About Us
What we do
Provide consulting services to the pharmaceutical and biotechnology industries in the analytical, biophysical, biochemical, and bioengineering sciences in support of drug discovery and development of small-molecule, protein, and cell therapy modalities. Specializing in:
- Developing strategic Quality by Design initiatives through establishing and characterizing therapeutic Critical Quality Attributes in support of a robust manufacturing design space.
- IND enabling activities in support of CMC and PK/DM efforts.
- Stabilization of therapeutics in the liquid-, cryo-, and solid-states
- Analytical and biophysical development strategies in support of pre-formulation and formulation development activities
Specializing in Challenging Biophysical Problems
- We are an Analytical Biophysics design and analysis go-to organization. Structure-Function Characterization of protein and cellular therapies in support of CMC activities.
- We love bio-thermodynamics! Solving equilibrium binding, assembly, kinetics, enzymology, inhibition, and functional assay problems is our specialty.
- Experimental design
- Data analysis
- Global fitting
- Biophysical Contract Research
- Analytical Ultracentrifugation (AUC)
- Differential Scanning Calorimetry (DSC)
- Surface Plasmon Resonance (SPR)
- Isothermal Titration Calorimetry (ITC)
- Protein Conformational Analysis: Circular Dicroism (CD), FTIR, and Florescence spectroscopies
Unique and Thorough
Whether discovering a new therapeutic or developing a Biosimilar, we will help you with a robust strategy and approach, an understanding of the data and results, and a scientific, regulatory, and businesses minded assessment of your drugs needs.
Our Partners
Meet the Team
John J. Hill, PhD
A preclinical development, and development scientist with over twenty years of leadership experience in managing and applying analytical, biophysical, bioanalytical, biochemical, and bioengineering approaches to interdisciplinary research and development problems in the biopharma and academic settings. Highly experienced in establishing, characterizing, and managing the critical quality attributes of biologic, small molecule, and cellular therapeutics; including their mechanism of action, potency, purity, and stability in support of process development, pre-formulation, formulation, drug delivery,
PK/DM, and diagnostics operations.