MS Agilent 7890A/5975C GC/MS and 6890N/5975B GC/MS systems with liquid and headspace samplers

    and FID detectors

•  Semi-Prep HPLC and Automated Fraction Collection

•  CE-LIF Beckman ProteomeLabTM PA 800 Protein Characterization System

•  ABI Procise® Sequence System

 AAIPharma Services is a dependable & fully integrated analytical testing, contract development, and manufacturing organization.  AAIPharma Services supports the global drug development and production needs for pharmaceutical, biotech and drug delivery companies.  This is all accomplished with our experienced staff consisting of approximately 550 employees and five regional sites across Central and Eastern USA.  Our customers may choose from specific services or a complete development and manufacturing program encompassing the full continuum of pharmaceutical product development services – from clinical development to commercial manufacturing.  Please visit www.aaipharma.com for more information on our dependable services.

To complete this form, please visit our site in a desktop browser.