The advantages of using AAIPharma Services - Expertise and Focus
Our dedicated cGMP biotechnology laboratory seamlessly supports the R&D, QC/Stability and manufacturing programs of our clients. The biotechnology staff, including a scientific team of 5 PhDs, has strong expertise in molecular biology, biochemistry, chemistry, protein chemistry, toxicology, and mass spectrometry. We have extensive experience in biotechnology development to support Phase I through Phase III clinical studies for peptides, proteins, monoclonal antibodies, carbohydrates as well as high molecular weight polymeric drugs in solid dosage forms, parenteral – liquid and lyophilized, transdermal patches and liquids.
We offer:
- Method Development and Validation
- Potency (Chromatographic Procedures, ELISA, Cell Based Bioassays)
- Degredant, Impurity, Quantitative Analysis of Drug Substance or Drug Product
- N-Terminal Sequencing
- Peptide Mapping
- Amino Acid Analysis
- Host Cell Contaminant Analysis (Residual DNA or Protein)
- Carbohydrate Analysis
- Chelators and PEG
- LAL
- Cleaning Validation
- Stability Studies
- Analytical Support for Large Molecule Formulation Development including additional Staff of 3 PhDs to assist in Complex Analytical/Formulation Related Programs
- Isolation and Identification of Impurities
- QC Testing: In-Process, Release and Stability
- In-Sourcing Analytical Support
- Provide Trained and Experienced Analysts to work in Client’s Facility
- Project Management
- All Biotechnology Projects are supported by Comprehensive Project Management Consisting of a Dedicated Project Manager and a Dedicated Technical/Operations Leader
